Date Posted:

8/16/2008

 

Job ID:

1642

 

Company:

The medical research foundation is dedicated to bringing advanced medical technologies to the public to provide significant improvements to the health, security, and quality of life for people suffering from debilitating medical conditions. Insulin injections, diabetes, pancreas, implantable glucose sensor, insulin pump, Type 1 diabetes, disease, blood sugar, cochlear implant, hearing loss, telemetry, technology, microstimulator implant, hemiplegic, stroke, incontinence, migraine headaches, clinical trials, paralyzed limb, Bradycardia, heart, pacemakers are just some of the platforms being worked on . Pioneering development work for an implantable glucose sensor for continuous monitoring of blood sugar levels in diabetics. The sensor used in conjunction with insulin delivery pump can achieve a totally automated delivery process of insulin tailored to patients’ blood sugar level. The Foundation continues development of a new generation long-term glucose sensor. This exciting technology could eventually replace a nonfunctioning pancreas. Cochlear Implant Development . Developing a magnetically controlled and powered injectable neuromuscular stimulation device for impaired neural and muscular functions for the treatment of migraine headache and urinary incontinence. New Product Development, the Injectable Microstimulator System In the US alone, 4.6 million people suffer from stoke and as many as 30% of these patients are presently paralyzed. In 1999, more than 1,100 000 American adults reported difficulty with functional limitations, activities of daily living, etc, resulting from stroke (SIPP).To address this need the R&D team at THE FOUNDATION is developing a system of battery powered injectable microstimulators and microsensors, each of which can be controlled and monitored up to 100 times a second via radio communication. This system is intended to restore function to partially paralyzed limbs. For a stroke patient with partial paralysis, it will appear to as though he has regained control of the limb. THE FOUNDATION hopes to make the process of injecting the devices a simple office procedure, reducing the cost of an out patient, surgical procedure.

 

Location:

Upper Southern California

 

Reports To:

Director Engineering

 

Salary:

$90 - $110

 

Education:

MSEE or equivalent.

 

Requirements:

Minimum 5 - 10 years experience with analog and digital design. Bench experience troubleshooting prototype designs. Experience with developing projects from concept to manufacturing. Ability to meet deadlines and work in project teams. Excellent communication skills both written and oral. Coil design and switched-mode power supply design is a plus. Medical device experience is a plus. Experience with medical electrical device safety and EMC testing is a plus.

 

Duties:

Develop and prototype electronic circuit designs for external medical device equipment supporting active medical implant technology. Apply engineering and scientific principles to the evaluation and solution of technical problems; create and implement verification and validation testing plans and procedures. Work will involve all phases of product development from concept through qualification and field test & support. Document the engineering design and test plans and results. Work closely with numerous departments to ensure timely delivery of a quality product.

 

Date Posted:

8/16/2008

 

Job ID:

1641

 

Company:

The medical research foundation is dedicated to bringing advanced medical technologies to the public to provide significant improvements to the health, security, and quality of life for people suffering from debilitating medical conditions. Insulin injections, diabetes, pancreas, implantable glucose sensor, insulin pump, Type 1 diabetes, disease, blood sugar, cochlear implant, hearing loss, telemetry, technology, microstimulator implant, hemiplegic, stroke, incontinence, migraine headaches, clinical trials, paralyzed limb, Bradycardia, heart, pacemakers are just some of the platforms being worked on . Pioneering development work for an implantable glucose sensor for continuous monitoring of blood sugar levels in diabetics. The sensor used in conjunction with insulin delivery pump can achieve a totally automated delivery process of insulin tailored to patients’ blood sugar level. The Foundation continues development of a new generation long-term glucose sensor. This exciting technology could eventually replace a nonfunctioning pancreas. Cochlear Implant Development . Developing a magnetically controlled and powered injectable neuromuscular stimulation device for impaired neural and muscular functions for the treatment of migraine headache and urinary incontinence. New Product Development, the Injectable Microstimulator System In the US alone, 4.6 million people suffer from stoke and as many as 30% of these patients are presently paralyzed. In 1999, more than 1,100 000 American adults reported difficulty with functional limitations, activities of daily living, etc, resulting from stroke (SIPP).To address this need the R&D team at THE FOUNDATION is developing a system of battery powered injectable microstimulators and microsensors, each of which can be controlled and monitored up to 100 times a second via radio communication. This system is intended to restore function to partially paralyzed limbs. For a stroke patient with partial paralysis, it will appear to as though he has regained control of the limb. THE FOUNDATION hopes to make the process of injecting the devices a simple office procedure, reducing the cost of an out patient, surgical procedure.

 

Location:

Upper Southern California

 

Reports To:

VP Research and Development

 

Salary:

depends on exp./ level $125k +

 

Education:

BA

 

Requirements:

Bachelors degree from four-year college or university in life sciences, statistics, physics or engineering; and five to seven years related experience and/or training in FDA regulatory affairs and clinical research; or equivalent combination of education and experience.

 

Duties:

This position handles worldwide submissions and compliance activities and preparing regulatory applications, acting as primary interface with FDA, registrars and other regulatory bodies in order to obtain and maintain approvals to perform clinical evaluations of products developed by the Company

 

Date Posted:

8/16/2008

 

Job ID:

1640

 

Company:

The medical research foundation is dedicated to bringing advanced medical technologies to the public to provide significant improvements to the health, security, and quality of life for people suffering from debilitating medical conditions. Insulin injections, diabetes, pancreas, implantable glucose sensor, insulin pump, Type 1 diabetes, disease, blood sugar, cochlear implant, hearing loss, telemetry, technology, microstimulator implant, hemiplegic, stroke, incontinence, migraine headaches, clinical trials, paralyzed limb, Bradycardia, heart, pacemakers are just some of the platforms being worked on . Pioneering development work for an implantable glucose sensor for continuous monitoring of blood sugar levels in diabetics. The sensor used in conjunction with insulin delivery pump can achieve a totally automated delivery process of insulin tailored to patients’ blood sugar level. The Foundation continues development of a new generation long-term glucose sensor. This exciting technology could eventually replace a nonfunctioning pancreas. Cochlear Implant Development . Developing a magnetically controlled and powered injectable neuromuscular stimulation device for impaired neural and muscular functions for the treatment of migraine headache and urinary incontinence. New Product Development, the Injectable Microstimulator System In the US alone, 4.6 million people suffer from stoke and as many as 30% of these patients are presently paralyzed. In 1999, more than 1,100 000 American adults reported difficulty with functional limitations, activities of daily living, etc, resulting from stroke (SIPP).To address this need the R&D team at THE FOUNDATION is developing a system of battery powered injectable microstimulators and microsensors, each of which can be controlled and monitored up to 100 times a second via radio communication. This system is intended to restore function to partially paralyzed limbs. For a stroke patient with partial paralysis, it will appear to as though he has regained control of the limb. THE FOUNDATION hopes to make the process of injecting the devices a simple office procedure, reducing the cost of an out patient, surgical procedure.

 

Location:

Upper Southern California

 

Reports To:

 

Salary:

$100k+

 

Education:

Business and/or Science Degree, MBA preferred

 

Requirements:

7 – 10 years experience in a medical related field. Knowledge of implantable medical devices. Project management responsibilities for medical products from planning, design, development, production and success product launch. Ability to travel some percentage of time. Proficient with MS office software including Powerpoint, Word, Excel Must have excellent verbal and written communication skills.

 

Duties:

The successful candidates will have experience preparing market analysis and business plans for new projects and applications; including assessment of risks, competitive landscape, market opportunity, barriers to entry, barriers to exit and reimbursement opportunities. The candidate will act as liaison to between industry collaborators, other Al Mann Companies and our technical team to build solutions that meet the businesss needs.

 

Date Posted:

8/16/2008

 

Job ID:

1639

 

Company:

The medical research foundation is dedicated to bringing advanced medical technologies to the public to provide significant improvements to the health, security, and quality of life for people suffering from debilitating medical conditions. Insulin injections, diabetes, pancreas, implantable glucose sensor, insulin pump, Type 1 diabetes, disease, blood sugar, cochlear implant, hearing loss, telemetry, technology, microstimulator implant, hemiplegic, stroke, incontinence, migraine headaches, clinical trials, paralyzed limb, Bradycardia, heart, pacemakers are just some of the platforms being worked on . Pioneering development work for an implantable glucose sensor for continuous monitoring of blood sugar levels in diabetics. The sensor used in conjunction with insulin delivery pump can achieve a totally automated delivery process of insulin tailored to patients’ blood sugar level. The Foundation continues development of a new generation long-term glucose sensor. This exciting technology could eventually replace a nonfunctioning pancreas. Cochlear Implant Development . Developing a magnetically controlled and powered injectable neuromuscular stimulation device for impaired neural and muscular functions for the treatment of migraine headache and urinary incontinence. New Product Development, the Injectable Microstimulator System In the US alone, 4.6 million people suffer from stoke and as many as 30% of these patients are presently paralyzed. In 1999, more than 1,100 000 American adults reported difficulty with functional limitations, activities of daily living, etc, resulting from stroke (SIPP).To address this need the R&D team at THE FOUNDATION is developing a system of battery powered injectable microstimulators and microsensors, each of which can be controlled and monitored up to 100 times a second via radio communication. This system is intended to restore function to partially paralyzed limbs. For a stroke patient with partial paralysis, it will appear to as though he has regained control of the limb. THE FOUNDATION hopes to make the process of injecting the devices a simple office procedure, reducing the cost of an out patient, surgical procedure.

 

Location:

Upper Southern California

 

Reports To:

Director Engineering

 

Salary:

$75 - $120K

 

Education:

Masters degree (M. S.)

 

Requirements:

Undergraduate degree in Electrical Engineering desired, equivalent may be an Engineering Technology degree, or equivalent work experience typically 8-10 years would be acceptable. Masters degree (M. S.) from four-year college or university in Electrical Engineering specializing in RF communication, analog, digital, and instrumentation; or 5 to 7 years related experience and/or training; or equivalent combination of education and experience. Must have RF test experience with digital signal processing and/or Application specific integrated circuit test experience.

 

Duties:

The successful candidate will design, research, simulate, and integrate test equipment, methods, and fixtures as necessary to test receivers and transmitter chains, both analog and digital, for low power multi propose in-body implemented wireless implantable systems.

 

Date Posted:

8/14/2008

 

Job ID:

1638

 

Company:

We are a Dental company creating state of the art 3D imaging technology with the capacity to provide precise models of a patient’s teeth by taking an intra oral optical impression. Our technology will do away with the conventional messy and distasteful impression process now being used and is poised to transform restorative dentistry.

 

Location:

CA

 

Reports To:

CEO

 

Salary:

$110K to $130K depending on experience

 

Education:

BA or MS degree in Computer Science, mathematics, physics, engineering or related field.

 

Requirements:

The ideal candidate will be multidisciplined in the areas of software engineering, robotics engineering, and vision systems and have 5+ years of product development in the medical or laboratory device field. Technical training or experience in robotics and optical instrument development methods and techniques preferred. Requires 3+ years hands on experience with Microsoft Visual Studios C++ version 2005 used to develop system level applications for machine or instrument control in a Windows XP environment. Experience with Matlab, 2D and 3D graphics tools, Open CV and a strong image processing background is desired. Must be hands on and detail oriented with good mathematical and analytical ability and a proven track record of developing and releasing software for commercial products. The ideal candidate will be a highly self-motivated individual with a high degree of creativity and the ability to focus on complex tasks and drive them to completion.Experience with relevant regulatory requirements for a medical device is a plus.

 

Duties:

Job Summary: Hands-on, leadership role in the development and integration of medical device quality software with systems involving robotics, computer vision, and complex 3D modeling of surfaces. Current experience with, and strong competency in, development of Windows XP based applications using MS Visual Studios 2005 is essential. Responsibilities: Plan, design, write, and test software and algorithms developed for the Companies FastScan intra oral dental impression system. Collaborate with engineering staff , marketing, and dental professionals in the design, development, deployment, and maintenance of software applications. Contribute to the Software Engineering effort on a high-level in cross-functional project teams that identify project specifications, develop system architectures, allocate requirements and carry out the necessary effort. May interface with manufacturing in the transition of assigned projects. Troubleshoot the most challenging problems and, in collaboration with other members of the software team, recommend and implement solutions. May directly supervisor or indirectly guide and mentor other software engineers.

 

Date Posted:

8/12/2008

 

Job ID:

1637

 

Company:

We are a leading global clinical research organization (CRO). We have proven proficiency in supporting worldwide clinical trials for medical device, pharmaceutical and biotechnology companies. We have an influential focus in the areas of Cardiovascular Diseases, Oncology and Medical Devices. We are devoted to providing clients with crucial thinking, customer service and quality deliverables. We are committed to making sure that each clinical trial is performed to the highest possible standards.

 

Location:

Massachusetts

 

Reports To:

CMO

 

Salary:

Commensurate with experience up to 220k

 

Education:

Medical Degree (MD)

 

Requirements:

5-7 years industry experience including and at least 3 years clinical trial experience; minimum 5 of industry experience and/or clinical trial experience with drugs, devices or biologics. Medical license required. Board certification preferred. Management experience is preferred. Excellent organizational skills with ability to work in a high volume and strict deadline environment. Proficiency in operating computers applications and navigating the internet. Excellent interpersonal skills. Excellent verbal and written communications skills. Ability to work independently Strong leadership and management skills. Ability to handle multiple projects simultaneously and manages multi-functional teams; must have creative problem solving skills; excellent verbal / written communication skills. Excellent time management and organizational skills. Excellent knowledge of the drug development process. Preferred Qualifications Experience with clinical development plans of new chemical entities, biological products and devices, experience working with or for a CRO. Experience with CDER, CBER, CDRH and international regulatory agencies is a plus.

 

Duties:

POSITION SUMMARY: Provide leadership and supervision with a Cardiovascular or Device focus within the Medical Affairs group. The Medical Director will have responsibility for successful clinical input and medical monitoring for multiple clients, guidance and support to project teams, interface with Sponsors and Regulatory authorities, provide training to in-house staff on protocols and therapeutic areas, work with Sponsors and Medical Affairs group in protocol development and/or review, interact with Clinical Safety department and Investigators regarding pharmacovigilance and study implementation. Provide direct and supportive medical services to multiple clients, including the following: Interact with the Sponsor in protocol review or development. Perform literature analysis of therapeutic area involved in Sponsor clinical development. Manage all aspects of medical monitoring specifically focusing on Cardiovascular or Device inclusive of patient eligibility, protocol deviations, and protocol interpretation. Work in matrix environment with Clinical Affairs (Project Managers, Lead CRAs, etc), Data Management and Biometrics. Create team structures including a defined decision-making process that supports objectives and meets timelines. Communication with clients and Client Project Managers to promote project schedule adherence, ensure that projects are adequately staffed with personnel and resources, and meet high quality standards. Provide guidance on medical and scientific issues, interact with principal investigators and opinion leaders. Development and maintenance of work guidelines, department metrics and project tools. Coordinate training and education programs to ensure staff is trained as needed, including but not limited to relevant therapeutic areas, ICH guidelines, and regulatory requirements. Collaborate with staff inter- and intra-departmentally on the proposal development process. Make presentations and represent Company at professional meetings and with prospective and existing clients. Participate in business development presentations as required. Manage personnel activities, and provide guidance for professional development of staff (coordinate resource distribution across projects, interviews, makes hiring recommendations, leads disciplinary actions, delivers performance reviews) with a focus in therapeutic expertise. Other duties may be assigned. Additional Duties and Responsibilities: Participate in staffing the Company exhibit booth at medical conferences. Participate in business development visits to current and potential clients. Contribute to scientific publications by reviewing for scientific accuracy, content, consistency and conclusions. Collaborate with business development in review, writing, presentation and defense proposals. Perform all other duties as assigned.

 

Date Posted:

7/10/2008

 

Job ID:

1634

 

Company:

We are the top worldwide supplier of electronic Patient Reported Outcomes for the life science industry. Through ground-breaking technology and a complete understanding of mobile computing, we are driving the change to paperless clinical trials which are more efficient and safer. Our mission is to become the preferred enterprise data capture partner of the pharmaceutical industry.

 

Location:

This is a virtual office position- Corp is in MA

 

Reports To:

VP Commercial Operations

 

Salary:

98-118K base plus commission might be up to 147K to 177k

 

Education:

Bachelor degree a must. MBA a nice to have but not at the expense of anything else, especially clinical operations knowledge and technology solution selling experience.

 

Requirements:

Knowledge of Implementation services and methodologies in engagements ranging from Clinical Trial Protocol development thru concept Diary development and proposal submission as well as systems validation (i.e. Installation qualification (IQ), operational qualification (OQ) & performance qualification (PQ) services.) Accustomed to frequent travel, domestic and some international as required. Ability to give sales presentations and brief, high level demonstrations with the Company products. Experience in fast paced environment – self starter. Person must be highly accountable for weekly sales activities. This is a virtual office position. Outstanding work ethic and the discipline to work hard without supervision. This is not a 9-5 position. Knowledge and track record of telephone surveying of company contacts at all levels for prospect identification development. This is a significant key skill for the position. Ability to analyze process Clinical Operations data collection and reporting Process operation bottlenecks, develop business case for investment, prepare the proposal and close deal. In other words- define and execute a complex consultative selling process to address manual, paper based processes in the clinical operations area. Strong interpersonal, oral and written communication skills. Proficient knowledge of MS Office Applications (MS Office and higher), regulatory agencies( FDA, HMA, EMEA, etc) policies and practices for clinical operations Patient data collection and reporting, Computer Systems Validation, Electronic Records Electronic Signature (ERES), Pharmaceutical Industry clinical trial operations. Proven track record of achieving annual quota objectives at least of at least $2.5mm euros in services and license fee sales. Knowledge of and working familiarity of sales process, i.e., Value Based Selling, Holden Power Base Selling, Miller Hieman LAMP, Sandler, etc. Familiarity with total enterprise involvement selling and comfort in selling at all levels of the enterprise. Use CRF management in tiered approach in reaching the contract signor, or key decision maker. Must be knowledgeable of consultative selling process including business process analysis and cost benefit solutions sales justification. Candidates must be able to understand and prosper in 6-8 month sales cycles. Must be driven, tenacious, committed, professional, creative and “hate to lose” competitive individual.

 

Duties:

The regional Director of Business Development is a senior level, “hunter” direct sales, customer relationship and territory management position focused on selling the Company’s eDiary Solution and related implementation support services to the Life Science, regulated industries (pharmaceutical, Biotechnology and Medical Device). Work with named accounts to successfully produce leads and close sales. Contact new prospects at the most senior levels, including CEO’s, Sr. VPs of R&D and Clinical Operations in named territory and specified accounts to develop interest in company’s eClinical/ePRO software and support services. Analyze accounts and develop account penetration plan to increase future business growth as well as expansion of those clients currently using CRFs products, if assigned. Maintain established account relationships, if assigned, and develop opportunities to up-sell additional software and services. Work as a team member and assist Company Market penetration effort with direct mail, telephone and e-mail communication to selected companies. Helpful Application software knowledge: ePRO, IVRS, IWRS, EDiary, EDC, CTMS, CTDM. Major account development at large multi-division, multi-site pharmaceutical, medical device, biotech and contract manufacturers.

 

Date Posted:

7/10/2008

 

Job ID:

1633

 

Company:

We are a primary provider of software, calculated consulting, and regulatory services for performing clinical pharmacology development. Our database Server for the storage, management, analysis, and regulatory reporting of derivative data and models in data repositories for efficient on-site validation; and Drug Model for vibrant visualization and communication of sample-based product profiles. Our company develops and markets integrated products and services that allow pharmaceutical and biotechnology companies to attain major and lasting improvements in the development and use of therapeutic products. Company strives to help customers reduce the time, cost and risk of drug development. We enhance drug development decision-making and efficiency through our services.

 

Location:

North Carolina

 

Reports To:

VP of Operations

 

Salary:

175 to 195 k

 

Education:

Pharm D, BS or MS in Pharmacology, Chemistry, Biology, Biostatistics, Bioinformatics or other Life Sciences.

 

Requirements:

10+ years experience preferred. Proven history of successful leadership and management. Demonstrated knowledge of clinical research. Thorough understanding of statistical modeling. Ability to search large sets of data and make judgments about applicable data usage. Advanced skills in and abilities to review and QA large amounts of data required. Ability to foster proactive cross-functional working relationships within Scientific Modeling group, Marketing, Sales and Legal Departments. Excellent leadership, management, communication and interpersonal skills. Data management skills. Attention to detail.

 

Duties:

Provide primary leadership role within the Clinical Database Services group. Provide pharmaceutical based consultation to services groups. Provide vision and direction to business development activities. Develop therapeutic area monographs to assist work plan scoping. Develop budgets for developing meta-databases from public data sources. Provide expert consultation to Sales, Marketing and Legal departments. Author clinical support documentation, database overview documents and formal bibliographies associated with the completion of database deliverables. Develops and maintains applications systems for the management and analysis of data. Maintain and improve quality systems for meta-database offerings.

 

Date Posted:

7/2/2008

 

Job ID:

1632

 

Company:

We are a primary provider of software, calculated consulting, and regulatory services for performing clinical pharmacology development. Our database Server for the storage, management, analysis, and regulatory reporting of derivative data and models in data repositories for efficient on-site validation; and Drug Model for vibrant visualization and communication of sample-based product profiles. Our company develops and markets integrated products and services that allow pharmaceutical and biotechnology companies to attain major and lasting improvements in the development and use of therapeutic products. Company strives to help customers reduce the time, cost and risk of drug development. We enhance drug development decision-making and efficiency through our services.

 

Location:

North Carolina

 

Reports To:

CEO

 

Salary:

180-225k

 

Education:

Advanced degree in Computer Science/Engineering/Mathematics or other related technical field.

 

Requirements:

A minimum of 10 years of senior technology management experience developing and deploying complex software products to Fortune 2000 companies, including recent experience leading a 30+ person organization. A proven track record of delivering world-class, large-scale, performance critical multimillion-dollar software product projects on time, on budget and with quality to external clients. Significant and proven experience in operational excellence with a thorough understanding of software development organizational processes including architecture, iterative development, program management, user-centered design and testing automation. First-hand experience with the latest software engineering productivity, quality, and cost control methodologies with a proven track record of delivering quality products within defined time constraints and within budget. Deep understanding of agile methods and software engineering development cycle. Sound knowledge in Unix (server) and Windows (server and desktop) development, web application/services development & deployment, object-oriented system architecture and APIs, C++, .NET, Javascript, SQL. Familiarity with reporting requirements for clinical/pre-clinical pharmacology, DMPK, or clinical/pre-clinical pharmacokinetics departments a plus. Experience with technical and/or scientific applications a plus. Capable of managing and motivating an entrepreneurial, high-energy, high-quality, high-output software development organization. Proven leadership and mentoring skills with the ability to work effectively with executive management. Have a passion for developing within the team a strong understanding of customer needs and establishment of operational standards necessary to meet and exceed those needs. Ability to present complex technical information in a clear and concise manner to a variety of audiences, including non-technical. Experience and comfort operating in a dynamic environment where requirements might shift to meet changing business needs. Ability to align best business practices with companys mission and values. Superior organizational and planning skills with excellent written and verbal presentation skills. Travel Required: 5-10%. # Employees Supervised: Team of approx. 30 with 6 direct reports.

 

Duties:

The VP of R&D will be responsible for leading the design, development, quality engineering, quality assurance and technical publications functions of the engineering organization. As a key member of the business unit management team, the executive must provide the leadership and direction necessary to maintain the focus and drive of an exceptionally bright and technically diverse engineering team. The VP of R&D will focus on transitioning engineering into a world-class execution team and will apply deep technical and organizational understanding to making tough decisions and ensure accountability for all deliverables. The VP of R&D will be a proven expert in the field and will be responsible for developing and implementing the strategy for software development processes, tools and metrics for the group. The executive will participate in strategy, planning and technical meetings with business leaders and will provide strong leadership in the technical portion of that strategy. The organization will also look to the VP of R&D to identify best practices and to institute a program of continual process improvement. The VP of Engineering will be a hands-on leader with a passion for building compelling customer experiences and a proven ability to grow and lead a team of talented engineers and managers through design, development, testing and launch of cutting-edge software products. One of the primary measures of the successful candidates performance, in addition to meeting or exceeding the groups commercial goals, will be the ability to mold diverse development groups into a seamless team with a common goal and vision. Essential Job Functions: Direct all aspects of the company’s software development efforts to ensure that product development, testing and ongoing maintenance milestones are accomplished with success in schedule adherence, budget compliance and product quality. Ensure a credible implementation plan is in place when the product release content is approved by the executive team. Provide leadership in the review of existing technology and solutions and determine appropriate strategy for technology and architecture. Energize the organization to maintain continuous improvement programs and explore creative ideas on significantly improving performance. Work closely with Product Management to guide the functional and technical direction of our core products and to provide strong leadership for the technical portion of that strategy. Implement organizational procedures that support product development. Work with executive management to understand business drivers, marketing requirements and competitive issues that may impact departmental strategies. Mentor high-potential managers to assume greater future responsibilities.

 

Date Posted:

6/30/2008

 

Job ID:

1630

 

Company:

We are a research-driven pharmaceutical company. We have a long history of ground-breaking developments in pharmaceuticals and biotechnology. We lead the world in the discovery and development, manufacturing and marketing of vaccines and pharmaceuticals. We improve the lives of millions of people around the world with our exceptional products. And new, innovative medicines are on the way. We bring products to the people who need them around the world.

 

Location:

Upstate New York

 

Reports To:

Director of Toxicology

 

Salary:

95-146K Commensurate with experience.

 

Education:

Phd.

 

Requirements:

Training in Good Laboratory Practices, Drug Safety Evaluation Standard Operating Procedures, pharmaceutical industry or other aspects of toxicology studies. Experience in conducting toxicology studies. Good human relations and writing skills necessary. Ability to motivate and direct employees, understanding of Good Laboratory Practices and Standard Operating Procedures.

 

Duties:

The Toxicology Study Director will plan, direct, and interpret safety studies on new drug candidates taking overall responsibility for these studies in accordance with GLP and other regulatory guidelines. Duties include overseeing, coordinating, and participating in the preparation of technical regulatory documents relating to those studies. He/she will represent Drug Safety on project teams and facilitate communication of safety issues to and from project team members. Works with general supervision and need for consultation with management on day-to-day operations. 1. As GLP Study Director, plan direct and interpret short and long term toxicology studies in laboratory animals on new drug candidates. Serve as study team leader and ensure coordination of all parties contributing to study data (study team members) including Study Toxicologist, Study Supervisor, and Study Technician. Related responsibilities include: a. Prepare study designs for routine and special studies. Oversee the drafting of protocol outlines, study protocols, IACUC documents and other written materials consistent with the study designs approved by reviewing committees (e.g., PRC). b. Monitor the technical conduct of studies for adherence to protocol and for development of toxicologic effects. Report regularly to management on the progress of these studies. c. Direct the preparation of study reports, ensuring appropriate quality control procedures are used and effective and that schedule is maintained. Provide interpretation of results and integrate information provided by other groups (e.g., pathology and drug metabolism). 2. Perform similar oversight duties as Principal Investigator for studies directed by Drug Metabolism personnel. 3. Monitor designated studies at contract laboratories, serving as their principal liaison and communicating developments to Wyeth Research management, as appropriate. 4. Provide summaries of safety information for inclusion in submissions to regulatory agencies, assuring accuracy and readability within format guidelines. Work closely with document preparation staff to review and edit the overall documents and to integrate contributions from other groups (e.g., reproductive toxicology, drug metabolism). 5. Represent Drug Safety on multi-disciplinary project teams. 6. Participate in Drug Safety and Metabolism Protocol Review Committee, Project Review and other meetings involving multi-disciplinary review of drug safety data and department policy. Prepare and update SOPs. 7. Keep abreast of major developments in drug safety, recommending implementation of appropriate methods or acquisition of appropriate instrumentation.

 

Date Posted:

6/17/2008

 

Job ID:

1629

 

Company:

We are a clinical stage specialty pharmaceutical company. Our focus is on the treatment and prevention of disorders related to Vitamin D insufficiency. We have a portfolio of therapeutics with lower development risk for the indications of Vitamin D deficiency and for secondary hyperparathyroidism (SHPT) associated with chronic kidney disease (CKD). Our products address significant unmet medical needs with a target market that is expected to grow extensively.

 

Location:

Illinois

 

Reports To:

VP Regulatory and Clinical

 

Salary:

120-160k Commensurate with experience.

 

Education:

BS in biological or chemical sciences; advanced degree is preferred .

 

Requirements:

5-10 years pharmaceutical industry clinical development experience including support of product approvals and renewals and postmarketing activities, interacting with principle investigators and key opinion leaders. In-depth experience with clinical trial methodology, cGCPs per FDA and ICH guidelines, strategic clinical trial planning and operation, and comprehensive planning and management of project budgets. At least 2 years people and project management experience with strong interpersonal skills and proficiency in verbal and presentation capabilities. Ability to work independently and as a functional leader and participant in teams. Knowledge of biostatistics and data management would be a plus. Approximately 20% travel.

 

Duties:

Key Responsibilities: Contribute in proactively formulating global clinical development strategies that successfully execute Company’s core business of pharmaceutical development. Prepare clinical development timelines and budgets within multidisciplinary project teams to ensure timely submissions aligned with Company objectives. Coordinate, facilitate and construct study designs and protocols, appropriate study monitoring and conduct within cGCPs and consistent with the requirements for regulatory filings. Develop, interact with, and manage internal employees and external CROs and CMOs to assure timely and cGCP compliant activities to achieve clinical project successes to achieve corporate development plans. Participate in regulatory submission process, including INDs, CTAs, CTDs, NDAs and provide appropriate clinical updates to those documents. Ensure that all documents to be submitted to regulatory agencies are complete, scientifically accurate, well-organized and of high quality in such a way as to facilitate review. Serve as the principal spokesperson for clinical development and communicate to senior management of clinical development status. Build and maintain good business and working relationships with internal and external groups. Participate in the selection and maintenance of study investigators and clinical sites. Participate in analysis and review of data, and review, edit and contribute to the construction of clinical documents (study protocols and reports, informed consent and case report forms, publications) to ensure cGCP compliance and accurate presentation of data. Communicate openly and effectively, working to develop team-based approach and to lead and to motivate regulatory and compliance activities. Assist senior management to formulate and to establish company policies and operating procedures (SOPs) and ensure that staff attains a level of quality applicable to the Quality System and applicable professional standards. Coordinate and implement the requisite training and development of Clinical Development staff. Provide strategic leadership to identify potential difficulties and strategic execution to implement creative approaches to surmount challenges. Participate in activities related to potential inlicensing and outlicensing of products.

 

Date Posted:

6/17/2008

 

Job ID:

1628

 

Company:

We are a clinical stage specialty pharmaceutical company. Our focus is on the treatment and prevention of disorders related to Vitamin D insufficiency. We have a portfolio of therapeutics with lower development risk for the indications of Vitamin D deficiency and for secondary hyperparathyroidism (SHPT) associated with chronic kidney disease (CKD). Our products address significant unmet medical needs with a target market that is expected to grow extensively.

 

Location:

Illinois

 

Reports To:

VP Regulatory and Clinical

 

Salary:

120-160k Commensurate with experience.

 

Education:

BS in biological or chemical sciences; advanced degree is preferred.

 

Requirements:

5-10 years pharmaceutical industry regulatory experience including regulatory submissions to support product approvals and renewals, and post-marketing strategies and commercial awareness. At least 2 years people and project management experience with strong interpersonal skills and proficiency in verbal and presentation capabilities. Ability to work independently and as a functional leader and participant in teams. Knowledge of Quality Management Systems would be a plus. Approximately 20% travel.

 

Duties:

Summary: The Director or Senior Director, Regulatory Affairs is a tactical and leadership position that reports to the Vice President of Clinical and Regulatory Affairs and is responsible for devising and implementing regulatory strategies for late stage development and post-approval products. The position responsibilities also include serving as a secondary liaison with regulatory agencies regarding quality systems and compliance policies and will be located in the new Chicago office. It is designed not only as a supervisory position but would be expected to evolve to that position as the company advances development and commercialization of its leading compounds. Thus, the ideal candidate would have management and mentoring experience and would be expected to inspire and motivate, and to serve as a role model for reports and colleagues. Contribute in pro-actively formulating global regulatory strategies that interpret and reflect regulatory and corporate guidelines Plan, manage and implement regulatory programs into multidisciplinary project teams for all products from late-stage development through commercialization. Represent Company at FDA, DDMAC and other regulatory agencies. Initiate and respond to regulatory agency contacts (e.g. telephone, email, written, meetings) to negotiate successfully with regulatory agencies to achieve business objectives. Responsible and accountable for regulatory review of promotional materials and for ensuring regulatory compliance of product brand. Review global product promotional materials and press releases. Ensure that all documents to be submitted to regulatory agencies are complete, scientifically accurate, well-organized and of high quality in such a way as to facilitate review. Assist with the technical transition from pre-approval research to post-approval commercial phase. Assure compliance with all agency regulated late-stage development and post-approval activities including timely and accurate submissions of annual reports and supplemental filings. Assure that all regulatory and quality related activities and functions are current, are implemented fully and are compliant with defined standards, and that company personnel are trained appropriately. Build and maintain good business and working relationships with internal and external groups. Communicate to senior management of regulatory status and risks related to products and compliance. Work with internal departments and external CROs and CMOs to assure timely and cGXP compliant disposition of products. Communicate openly and effectively, working to develop team-based approach and to lead and to motivate regulatory and compliance activities. Interface directly with regulatory agencies to host regulatory inspections. Provide guidance on system validations tasks and product release. Assist senior management to formulate and to establish company policies and operating procedures (SOPs). Participate in activities related to potential inlicensing and outlicensing of products.

 

Date Posted:

6/2/2008

 

Job ID:

1625

 

Company:

We are a specialty pharmaceutical company that provides contract R&D, manufacturing and analytical services to the pharmaceutical industry. As a pharmaceutical contract service provider, We are continually increasing the scope of the contract services we provide to meet the growing needs of our valued client partners. We can offer the full spectrum of pharmaceutical contract services from development to complete commercial toll manufacturing and analytical testing.

 

Location:

Texas

 

Reports To:

Director of Quality Assurance

 

Salary:

65-100K

 

Education:

Minimum of a Bachelor’s Degree in Chemistry, Pharmacy or other Life Science.

 

Requirements:

5 plus years experience in QA/QC function within the US pharmaceutical industry. Has an excellent understanding of the world-wide regulatory framework within which the pharmaceutical industry operates. Works independently with limited supervision. Independent, tactical and strategic thinker. Logical, structured thinking leading to decisions based on deductive and inductive reasoning utilizing available data. Ability to give unbiased assessment. Ability to make realistic evaluations especially during the development phase. Capacity to analyze complex systems. Solid leadership skills. Exhibits empathy and respect for others. Proven management skills when working with high energy motivated multi-discipline teams. Has excellent verbal, written and presentation skills.

 

Duties:

The Associate Director of QA works with the Director of Quality Assurance and establishes and manages systems to assure compliance with US, EU and world-wide regulatory guidelines for all relevant operations carried out within and for Company. The position is responsible for the continuous assurance of the quality of products. This function includes: Assuring that all regulatory requirements are met and maintained current. Managing Regulatory submissions, filings and updates - including INDs, NDAs, ANDAs- to be on time, complete, and according to agency expectations.

 

Date Posted:

6/2/2008

 

Job ID:

1624

 

Company:

We are a specialty pharmaceutical company that provides contract R&D, manufacturing and analytical services to the pharmaceutical industry. As a pharmaceutical contract service provider, We are continually increasing the scope of the contract services we provide to meet the growing needs of our valued client partners. We can offer the full spectrum of pharmaceutical contract services from development to complete commercial toll manufacturing and analytical testing.

 

Location:

Texas

 

Reports To:

Senior Director of Operations and/or the COO

 

Salary:

100-130K

 

Education:

BS or MS in chemistry or equivalent science.

 

Requirements:

6-10 years of work experience working in chemistry, quality control and/or laboratory management positions; Extensive experience of and working with GMPs/GLPs. Internal contact: Daily contact with personnel from all departments of Company; Regular contact with management. External contact: Frequent contact with clients; Primary laboratory contact with FDA personnel; Primary company contact with other regulatory bodies. Direct supervision of laboratory groups – manufacturing support, stability, method transfer, laboratory services.

 

Duties:

The Director of Quality Control is ultimately responsible for managing personnel working in the area of Quality Control and their respective actions and projects. Responsibilities include the daily execution of activities as assigned, but not limited to, the following: Manage the quality control group for release and stability testing of finished products, in process testing, QC inspections and audits, QC documentation, equipment maintenance and calibration and QC laboratory design and maintenance. Manage the general quality control aspects of Company analytical laboratory, including conducting investigations and non-conforming events, ensuring adequate training and monitor training effectiveness for lab personnel. Manage and oversee daily laboratory activities and quality control chemists. Establish and manage quality control group for raw material testing (i.e. APIs, excipients, packaging components). Perform regularly internal lab audits to ensure GMP compliances. Participate in audits from outside companies and FDA. Coordinate with QA for QC data review, addressing comments from QA and/or clients, and ensuring the proper calibrations, qualifications, and preventive maintenance of lab instruments. Coordinate with manufacturing for weekly scheduling of testing. Coordinate with R&D group for transfer, qualification and validation of test methods into QC. Prepare, review and/or approve Standard Operating Procedures, technical reports, specifications, stability protocols, and QC analytical test records. Maintain the stability programs and stability sample reconciliations.

 

Date Posted:

5/29/2008

 

Job ID:

1623

 

Company:

We an early clinical research clinic. Mainly focusing on Phase 1 and 2 clinical trials.

 

Location:

South Florida

 

Reports To:

President

 

Salary:

Salary, Bonus, Stock options.

 

Education:

 

Requirements:

Real go getter with steam. Candidate has worked at a unit in a pharma on Phase I Trials getting studies, protocols, giving meds, following up with drawn blood etc. Connections with phase I mandatory.

 

Duties:

Create a level of business that can be drawn from the pharma companies in the States.

 

Date Posted:

5/20/2008

 

Job ID:

1620

 

Company:

We are a worldwide specific pharmaceutical and medicine delivery company devoted to improving health by developing, manufacturing and marketing products that help improve the productivity, protection and effectiveness of patient care. We recently acquired another Pharma company to become the global leader in special injectable pharmaceuticals that happen to be generic. With over 7 decades of service to the hospital industry, Our portfolio includes one of the industry's extensive lines of injectables, solutions for medicine management. As well as infusion therapy. We are also a primary provider of contract manufacturing services to proprietary pharmaceutical and biotechnology companies. Our extensive portfolio of products is used by hospitals and other site providers, such as clinics, home health care providers and long-term care facilities.

 

Location:

Illinois

 

Reports To:

Director of Pre-Clinical Development

 

Salary:

100-125K

 

Education:

Ph.D. or D.Sc.

 

Requirements:

Relevant on-the-job experience is required to lead senior technical staff in complex toxicology and related programs. Minimum of 6 years, preferably more, of industrial and/or contract research laboratory experience with a proven record of leading a tem of scientists through all stages of toxicology development. Strong interpersonal and communication skills in order to lead scientific staff and cross-functional activities. Board certification in toxicology is highly desirable. Knowledge of regulatory requirements/guidelines with broad technical knowledge to review scientific reports for regulatory submissions. Excellent verbal and written communication skills. Ability to lead multidisciplinary teams and maintain project schedules on multiple programs.

 

Duties:

In this role you will provide technical leadership for the toxicology development of small molecules and complex biotechnology-derived and biological products. You will provide leadership for cross-functional activities necessary to assure achievement of area goals and advance the scientific capabilities of the department through the selection and training of staff. Other responsibilities: Lead R&D function within multiple projects and maintain regular communication with senior management. Identify, plan and coordinate R & D and cross-functional activities to ensure completion according to project plan and milestone. Maintain active involvement in external professional organization. Insure the integrity of documents to meet technical and compliance standards. Assess and implement new technologies and drive to establish intellectual property and scientific publications.

 

Date Posted:

5/2/2008

 

Job ID:

1618

 

Company:

We are a worldwide pharmaceutical and healthcare company. We develop, manufacture and market prescription pharmaceuticals. We offer an extensive array of medicines made to fight disease. We concentrate our resources on six therapy areas where we feel we can make the most difference. Our extensive product portfolio is targeted at these important areas and includes numerous global leaders and a number of key products.

 

Location:

UK and Sweden

 

Reports To:

Early Development Director

 

Salary:

£120,000 pa plus 20-30% bonus or in US Currency Up to $250K

 

Education:

M.D. Ideally backed up by PhD and/or research experience capable of impacting novel target discovery

 

Requirements:

Demonstrated clinical research expertise. Specialty training or board eligibility within the therapeutic area of Respiratory. Min 5 yrs. demonstrated cross-functional leadership experience within academia and ideally within industry. Extensive Drug Development Experience (> 5 years). Proven teamwork and collaboration across diverse skill sets. Ability to travel nationally and internationally. Preferred Background: 10 yrs. demonstrated success in clinical leadership positions. Successful track record in drug development, regulatory and external interactions. Experience in several organizations and geographic locations. Internal and External Contacts/Customers: Strong worldwide external awareness, good scientific and external decision-maker-networks. Regulatory and Academic Network. Credible in medical, scientific and commercial environments.

 

Duties:

Description: The Medical Science Director will deliver to the RA/TA in collaboration with Discovery & Clinical the Medical Scientific strategies for clinical components of Target Identification (TI), Target Validation (TV), Disease Area Knowledge, patient segmentation, patient stratification, personalised medicine, exploratory development clinical studies and strategies for prioritised targets, between Pre-projects and MS3. Within the Clinical Discovery Team (CDT) the Medical Science Director is the Clinical Team Leader and has accountability for the overall clinical, scientific, value content & delivery of the Medical Science components to the RA/TA and Clinical Organization. Major Responsibilities: Accountabilities: RAMT & Discovery Bodies, specifically Target Selection Committees-Input into Pre-project, MS1-MS3 & prioritisation of this portfolio. TAPT & DAST-Input into DAS & TAPT strategy. Translational Medicine Leadership Team-Provide discovery and clinical resource, support, technology access for biomarkers, imaging, safety etc TA Clinical Leadership (EDD and TACVP)-Provide Input into clinical resource requirements and budget. Clinical Project Team-Overall clinical, scientific & value content. Delivery of Medical Science components to the CDT to time & quality. Responsibilities: Responsible for the Translational Medicine Plan for Emerging Targets entering MS1 portfolio. Responsible for the clinical strategy that new targets will meet future TPP/TPC and target labelling. Responsible for the clinical documents to support MS1 transitions and any clinical documents required for the TSC. Responsible for the ethical and scientific integrity of the plans and clinical studies. Responsible with Drug safety for the risk management plan and evaluation of new targets. High level strategic external interactions including academic collaborations & key external centres required for development activities and support for the MS1-MS3 portfolio. Together with Project Co-ordination Director, support rapid implementation of agreed and budgeted plans through the CDT. Ensure project clinical strategies and plans receive peer review (TMLT) to assure quality. Support as appropriate within project during issue & crisis management as directed by EDD & VP, Clinical for TA.

 

Date Posted:

5/2/2008

 

Job ID:

1617

 

Company:

We are a worldwide pharmaceutical and healthcare company. We develop, manufacture and market prescription pharmaceuticals. We offer an extensive array of medicines made to fight disease. We concentrate our resources on six therapy areas where we feel we can make the most difference. Our extensive product portfolio is targeted at these important areas and includes numerous global leaders and a number of key products.

 

Location:

UK and Sweden

 

Reports To:

Early or Late Phase Development Director

 

Salary:

£120,000 pa plus 20-30% bonus or in US Currency Up to $250K

 

Education:

M.D.

 

Requirements:

Minimum Requirements Graduate of a recognized school of medicine with an M.D. degree or equivalent. Demonstrated clinical research expertise in Respiratory. Specialty training and board eligibility in Respiratory preferred. 5 yrs. demonstrated leadership experience. Extensive Drug Development Experience. Proven teamwork and collaboration skills. Ability to travel nationally and internationally. Preferred Background: Board certification or eligibility in (name specialty areas). 10 yrs. demonstrated leadership experience. Experience in several organizations and geographic locations. •Internal and External Contacts/Customers: Strong worldwide external awareness, good scientific and external decision-maker-networks. Regulatory and Pricing/value awareness. Credible in scientific and commercial environments.

 

Duties:

Description: The Medical Science Director will deliver to the GPT the Medical Scientific strategies for clinical components of the TPP, TPC, CDP, and core labeling texts and to provide medical input into commercial activities and the scientific component of the pricing & value strategy Within the Clinical Project Team the Medical Science Director has accountability for the overall clinical, scientific & value content and delivery of the Medical Science components to the project to time & quality. In some cases, the MSD may be appointed the CPT leader. The CPT leader role is as follows: In addition to the other aspects of the MSD role, the CPT Leader is responsible for setting up the team, defining the structure within the principles of the CPOM, and for ensuring that the team develops into an effective functioning unit while demonstrating competence against the Company Leadership Capabilities. The CPT Leader is required to be skilled in creating a productive and motivational team climate and in driving performance in order to achieve individual, team and organizational objectives. The CPT Leader is also required to be skilled in decision-making, and in ensuring that the delivery teams are appropriately empowered and are able to make decisions effectively. The CPT Leader provides the vision and direction for the team, and ensures that all parts of the wider clinical team have clear goals, charters and objectives. The CPT Leader maintains a high level view of the whole clinical program and takes overall accountability for it. The CPT Leader also ensures that team performance is appropriately recognized. Major Responsibilities: Accountabilities: Global Product Team, –Timely provision of Medical Scientific strategies for clinical components of the TPP, TPC, CDP, and core labeling texts. –Medical input into commercial activities. –Timely provision of scientific component of the pricing & value strategy. Accountable for the benefit risk assessment. Additional accountabilities when MSD is Clinical Project Team Leader:Provision of provides direct leadership to members of the CPT, and is accountable for all aspects of team formation and development of the team (see description above). Clinical Project Team: Overall clinical, scientific & value content. Delivery of Medical Science components to the project to time & quality. Responsibilities: •Responsible for the clinical strategy to meet TPP/TPC and target labelling. Responsible for the ethical and scientific integrity of the plans, studies and the product. Responsible with Drug safety for the risk management plan. High level strategic internal and external interactions including (Academic collaborations and Key Opinion Leader & key centres development and support). Together with Project Co-ordination Director, support rapid implementation of new processes & systems through their project. Ensure project clinical strategies and plans receive peer review to assure quality. Support as appropriate within project during issue & crisis management as directed by Early or Late Phase development Director.

 

Date Posted:

4/24/2008

 

Job ID:

1616

 

Company:

We design, manufacture and commercialize Remote Robotic systems for percutaneous applications. Our product enables the physician to perform catheterization procedures from a distant location away from the radiation zone. Our product mechanically moves devices through patients’ arteries as directed by the physician at a remote workstation. It is designed to work well with high-tech cardiology products.

 

Location:

Boston, MA

 

Reports To:

Co-Founder & COO

 

Salary:

Commensurate with experience at fair market.

 

Education:

MS/PhD/MD preferred in a scientific discipline (i.e., medical/scientific field, biological science, RN with significant experience).

 

Requirements:

Must be a hands-on type who knows the cardiovascular field. Candidate will be the only person in this department in the first year. 8-12 years clinical research or regulatory experience with Class II or III medical devices. Experience in designing, executing, analyzing, and presenting the results of medical device clinical trials. Experience interacting with domestic and international regulatory authorities. Strong knowledge of good clinical practice (GCP) and regulatory compliance guidelines. Proficient in running multi-site clinical studies (domestic and international). 2-5 years in Cardiology. working knowledge of anatomy, disease states, Cath Lab interventional procedures. Skill in managing multiple fast-paced and high-demand projects, successfully balancing scope, schedule, and cost. Outstanding verbal and written communication skills to interact successfully with physicians, service providers, and senior management and staff. Must be adept at delegation, follow-up, and team building. Able to travel up to 30%. Missing in many candidates I have seen: 1-A person on their way up, not a settled person who is already in this position for a long time and does not have the "flame" in their eyes and therefore they are usually less hands-on people. 2- Cath lab experience and/or the clinical affairs management.

 

Duties:

POSITION SUMMARY: Responsible for all international and domestic clinical and regulatory activities for our system. Initial responsibilities will be focused on executing 510(k) approval in the US and CE mark in Europe. RESPONSIBILITIES: Strategic planning: Along with senior management team, sets direction for clinical studies and regulatory filings, defines objectives and outputs; and determines the cost, schedule, priority to accomplish objectives. Project management: For each regulatory filing or Clinical trial, assures that its planning and execution is managed effectively and efficiently, on schedule, and within budget. Oversees compliance of Sponsor/Investigator/Monitor responsibilities to protocol, case report forms completion, and ICH GCP guidelines. Regulatory Management: Write, review and handle all regulatory submissions of the company. For each filing assure that it executed on time and within the budget. Initially responsible for writing and submission the CE Mark and IDE submissions of the company. Relationship management: Along with senior management team, establishes and manages positive relationships with key clinical investigators, clinical research contract service providers, medical institutions, leaders of medical conventions, professional societies, etc. Department management: Build and lead a small but dynamic staff to execute Clinical and Regulatory objectives. Clinical trial management: lead the company activities in these fields towards a CE and FDA approval.

 

Date Posted:

4/10/2008

 

Job ID:

1615

 

Company:

Company is a healthcare services management company formed for the purpose of researching, developing, licensing, and commercializing innovative technology to improve the treatment of alcoholism and drug addiction. Our proprietary, patented and patent-pending treatment protocols are intended for use in treating addiction by stabilizing neurological function. The first step of treatment typically requires detoxification from the addictive substance prior to the initiation of psychological therapy. Traditional detoxification therapies generally consist of 5-14 days of combined inpatient treatment and washout period, use sedatives which expose the patient to the risk of dependence to those drugs, frequently require a tapering and washout period, and do not reduce or eliminate craving. While treating the psychological component of addiction is important, Company recognizes that physiological factors of addiction need to be addressed first to provide patients the best chance for recovery. Unlike current practices for withdrawing addicted patients from alcohol, cocaine, or other addictive stimulants, treatment using the Company protocols is intended to eliminate the use of sedating medications, reduce inpatient treatment time, require no tapering or washout period, and have substantially higher completion rates. Company protocols are specifically designed to reduce or eliminate cravings, a major factor in relapse. We believe this physiological approach to addiction prior to psychological therapy offers patients an improved chance for a complete and persistent recovery. Company provides the treatment community with the most comprehensive approach to the treatment of addictions. Through a combination of medication and nutrients, Company Treatment Protocols specify the use of revolutionary new methods to target the neurotransmitters and receptors most influenced by alcoholism and other drug addictions. When prescribed and supervised by a medical professional, the Company Treatment Protocol is intended for neurostabilization and detoxification from alcohol and/or addictive stimulants while simultaneously reducing or eliminating cravings, enhancing cognitive function, and facilitating the withdrawal process, resulting in accelerated recovery. Impulse control may also be improved, the patient may not be as irritable, and may handle social situations more effectively. The Company Treatment Protocols are for use in treating alcohol and stimulant addiction at the source — the brain. The goal of this medically supervised treatment designed to regulate brain function over the course of 2-3 days is a patient who is detoxified and able to concentrate on recovery without the recurrent cravings believed to be the main cause of relapse..........technology, alcoholism, drug addiction, neurological, detoxification, addictive substance, psychological therapy, sedatives, alcohol, cocaine, addictive stimulants, sedating medications, nutrients, neurostabilization, neuron adaptation, opiate, The HANDS Patient Protocol(TM), endogenous brain chemicals, GABA, dopamine, glutamate, serotonin, alcoholism and drug addiction, substance abuse, addiction.

 

Location:

Southern CA

 

Reports To:

Chairman

 

Salary:

Cash & Option package

 

Education:

Commensurate

 

Requirements:

The ideal candidate will have a thorough understanding of how value is created in the biomedical industry, a track record of success in managing and growing a medical Service company and shepherding its product candidates from the late clinical stage to a successful outcome and in negotiating product partnering/sale arrangements employing a variety of approaches. Public pharmaceutical company experience and experience with mergers, acquisitions, licensing and financing would be valuable.

 

Duties:

Meets in person 4 times a year, with conference call meetings once a month. Public Experience Pharma or Devices Able to be involved with Proxy Statement.

 

Date Posted:

4/3/2008

 

Job ID:

1614

 

Company:

We are a biotechnology company aimed on the discovery and research of innovative products for critical care. Whose main focus is to address the needs of critically ill patients by developing and commercializing novel treatments. Our proficiency is in developing and commercializing drugs and novel treatments for the critically ill. We are at the beginning of a new research area in metabolic depression, the company is swiftly engaged in the development of products that may change critical care medicine.

 

Location:

WA

 

Reports To:

Director of Pharmacology.

 

Salary:

100-110K

 

Education:

PhD in physiology, pharmacology, biology, chemistry, or pharmacy.

 

Requirements:

5+ years experience in biopharmaceutical environment. Previous experience supervising research technicians in the lab preferred. Broad experience in cardiovascular and pulmonary physiology. Established track record in conducting studies through external collaborations including managing all aspects of pre-clinical studies to final report stage and preparation of summary sections for inclusion in regulatory filings. Excellent organization skills required. Through knowledge of statistical methods and excellent oral and written communication skills.

 

Duties:

Candidate will be responsible for conducting efficacy studies in rodents to establish preliminary efficacy studies. In addition, the candidate is expected to plan and supervise external efficacy studies in large animal model of efficacy which take place at external facilities under sponsored research agreements with academic and contract facilities. This includes qualification of laboratories, planning and finalizing study design, supply of study drug, project management and report review. The candidate will participate in the generation of relevant sections of regulatory filings in the US and foreign territories. The candidate will also interact closely with in-house staff in chemistry, biochemistry and analytical staff as needed to ensure a progression of programs from research to early development.

 

Date Posted:

4/3/2008

 

Job ID:

1613

 

Company:

We are a biotechnology company aimed on the discovery and research of innovative products for critical care. Whose main focus is to address the needs of critically ill patients by developing and commercializing novel treatments. Our proficiency is in developing and commercializing drugs and novel treatments for the critically ill. We are at the beginning of a new research area in metabolic depression, the company is swiftly engaged in the development of products that may change critical care medicine.

 

Location:

WA

 

Reports To:

Director Biological Chemistry

 

Salary:

100-110K

 

Education:

PhD in analytical chemistry or related field.

 

Requirements:

Post doctoral experience and at least five years of pharmaceutical industry experience in analytical chemistry. Solid background in organic and inorganic chemistry. Documented experience in analytical methods development for small molecules by mass spectrometry (Triple Quad with ESI, APCI and HESI), HPLC (UV/VIS/fluorescence, electrochemical detectors, Corona CAD), and Ion chromatography. Experienced in quantifying small molecules and gases by GC with PDD or RGD. Experienced in the development of extraction methods for compounds from biological materials and use of derivatization techniques to modify small molecules. Experience in GLP methods development desirable. Demonstrated leadership and supervisory experience. Self-motivated and goal-oriented. Team player. Excellent verbal and written communication skills. Excellent time management, organizational and problem-solving skills. Must be authorized to work in the US.

 

Duties:

Lead analytical chemistry group. Develop analytical methods for Company’s small molecule drug candidates and their metabolites. Develop extraction methods for compounds from biological tissues. Analyze samples from PK/TK and ADME studies. Document methods and summarize results in reports. Manage analytical GLP studies at CRO’s. Train and supervise analytical personnel. Prepare study reports for inclusion in regulatory filings. Communicate findings and results to management. Make presentations within Ikaria as well as at external scientific meetings.

 

Date Posted:

3/10/2008

 

Job ID:

1608

 

Company:

We are leaders in developing novel measurement and control technologies in order to assist the transition to single-use systems, bring up-to-the-minute capabilities to existing bioreactor platforms, and complement worldwide bio-process information transfer. Our goal is to provide unequaled Measurement and Control solutions. We are continually developing and introducing products whose purpose is to provide our customers with solutions that deliver enhanced accuracy, reliability and quality. Our vision is to improve the productivity of our life science customers through novel measurement and control solutions that span both upstream and downstream bioprocesses................................measurement, control, technologies, single-use systems, bioreactor platforms, worldwide, bio-process, information transfer, life science, plug-and-play, complex, biotechnology, pharmaceutical, Sensors, Hardware, Software, optical sensors, research, production, software, hardware, analytical, tools.

 

Location:

Europe

 

Reports To:

VP Sales

 

Salary:

100K plus generous commission, A hard worker can expect to make over $200K

 

Education:

Minimum B.S. is Science or Engineering Discipline

 

Requirements:

Proven track record in selling instruments/analyzers to process industries. Minimum of 5 years experience in the biotech and pharmaceutical industries. Ability to manage both direct and indirect sales channels. Ability to travel throughout territory. Demonstrated proficiency with illustrations software and PowerPoint supported presentations. Ability to work independently and respond rapidly to changing market demands. Must have great communication skills and be able to present in front of small to medium size groups. Must have great time management and organizational skills and be self motivated to “run the business”. And most importantly, a smile on your face and a great attitude! Expected 25-50% overnight travel.

 

Duties:

Primary Duties and Responsibilities: Responsibility for achieving revenue targets in European territory. Responsible for developing and driving the European market segment. Responsible for achieving sales goals in the European market segment. Forecast manufacturing needs of European market segment. Primary contact for sales and support for end-users, representatives, distributors and OEMs in territory. Responsible for managing sales reps activities in this market segment. Development and training of indirect sales channels in territory. Develop and maintain relationships with key customers in market. Work with VP of Sales and marketing group in developing and implementing product training programs for reps, dealers and high profile users. This may include public event/clinics where market appropriate. Production of sales reports and forecasts as defined by VP of Sales. Secondary Duties and Responsibilities: Support of local trade shows and some national and international marketing events as necessary. Work with marketing group in developing and maintaining the advertising, trade show and printed promotional plans for product group. In conjunction with marketing, gather data and suggest products and promotions that will penetrate the market, gain market share and increase sales. Report market trends, competitive issues, and emerging opportunities to Director of Sales and Marketing. Report and define requested customer features and products to CTO. Development of applications under the supervision of CTO.

 

Date Posted:

3/1/2008

 

Job ID:

1605

 

Company:

Company has invented a diagnostic device. We are committed to creating affordable, easy to use diagnostic devices that enhance and quantify the traditional process of physical palpation for breast cancer screening. Company has a revolutionary product detecting Tumors in Breast without the Radiation, Pain and Humiliation. Our device is accurate and easily administered. At last, women of all ages across a broad socio-economic range can receive a level of care and critical screening that would be otherwise unavailable.

 

Location:

Southern CA

 

Reports To:

Board of Directors

 

Salary:

250K +equity

 

Education:

Successful past ....

 

Requirements:

The ideal candidate needs to have been at a start-up, preferably a medical device/drug company, and has to have brought that start-up from conception to an initial public offering (“IPO”). The candidate should possess extensive knowledge of the business processes involved in the development of a team of individuals to successfully commercialize the technology and deal with Wall Street during both pre and post IPO stages. A successful candidate may have also taken a company public and subsequently sold the company outright. A successful candidate’s interest should be in the value of the equity involved with this position, which could be very substantial.

 

Duties:

Build and lead a team to successfully commercialize the technology and concurrently take the company public.

 

Date Posted:

1/14/2008

 

Job ID:

1603

 

Company:

We are a leading biotechnology company primarily focused on the discovery, development and commercialization of quality pharmaceutical products, Our company endeavors to better the health and quality of life for patients, extend breakthrough treatment opportunities for physicians, propose rewarding careers to employees, and deliver worth to our shareholders. Our approach is to build on the victory of our groundbreaking product and continue to advance in clinical and pre-clinical drug candidates to supply longer-term growth. We have grown to become a scientifically powerful and financially thriving top-tier biopharmaceutical company that is centered on disease regions that affect virtually every family in the world. Indications for metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. Product is also approved for the first-line treatment of locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine (chemotherapy).

 

Location:

Colorado

 

Reports To:

Sr Dir Drug Safety

 

Salary:

175 -195k upto 22% bonus & restricted stock & options

 

Education:

M.D. degree is required

 

Requirements:

Board Certification and medical specialty and a minimum of 2-4 years in clinical practice in relevant setting are preferred. - Experience in drug safety/pharmacovigilance and familiarity with regulatory guidelines and requirements is highly desired. Candidate should have experience in or knowledge about drug-development procedures. Internal medicine background. Superior verbal and written communication skills.

 

Duties:

Provide medical assessment of incoming adverse event information for all our products. This includes but is not limited to assessment of possible causality, seriousness, labeledness/expectedness, and regulatory reportability. Perform review of adverse event coding for individual safety cases and aggregate information from clinical trials. Additional responsibility includes ongoing evaluation of potential new safety signals for company products and work proactively to ensure proper communication of relevant findings. The responsibilities cover both products pre- and post approval activities. Write overall safety evaluation for aggregate safety reports including PSURs, PSRs, and clinical study annual reports. Assess developing safety information, anticipates potential impact, communicate implications and develop strategies for clinical and regulatory issues. Knowledgeable about regulatory requirements pertaining to drug safety/pharmacovigilance as well as knowledge in the use of MedDRA. Coming from either Internal medicine and or oncology as well as from the clin research and drug safety obesity & diabetes side would be spot on . dealings with Oxford .........internallizing with England .........

 

Date Posted:

12/19/2007

 

Job ID:

1593

 

Company:

We are a primary provider of software, calculated consulting, and regulatory services for performing clinical pharmacology development. Our database Server for the storage, management, analysis, and regulatory reporting of derivative data and models in data repositories for efficient on-site validation; and Drug Model for vibrant visualization and communication of sample-based product profiles. Our company develops and markets integrated products and services that allow pharmaceutical and biotechnology companies to attain major and lasting improvements in the development and use of therapeutic products. Company strives to help customers reduce the time, cost and risk of drug development. We enhance drug development decision-making and efficiency through our services.

 

Location:

Northern CA or NC

 

Reports To:

CEO

 

Salary:

195 to 230k

 

Education:

MBA required; B.S. degree in a Life Science field a plus

 

Requirements:

Ideal candidate has 20 years of work experience of which the last 4-6 years should be in a senior management position in a pharmaceutical services business or as a Principal/Partner in a leading consulting firm, preferably focused in the life sciences industry. Knowledge of overall engagement and project management with broad experience at the executive level supporting business operations. Experience in training and coaching a World Class consulting/services workforce. Excellent leadership and communication skills with strong understanding of the life science industry preferred. Ability to quickly understand and assimilate practice cultures and be a change agent where necessary. Ability to coach VP-level scientists and assist them in mentoring and development activities of their scientific practices. Dynamic skills in navigating internal company operations and practices and ensuring teams are using processes and systems to support business effectiveness. Ability to proactively reach out to current and future clients on business opportunities and partnerships and engage others in practices to support activities. Collaborative partner who is capable of working with peers and senior client leadership to foster an organization with World Class standard operating practices, cost measures, and reporting systems. Ability to focus improvement initiatives in support of corporate strategic goals. Ability to assess competitive business landscape and engage practices in outward practice development activities. Travel Required: 20-40%

 

Duties:

Key executive management position providing leadership for consulting services business. Responsible for the strategic vision of the consulting services business with a focus on its revenue growth and efficient operations. Propel practices forward by ensuring that engagements are well managed, business development is robust and best practices are being developed. Drives cohesiveness of Strategic Consulting Services practice and Reporting and Analysis Services practice and partners with other departments to achieve business success. Essential Job Functions: Oversees scientific Vice Presidents and key clients to facilitate development of current and future business opportunities. Advises and directs practice development activities to ensure people are engaged internally in coaching and mentoring opportunities as well as public-facing activities. Ensures that engagement management, budgeting, risk and project economics are supporting overall business unit strategies. Participates effectively with scientific Vice Presidents in the identification and development of new practice areas. Collaborates with the CEO, SVP Sales and SVP Marketing to formalize and administer marketing activities that will drive business growth. Identifies and disseminates company-wide “best practices” and standards within the Consulting business units. Fosters and maintains engagement activities and programs to support an employer of choice environment in the scientific community. Business unit P&L responsibility. Some candidates may know one specific therapeutic area very well ( cancer, diabetes, etc.) and advise pharma/biotech companies on that area. However, they may be too focused for us since our scientific consulting services cover many areas - generalists are better here. Also, the above may lack some clinical development experience, but has more experience on the commercialization side. A balance of both is preferable Strength in operations is fine, and adds to the profile, however the focus is on driving growth of the practice - demonstration in managing a group of scientists/services and pushing through the marketplace is more valuable (we have a VP of operations for this group already) commitment/interest in modeling and simulation, especially those with CROs. Some may view this role as a step down, sideways or up, depending on the size of their organization and their orientation. Also, their market focus could be very wide, while ours is narrower. While were trying to sell our services to the head of pharmacology at a drug maker, it would be great to have someone the level up (VP of Clinical Development) as a candidate, who would have a unique perspective of the marketplace for services.

 

Date Posted:

12/19/2007

 

Job ID:

1592

 

Company:

We are a primary provider of software, calculated consulting, and regulatory services for performing clinical pharmacology development. Our database Server for the storage, management, analysis, and regulatory reporting of derivative data and models in data repositories for efficient on-site validation; and Drug Model for vibrant visualization and communication of sample-based product profiles. Our company develops and markets integrated products and services that allow pharmaceutical and biotechnology companies to attain major and lasting improvements in the development and use of therapeutic products. Company strives to help customers reduce the time, cost and risk of drug development. We enhance drug development decision-making and efficiency through our services.

 

Location:

North Carolina or the BAY AREA -CA

 

Reports To:

CEO

 

Salary:

180-225k

 

Education:

MBA (with technical B.S.) or M.S.

 

Requirements:

15 years of experience in product management. At least 10 years of experience managing a product management team and a departmental budget. Knowledge of the software development life cycle, preferably in life sciences. Experience with products targeted at the pharmaceutical industry. Experience in successful leadership of new product definition, release and deployment in the market. Experience in strategically partnering with clients to enhance current products and/or release a new products. Ability to create and maintain successful internal and external relationships by way of superior communication skills. Finely-tuned team management skills in coaching and development as well as recruitment and selection of product marketing professionals. Excellent presentation skills that are effective with internal and external audiences. Ability to manage a product management team to ensure technical knowledge is translated to product strategic vision from conception to market. Ability to deeply understand market and client needs and facilitate acceptance and engagement of internal stakeholders to enable driving products to market. Ability to manage and oversee a product management team as they work through technical issues, development roadmaps and product release requirements that impact product releases. Ability to maintain a strong external market big-picture vision for both product and company strategy, finding innovative solutions for a broader market and understanding internal resources. Travel Required: 20-30%.

 

Duties:

The VP, Product Management will be responsible for directing and overseeing a “world class software product management team” responsible for the execution of the strategic vision for all software products. As the overall evangelist for the product offerings, this position will ensure the product management team is partnering effectively internally with sales, marketing and engineering teams to support market definition, competitive analysis, product business plans, product specifications and product strategy. They will ensure that current and future product strategy and releases support corporate revenue growth and market share objectives. Essential Job Functions: Oversees the product life cycles including: strategic planning, market requirement identification, product specification development, release planning and execution and on-going product management. Ensures that strategic product plans are implemented by product management, sales and development teams effectively. Oversees product management team in their efforts to generate market research, monitor competitive activity, identifying customer needs and establishing pricing strategies. Fosters strategic relationships between clients and product management team. Manages product management team in best practice methods of recruiting, development and mentoring. Ensures the product management discipline is effectively working with other teams internally and is highly regarded by the external market and clients. Adds expertise, strategic vision and solutions as a member of the executive management team. Manages departmental budgetary expenses.

 

Date Posted:

8/27/2007

 

Job ID:

1562

 

Company:

Company is a healthcare services management company formed for the purpose of researching, developing, licensing, and commercializing innovative technology to improve the treatment of alcoholism and drug addiction. Our proprietary, patented and patent-pending treatment protocols are intended for use in treating addiction by stabilizing neurological function. The first step of treatment typically requires detoxification from the addictive substance prior to the initiation of psychological therapy. Traditional detoxification therapies generally consist of 5-14 days of combined inpatient treatment and washout period, use sedatives which expose the patient to the risk of dependence to those drugs, frequently require a tapering and washout period, and do not reduce or eliminate craving. While treating the psychological component of addiction is important, Company recognizes that physiological factors of addiction need to be addressed first to provide patients the best chance for recovery. Unlike current practices for withdrawing addicted patients from alcohol, cocaine, or other addictive stimulants, treatment using the Company protocols is intended to eliminate the use of sedating medications, reduce inpatient treatment time, require no tapering or washout period, and have substantially higher completion rates. Company protocols are specifically designed to reduce or eliminate cravings, a major factor in relapse. We believe this physiological approach to addiction prior to psychological therapy offers patients an improved chance for a complete and persistent recovery. Company provides the treatment community with the most comprehensive approach to the treatment of addictions. Through a combination of medication and nutrients, Company Treatment Protocols specify the use of revolutionary new methods to target the neurotransmitters and receptors most influenced by alcoholism and other drug addictions. When prescribed and supervised by a medical professional, the Company Treatment Protocol is intended for neurostabilization and detoxification from alcohol and/or addictive stimulants while simultaneously reducing or eliminating cravings, enhancing cognitive function, and facilitating the withdrawal process, resulting in accelerated recovery. Impulse control may also be improved, the patient may not be as irritable, and may handle social situations more effectively. The Company Treatment Protocols are for use in treating alcohol and stimulant addiction at the source — the brain. The goal of this medically supervised treatment designed to regulate brain function over the course of 2-3 days is a patient who is detoxified and able to concentrate on recovery without the recurrent cravings believed to be the main cause of relapse..........technology, alcoholism, drug addiction, neurological, detoxification, addictive substance, psychological therapy, sedatives, alcohol, cocaine, addictive stimulants, sedating medications, nutrients, neurostabilization, neuron adaptation, opiate, The HANDS Patient Protocol(TM), endogenous brain chemicals, GABA, dopamine, glutamate, serotonin, alcoholism and drug addiction, substance abuse, addiction.

 

Location:

Southern CA

 

Reports To:

Senior Executive Vice President

 

Salary:

200 – 250k range, large equity piece

 

Education:

MD or a Ph.D.

 

Requirements:

Strong background in clinical trials management and strong clinical research ties to the academic/scientific world. Additionally, the incumbent will have a solidly rooted background in CNS, specific addiction research or clinical experience is a significant plus. An ability to build relationships within government entities, pharmaceutical companies, academics and insurance/managed care companies will also be very important. Experience with managing clinical trials and a demonstrated knowledge base in clinical affairs will also be critical. The leading candidate should also exhibit an entrepreneurial spirit and the ability to think outside the box along with a willingness to lead people and programs. The person should also have superior project management skills while being able to be a scientific strategist.

 

Duties:

Position Summary: The Senior Vice President will be responsible for the design, planning, implementation and reporting out of all clinical research projects within and on behalf of the Compa ny. Direct aspects of this will include liaison responsibilities with thought leader, key opinion leaders and leading clinical academics and advocates outside of the Company where these relationships will range from CRO’s, and other vendor providers as well as affiliated hospitals and research institutions. This leader will also serve as an internal thought leader and leading scientific spokesperson for the Company relative to scientific and clinical information and inquiries regarding the program. Additionally, the SVP, Scientific Affairs will also be responsible for providing leadership relative to animal study research and resources through similar types of outside entities. This would require that the incumbent be connected to and knowledgeable as to available literature, papers/presentations and resources that continue to support early stage research work on the Company’s behalf. Finally, the SVP will also play a critical role in the investigation and development surrounding new program platforms and business entities that would fall under the Company’s focus on behavioral dependency management issues. More specifically, this leader will be expected to provide scientific and clinical support as the company investigates new e