Executive Director; Medical Strategy- Boston
Duties and Responsibilities:
- Serve as U.S. Medical Director for multiple global clinical development trials and/or U.S. Medical Affairs Trials (including phase I-IV, Expanded Access, Investigator Initiated, registries and Compassionate Use). Interface with Global and U.S. Clinical Team Members, Clinical Operations, Scientific Operations, Regulatory Affairs, Drug Supply, Data Management, Finance, Quality, Compliance, and other relevant functional areas as well as Partners.
- Design and optimize clinical trial design and ensure clinical trials meet ethical and regulatory standards including:
- Write and review protocols that are in-line with the overall indication strategy.
- Conduct medical review and interpretation of efficacy and safety data from clinical trials.
- Responsible for the quality, coordination, medical accuracy, and timeliness of clinical study reports, clinical sections of INDs, Investigator Brochures, CTAs, ISS’s, ISE’s, clinical expert reports, and label reviews.
- Review and provide US feedback to Global Protocols and Global Development Plans.
- Develop strategy for US Medical Affairs including exploratory indications and integrate US plan with overall Global Medical Affairs strategy. Oversee the review and approval of IIT concepts. Oversight during the conduct of trials including safety monitoring. Review of interim and final publication, manuscripts, or abstracts.
- Provide strategic input to individual clinical trial strategy and participate in strategy setting for clinical trial program.
- Supervise and manage individuals on the US CDMA team as appropriate. Lead the Clinical Team, including interactions with Safety, HEOR, Marketing, Regulatory, Research, and other functions.
- Work with Clinical Team and other functions to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (i.e. IB, IND sections), for Company Sponsored project.
- Review and approve abstracts publications & manuscripts for Investigator Initiated Trials to ensure clinical accuracy and appropriate safety review.
- Present and discuss data and findings at relevant internal and external meetings.
- Lead US cross functional Medical Product Teams and activities; Medical representative to the Brand team.
- Support and participate in FDA meetings including presentations, briefing books, and responding to FDA inquiries as needed.
- Extensive interactions with academic thought leaders to optimize clinical trial strategies.
- Extensive interactions with other functional teams including HEOR, Medical Information, Scientific Communication, Commercial, Regulatory and others, to define compound strategy and projects.
- Coach and train internal colleagues as requested.
- Assist in the development and appropriate spending of clinical budget.
- Ensure adherence to GCP/ICH and company Standard Operating Procedures (SOPs).
Experience and Qualifications:
- MD, board certified or board eligible in either internal Medicine, Endocrinology, Cardiology or relevant Medical Specialty preferred.
- At least 5 years of experience in Diabetes clinical research in the pharmaceutical industry OR experience in clinical research or medical affairs is preferable or a combination of experience in academic medicine with clinical research and or clinical development experience in collaboration with the pharmaceutical industry.
- Scientific medical research experience in Cardiology, Diabetes or Metabolism with demonstrated record of scientific medical publications. Experience within diabetes therapeutic area highly preferred.
- Experience leading the design, conduct, analysis and reporting of clinical studies is strongly preferred.
- Superior leadership, networking, collaboration and communication skills.
- Successful interactions with Medical Experts and investigators.
- Demonstrated the capability for strategic planning along with operations skill and experience related to clinical research involving both single and multiple centers.
- Ability to work across multiple functions is essential.
- Effective oral and written communications skills and strong leadership are essential for success in the role.
Please email CV to firstname.lastname@example.org