Responsibilities
- Act as medical expert and leader in interactions with external stakeholders.
- Develop unique and innovative clinical strategies to significantly shorten the development cycle in an evolving regulatory landscape; design efficient, robust Phase 2/3 programs.
- Partner with discovery teams to provide input on next-generation targets and lead Phase 1 clinical testing plans for initial characterization of PK/PD and safety.
- Ensure drug safety, including patient safety in clinical studies and signal detection from post-marketing surveillance (with Global Patient Safety support).
- Plan and execute publication and clinical communication strategy with the Publications team; provide input to key external presentations.
- Ensure quality of clinical documents (e.g., Investigatorsβ Brochure, protocol, study report, regulatory submission clinical components, safety documents); develop written responses to regulatory agency questions.
Qualifications
- Minimum advanced degree in medicine (M.D., D.O., or equivalent).
- Clinical training in Endocrinology or Cardiology (board certified or eligible/equivalent) strongly preferred.
- Minimum 4 years of relevant industry clinical development experience, including protocol design, study start-up management, directing/guiding study team execution, data cleaning, medical monitoring/review, and database locks.
- Experience with regulatory filings and interactions with health authorities preferred.
Work Location/On-site Requirement
- 4 days/week weekly on-site presence in Tarrytown, NY or Warren, NJ.