Executive Director, Medical Director- Diabetes

Position Summary:
The Medical Director, Diabetes is the medical leader contributing to the development and lifecycle management strategy across diabetes mellitus (Type 1, Type 2, Gestational Diabetes) and company products addressing this condition. Leads medical strategy for scientific exchange to ensure scientific accuracy and strong clinical evidence.

Key Responsibilities:
- Advance diabetes clinical programs, integrating parenteral and pulmonary drug delivery strategies where relevant.
- Synthesize scientific, clinical, regulatory, and competitive insights to guide pipeline prioritization and evidence strategies; inform long-range portfolio/lifecycle planning.
- Partner with the TA Head on diabetes lifecycle management strategy aligned with scientific platforms and inhaled-therapeutic technologies.
- Spearhead design/planning of Phase 1–4 trials (dose selection, patient segmentation, biomarker strategy, endpoint development).
- Engage endocrinology (and pediatrics) experts to refine rationale, strengthen mechanistic understanding, and optimize development pathways.
- Oversee advisory board strategy and ensure study designs reflect real-world practice and unmet need.
- Guide execution and oversight of diabetes clinical programs; ensure data integrity and statistical rigor; support risk-benefit assessment and safety surveillance.
- Provide input into CRO/vendor oversight and global study execution; ensure GCP/ethical/regulatory compliance and inspection readiness (FDA, EMA, global).
- Lead medical monitoring (as medical monitor or via delegated oversight).
- Drive regulatory strategy and submissions (INDs, NDAs/BLAs, briefing docs, CSRs, agency responses) and represent the TA in regulatory interactions.
- Contribute to key scientific/regulatory documents (protocols, CSRs, investigator brochures, scientific communications).
- Provide Medical Affairs content leadership; support non-promotional scientific messaging and publication planning.
- Analyze/interpret clinical data and integrate strategic insights to refine development strategy and advise leadership.
- Partner with Commercial/Market Access/Business Development; support diligence for in-licensing/collaborations; contribute to enterprise governance.
- Mentor medical colleagues and foster a culture of scientific excellence and cross-functional collaboration.

Qualifications:
- M.D. required; clinical practice experience preferred (ideally diabetologist/endocrinologist). Additional PhD/MPH/MBA valued.
- 10+ years progressive medical affairs and/or clinical development experience in pharma/biotech.
- Demonstrated diabetes expertise; pediatric endocrinology and/or maternal-fetal medicine preferred.
- Ability to lead/influence cross-functional teams; collaborate with investigators; represent programs globally.
- Exceptional scientific communication/analytical/leadership skills.
- Ability/willingness to travel ~20% (primarily domestic).
- Deep understanding of clinical development methodologies and lifecycle management; knowledge of U.S. and ex-U.S. regulatory/clinical research requirements for diabetes drug development.

Pay Range: $224,000 - $336,000 per year.