Global Development Lead, Internal Medicine (MD, Sr. Director)

Responsibilities
- Lead clinical development for assigned Internal Medicine/Obesity assets as single clinical point of accountability.
- Create and gain endorsement for the Clinical Development Plan and protocol design documents; ensure study design, execution, and interpretation.
- Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) and partner with trial clinicians through governance reviews.
- Negotiate clinical program tradeoffs, milestones, timelines, and budget.
- Develop enabling clinical strategies (including digital/innovation and patient engagement).
- Provide therapy-area/indication expertise (CRF design, signal interpretation, adverse event contextualization).
- Contribute to statistical analysis plan, TLFs, database release; develop submission deliverables (IAP/IARP, submission TLFs, SCE, SCS).
- Support regulatory submissions and disclosures (DSUR, PBRER), product label development/maintenance, and submission safety narrative plan.
- Engage external stakeholders (e.g., advisory boards, Steering Committees, DMC, adjudication committees, patients).

Qualifications
- MD or DO.
- 8+ years clinical research/development experience (academia and/or biopharma).
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Cardiologist strongly preferred (cardiovascular outcome trials/large complex global programs).
- Demonstrated ability managing/training large clinical teams; experience designing/launching large teams preferred.

Skills/Competencies
- Medical/scientific excellence; strong matrix leadership and influencing.
- Conflict management, team building, accountability, and ability to work in change.

Requirements/Other
- Up to 30% travel; hybrid (live within commuting distance; ~2.5 days/week on-site).