Responsibilities:
- Lead cross-functional clinical development for assigned internal medicine/obesity asset(s), serving as single clinical point of accountability.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents.
- Negotiate tradeoffs/milestones to deliver the clinical program on time and within budget.
- Develop global clinical development plans (incl. pediatric investigation plan/study plan), and provide input to target product profiles.
- Partner with trial clinicians on governance reviews; provide therapy area/indication expertise (e.g., CRF design, signal interpretation, AE contextualization).
- Lead trial-level/statistical contributions (SAP, TLFs/table-listings-figures, database release) with statistics/programming.
- Develop submission deliverables (IAP/IARP, submission TLFs; SCE/SCS), review safety narrative plan, support label development/maintenance.
- Support regulatory submissions and product defense (e.g., DSUR, PBRER).
- Engage external stakeholders (e.g., advisory boards, steering committees, DMC/adjudication committees, patients/patient advocates) to drive strategy.
Qualifications:
- MD or DO.
- Endocrinologist/internal medicine physician with cardiometabolic late-stage experience, including type 2 diabetes.
- 8+ years clinical R&D experience; expertise in clinical development, global/regional regulation, ICH/GCP, adverse event management.
- Demonstrated clinical/administrative/project management; strong communication; experience managing/training large teams (designing/launching large teams preferred).
- Up to 30% travel; hybrid role (on-site ~2.5 days/week).
Benefits/Compensation (if hired): Base salary $274,500β$457,500; bonus target 25%; 401(k) with match; health/dental/vision and paid time off/caregiver leave.