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

Responsibilities
- Lead cross-functional clinical development teams (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) to design, execute, and interpret studies for global regulatory submissions.
- Create and gain endorsement for Clinical Development Plan and protocol design documents; provide lifecycle partnership to clinical/clinical operations and external partners under the Partner of Choice model.
- Own global clinical development planning for approval and reimbursement; develop pediatric investigation/study plan and associated protocol documents.
- Provide therapy area/indication expertise for clinical review (CRF design, signal interpretation, adverse event contextualization).
- Lead/partner on trial governance; support trial-level statistical analysis plan, TLFs, and database release.
- Develop submission deliverables (IAP/IARP, submission TLFs), including SCE/SCS; review/approve submission safety narrative plan.
- Support product label development/maintenance.
- Provide regulatory submission support (DSUR, PBRER), disclosure deliverables, and product defense.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/patient advocates) to generate insights for clinical strategy and PDD development.
- Ensure compliance with SOPs and external regulatory standards; review IIR proposals.

Basic Qualifications
- MD or DO.
- Endocrinologist or internal medicine physician with cardiometabolic late-stage experience including type 2 diabetes.
- 8+ years of relevant clinical research and development experience; track record in academia and/or biopharma.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.

Preferred/Additional
- Demonstrated experience managing/training and designing/launching large teams in clinical development.
- Strong clinical/medical, administrative, and project management; verbal/written communication; matrix leadership and conflict management.

Travel/Location/Benefits/Instructions (if included)
- Up to 30% travel; hybrid role (live within commuting distance; average 2.5 days/week on-site).
- Relocation support available.
- Benefits include 401(k) with match, retirement contribution, vacation/holidays, caregiver/parental and medical leave, and medical/dental/vision.
- Eligible for Global Performance Plan bonus (25% target) and share-based long-term incentives.
- U.S. work authorization required; visa sponsorship not available.
- No application instructions provided in text.