Global Development Lead, Internal Medicine; Sr. Director

Role

Summary:

The Global Development Lead (GDL) is the single clinical point of accountability for clinical development for assigned asset(s). Leads cross-functional clinical development team design, execution, and interpretation of studies supporting worldwide regulatory submissions.

• Create and gain endorsement for the Clinical Development Plan and associated protocol design documents.
• Lead clinical program delivery in line with timelines and budget; negotiate tradeoffs with the Prod Team Lead.
• Own global clinical development plan for approval and reimbursement; develop pediatric investigation/study plan and protocol documents.
• Provide input for target product profile(s) and regulatory activities (product labels, core data sheets, Investigator Brochures, DSUR, PBRER, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports).
• Partner with trial clinicians on governance (Sci/Ops) and provide category strategy input.
• Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event context).
• Support trial-level statistical analysis plan and TLF/database release with statistics/programming.
• Develop submission-level deliverables (IAP, IARP, submission TLFs; SCE and SCS); review/approve submission safety narrative plan.
• Support product label development/maintenance and communication of clinical trial data.
• Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients) to inform clinical strategy and PDD development.
• Ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.

• BS with 12 years or PhD with 7 years relevant clinical/industry experience.

• Leading cardiometabolic late-stage development (including type 2 diabetes).
• Track record of success in academia and/or biopharma clinical R&D.
• Deep knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
• Demonstrated clinical/medical, administrative, and project management; strong written/verbal communication.
• Experience managing/training large clinical development teams; experience designing/launching large teams preferred.

• Medical/scientific credibility; leadership; matrix influence; conflict management; team building; accountability; agility in uncertainty; ability to influence/collaborate, coach others, and oversee colleagues’ work.

• Up to 30% travel; hybrid role with on-site ~2.5 days/week.