Global Development Lead, Internal Medicine; Sr. Director

Role Summary / Responsibilities:

• Lead cross-functional Clinical Development Team for assigned asset(s); oversee design, execution, and interpretation of studies supporting worldwide regulatory submissions.
• Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; ensure trial feasibility and optimized operational execution.
• Partner with the Prod Team Lead to negotiate tradeoffs, milestones, and deliver the clinical program within timelines and budget.
• Provide therapy area/indication expertise for clinical data review (e.g., CRF design, signal interpretation, adverse event contextualization).
• Contribute to statistical analysis and trial deliverables (TFLs, table-listings-figures, database releases).
• Lead submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission safety narrative plan.
• Support product label development/maintenance.
• Provide regulatory submission support (DSUR, PBRER) and product defense.
• Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients/advocates) to inform clinical development strategy.

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

• Lead cardiometabolic late-stage development programs (including type 2 diabetes).
• Track record in academia and/or biopharmaceutical industry clinical R&D; extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
• Demonstrated project/admin management, strong verbal/written communication, and ability to manage/train large clinical development teams.

• Matrix leadership and influencing; conflict management; accountability; ability to operate in uncertainty.

• Experience designing/launching large teams.