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 Internal Medicine asset(s).
• Leads the cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) to design, execute, and interpret studies supporting worldwide regulatory submissions.
• Accountable for creating and securing endorsement of the Clinical Development Plan and associated protocol design documents.
• May assume additional clinical leadership for Obesity portfolio late-stage assets (trial design, execution, reporting).

Responsibilities

• Partner with the Prod Team Lead to negotiate tradeoffs, milestones, and ensure clinical program delivery within timelines and budget.
• Develop comprehensive clinical development plan to secure global approval and reimbursement (including China and Japan), including pediatric investigation/study plan and protocol design.
• Provide input for target product profiles; deliver clinical development enabling strategies (digital/innovation and patient engagement).
• Partner with trial clinicians on governance reviews; provide therapy area/indication expertise (CRF design, signal interpretation, adverse event contextualization).
• Support statistical analysis plan, TLFs/table-listings-figures, and database release.
• Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve safety narrative plan.
• Support product label development/maintenance; engage external stakeholders (Ad boards, steering committees, DMC, adjudication committees, patients).
• Provide regulatory submission support (DSUR, PBRER), product defense, and ensure compliance with SOPs and regulatory standards.

Basic Qualifications

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

Experience/Required Skills

• Experience leading cardiometabolic late-stage development (including type 2 diabetes).
• Track record of success in academia and/or biopharma clinical R&D.
• Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
• Demonstrated clinical/medical, administrative, and project management skills; strong verbal and written communication.
• Demonstrated ability to manage and train large clinical development teams (and design/launch large teams preferred).

Competencies

• Scientific credibility/excellence; leadership and influencing in matrix environments; conflict management and team building; accountability; ability to operate amid uncertainty and organizational change.

Non-standard Work/Environment

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

Relocation

• Relocation support available.