Global Development Lead, Internal Medicine (Sr. Director)

Responsibilities:

• Lead cross-functional Clinical Development Team for assigned Internal Medicine/R&D assets; design, execute, and interpret studies supporting worldwide regulatory submissions.
• Create and gain endorsement for Clinical Development Plan and associated protocol design documents; ensure delivery aligned to timelines/budget.
• Accountable for clinical development plan for global approval/reimbursement (incl. China/Japan) and pediatric investigation plan/study plan.
• Provide product/program input for target product profiles; drive innovative/bold clinical development decisions.
• Develop enabling strategies (digital/innovation and patient engagement).
• Partner with trial clinicians on governance reviews and provide category/therapy-area expertise (CRF design, signal interpretation, adverse event contextualization).
• Support trial-level statistical analysis plan, TLFs/table-listings-figures, and database release (with statistics/programming).
• Develop submission deliverables (IAP/IARP/submission TLFs) including SCE/SCS; review/approve submission safety narrative plan; support label development/maintenance.
• Support regulatory submission deliverables (DSUR, PBRER) including product defense; ensure compliance with SOPs and regulatory standards.

Qualifications/Requirements:

• BS with 12 years or PhD with 7 years relevant clinical/industry experience.
• Experience leading cardiometabolic late-stage development (incl. type 2 diabetes); success in academic and/or biopharma clinical R&D.
• Deep knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.

Preferred/Additional Skills:

• Proven ability to manage/train large teams; demonstrated leadership in designing/launching large teams.
• Strong verbal/written communication; influence in complex matrix environments; accountability and conflict management.

Benefits (explicitly stated):

• Relocation support
• bonus target 22.5% and access to long-term incentive
• comprehensive health, paid leave, and 401(k) with company match (plus additional retirement contribution)