Global Development Lead, Internal Medicine (Sr. Director)

Responsibilities

• Lead cross-functional Clinical Development Team for assigned internal medicine asset(s); accountable clinical point for design, execution, interpretation of studies supporting worldwide regulatory submissions.
• Create and gain endorsement for Clinical Development Plan and protocol design documents; partner across study lifecycle.
• Lead/oversee pediatric investigation plan/study plan and protocol design for pediatric feasibility and optimized execution.
• Provide input to target product profiles and regulatory deliverables (e.g., product labels, core data sheets, Investigator Brochures, DSUR, PBRER, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports).
• Partner with trial clinicians on governance reviews; provide category strategy and therapy area/indication expertise (CRF design, signal interpretation, AE contextualization).
• Support trial statistical analysis plan (tables/listings/figures, database release) and submission-level deliverables (IAP, IARP, submission TLFs; SCE, SCS, safety narrative plan).
• Support medical monitoring (if required), external stakeholder engagement (Ad boards, Steering Committees, DMC, adjudication committees, patients/advocates), product label development/maintenance, and regulatory disclosure and product defense.

Basic Qualifications / Requirements

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

Experience

• Lead cardiometabolic late-stage development (including type 2 diabetes); track record in academia/biopharma clinical R&D.
• Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
• Demonstrated clinical/medical, administrative, and project management; effective communication.
• Manage and train large clinical development teams; designing/launching large teams preferred.

Competencies (high level)

• Medical/scientific excellence; matrix leadership and influence; leadership and conflict management; team building; accountability; adaptability.

Other

• Up to 30% travel may be required.