Global Development Lead, Internal Medicine; MD, Sr. Director

Role Summary

The Global Development Lead (GDL) represents Clinical on the Global Medicine Team and is the single clinical point of accountability for clinical development for assigned asset(s). Leads cross-functional clinical development activities (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) to design, execute, and interpret studies supporting worldwide regulatory submissions. Accountable for creating and gaining endorsement for the Clinical Development Plan and associated protocol design documents.

• Partner with Medicine Team Lead to negotiate tradeoffs, milestones, and deliver the clinical program on agreed timelines and budget.
• Develop comprehensive clinical development plans for global approval and reimbursement (including China and Japan), including pediatric investigation/study plan and protocol design documents.
• Provide product/program input for target product profile(s); bring innovative thinking and bold decision-making.
• Develop clinical development enabling strategies (digital/innovation and patient engagement).
• Partner with trial clinicians on governance reviews (incl. Sci/Ops) and provide category strategy input.
• Provide therapy area/indication expertise for clinical review (CRF design, signal interpretation, adverse event contextualization).
• Provide specialized medical monitoring support if required.
• Partner on trial-level statistical analysis plan, TLFs, listings/figures, and database release.
• Develop submission-level deliverables (IAP, IARP, submission TLFs), including SCE and SCS; support interpretation/communication of data.
• Review/approve submission-level safety narrative plan; support product label development and maintenance.
• Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/patient advocates) to support development strategy and PDD.
• Provide regulatory submission support (DSUR, PBRER), disclosure deliverables, and product defense; ensure compliance with SOPs and external regulatory standards.
• Review IIR proposals.

• MD or DO.
• 8+ years relevant clinical research and development experience (academia and/or biopharmaceutical industry).
• Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex global development programs.
• Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.

• Demonstrated clinical/medical, administrative, and project management; strong written/verbal communication.
• Demonstrated experience managing/training large clinical development teams; experience designing/launching large teams preferred.
• Leadership, influencing, conflict management, team building, accountability, and ability to operate in matrixed environments.

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

Education/Experience included above.