Clinical Development Executive Medical Director

ROLE SUMMARY

This position is for a Clinical Development Executive Medical Director within the GU Therapeutic Area, responsible for defining and executing the development strategy of Enfortumab vedotin.

• Lead, develop, and execute the clinical development plan for Enfortumab vedotin across the Global Development Team, aligned to lifecycle and integrated product plans.
• Own clinical development strategy, trial design, execution, and trial results delivery.
• Integrate regulatory, statistical, and stakeholder input into study designs.
• Lead product-specific Global Development Team; serve as clinical subject matter expert.
• Provide clinical governance support (endorse decisions ahead of reviews/governance).
• Oversee medical director(s); serve as primary interface with the Development Review Committee.
• Oversee clinical protocols/amendments, investigator brochures, and clinical study reports.
• Oversee evaluation, interpretation, reporting, presentation, and publication of study data.
• Accountable for safety decisions and clinical pharmacology input (optimal dose/schedule).
• Lead preparation of clinical content for regulatory submissions (e.g., NDA/MAA/IND/sNDA, IB, AR/DSRU, label changes, Core Data Sheet, Package Insert).
• Provide clinical input for health authority meetings; lead regulator discussions and regulatory query responses.
• Support business development/due diligence via protocol design/conduct/review as appropriate.

• Medical degree or advanced degree with relevant clinical/industry experience (typically 4+ years).
• 7+ years industry experience.
• 5+ years leading diverse teams.
• Prior management responsibilities for medical directors or clinical scientists.

• Board certified/eligible in oncology (or equivalent).
• Experience across multiple clinical phases and oncology drug classes.
• Experience leading NDA/BLA/MAA.

• Ability to travel globally as needed; may require work outside typical hours.
• Hybrid work location.