Clinical Development Executive Medical Director

Role Responsibilities Lead, develop, and execute the clinical development plan for Enfortumab vedotin in alignment with the Lifecycle Management Plan and Integrated Product Plan. Own clinical development strategy, trial design, execution, and delivery of trial results. Integrate regulatory, statistical, and stakeholder input into study designs. Lead the product-specific Global Development Team; serve as clinical subject matter expert. Endorse clinical development decisions prior to GPT/senior management/governance reviews. Provide oversight/management for 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. Own safety decisions and clinical pharmacology for optimal dose/schedule selection. Lead clinical content preparation for regulatory submissions/documents (e.g., NDA/MAA/IND/sNDA, IB, AR/DSRU, label/Core Data Sheet/Package Insert). Provide clinical input for meetings with health authorities and regulatory query responses. Support business development initiatives as appropriate (e.g., due diligence protocol design/conduct/review). Basic Qualifications Medical degree or advanced degree with relevant clinical/industry experience (typically 4+ years). 7+ years industry experience. 5+ years experience leading diverse teams. Prior management responsibilities for medical directors or clinical scientists. Preferred Qualifications Board certified/eligible in oncology (or equivalent). Experience across multiple clinical phases and oncology drug classes. Experience leading NDA, BLA, or MAA. Other Ability to travel globally as needed; may work outside typical hours. Individual contributor or management responsibility for 1-6 Associate Medical Directors/Medical Directors/Senior Medical Directors. Reports to Therapeutic Area Head. #J-18808-Ljbffr Scorpion Therapeutics