Clinical Development Executive – Medical Director

• Define and execute the development strategy of Enfortumab vedotin within the GU Therapeutic Area
• Lead, develop and execute the clinical development plan in alignment with lifecycle management and integrated product plans
• 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 subject matter expert on clinical issues
• Endorse clinical development decisions for governance and senior management reviews
• Oversee and manage medical directors or clinical scientists
• 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
• Make clinical evaluations and safety decisions with safety colleagues
• Define optimal dose and schedule selection with clinical pharmacology
• Lead clinical content preparation for regulatory submissions and documents
• Provide clinical input for health-authority meetings, regulator discussions, and regulatory query responses
• Support business development and due diligence initiatives through protocol design, conduct, or review
• Influence and collaborate with peers, develop and coach others, and guide colleagues toward meaningful outcomes

• Medical degree or advanced degree with relevant clinical/industry experience, typically 4+ years
• 7+ years of industry experience
• 5+ years of experience leading diverse teams
• Prior management responsibilities for medical directors or clinical scientists
• Board certified/eligible in oncology or equivalent preferred
• Experience across multiple phases of clinical development and drug classes in oncology preferred
• Experience leading NDA, BLA, or MAA preferred
• Ability to travel globally as needed
• Ability to work outside typical hours to accommodate other time zones and time-sensitive business needs
• Candidates must be authorized to be employed in the U.S. by any employer
• Permanent work authorization in the United States required

Demonstrates expertise in clinical development strategy, trial design, and execution within the oncology domain, while effectively leading diverse teams and managing clinical protocols and regulatory submissions.

• Clinical Development Strategy
• Oncology Expertise
• Regulatory Submissions
• Team Leadership
• Clinical Trial Design

• Clinical Development
• Trial Design
• Data Interpretation
• Dose Selection
• Safety Decision Making
• Clinical Protocols
• Study Reporting
• Regulatory Query Responses
• NDA Experience
• BLA Experience

• Collaboration
• Coaching
• Influencing
• Communication
• Leadership

• Medical Degree
• Board Certified in Oncology

• GU Therapeutic Area
• Clinical Development Plan
• Global Development Team
• Health-Authority Meetings
• Clinical Pharmacology
• Drug Classes
• Clinical Scientists
• Medical Directors
• Lifecycle Management
• Business Development