Head of Asset in GU, Oncology Clinical Development

Job Responsibilities:
- Manages Medical and/or Scientific Directors and leads direction, planning, execution, and interpretation of clinical trials/research for one or more clinical development programs; participates in cross-functional teams to generate, deliver, and disseminate high-quality clinical data.
- Leads design and implementation of multiple clinical development programs (or one large complex program) supporting the product development plan; oversees project-related education of investigators and study site personnel.
- Leads and mentors clinical study teams; monitors study integrity; reviews, interprets, and communicates accumulating safety and efficacy data; works with Clinical Operations to ensure enrollment and timelines for key deliverables; assesses and reports serious adverse events per policy and regulations.
- Owns design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study reports, regulatory submissions/responses, and other program documents.
- Manages Medical/Scientific Directors and/or Clinical Scientists (hiring, onboarding, mentoring, training, career development).
- May chair Clinical Strategy Team(s) to develop a cross-functionally aligned Clinical Development Plan; may supervise matrix team members and serve as Clinical Research representative to Asset Development Teams.
- Serves as in-house clinical expert for molecules/diseases; coordinates scientific activities with internal stakeholders; may contribute to due diligence/business development; contributes translational strategy with Discovery.
- Acts as clinical lead for opinion leader interactions; partners with Medical Affairs, Commercial, and other functions to incorporate perspectives into plans and protocols.
- Stays current via conferences/literature/training; may represent the company at external meetings.
- Ensures compliance with regulatory requirements for clinical studies and global drug development; serves as clinical representative in key regulatory discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and quality standards.

Qualifications:
- M.D., D.O., or non-US equivalent M.D. with relevant therapeutic specialty (academic/hospital environment required); residency strongly preferred; subspecialty fellowship desirable.
- 7+ years (9+ preferred) clinical trial experience (pharma, academia, or equivalent).
- Ability to run a complex clinical research program independently.
- Proven leadership; ability to lead/manage through influence on global cross-functional teams.
- Demonstrated commitment to training/development of junior staff.
- Ability to interact externally and internally to support global scientific and business strategy.
- Extensive knowledge of clinical trial methodology, regulatory/compliance requirements, and clinical strategy/protocol design.
- Excellent oral and written English communication.
- Ability to exercise judgment and solve complex problems across multiple projects.