Executive Director, Clinical Development (Oncology)
A Biotech partner of ours is seeking an accomplished Executive Director of Clinical Development to provide strategic and operational leadership across oncology clinical programs. This role will be responsible for shaping and executing clinical development strategies across one or more solid tumor indications.
Key Responsibilities
- Lead clinical development strategy and execution across oncology programs, ensuring alignment with scientific, regulatory, and business objectives
- Provide oversight of clinical trial design, conduct, and data interpretation
- Serve as a senior clinical leader and key contributor to cross-functional governance and decision-making
- Lead, mentor, and develop a high-performing clinical development team
- Drive interactions with global health authorities (e.g., FDA, EMA) and external investigators
- Partner closely with research, regulatory, commercial, and other functions to advance programs efficiently
- Ensure timelines, budgets, and development milestones are met while maintaining high quality and compliance standards
Qualifications
- MD required with 10+ years of experience in pharmaceutical, biotechnology, or academic clinical development.
- Board-certified Oncologist preferred
- Proven track record leading oncology clinical development programs across multiple phases
- Deep knowledge of GCP, ICH, and global regulatory requirements; experience leading health authority interactions
- Demonstrated ability to analyze and interpret clinical data to drive strategic decisions
- Strong leadership, communication, and stakeholder management skills
- Experience contributing to or authoring clinical development strategies and governance materials
- Publication experience in peer-reviewed journals required
Preferred Experience
- Experience supporting registration-enabling strategies and regulatory submissions
- Prior involvement in NDA/BLA/MAA filings
- Ability to represent clinical development perspectives in senior-level internal and external forums
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