Vice President, Clinical Development – Oncology
Biotech, Remote
We are seeking a Vice President, Clinical Development to lead oncology programs for a growing biotech company. This role is ideal for a board-certified oncologist with extensive experience in clinical development, regulatory strategy, and drug development in oncology.
Key Responsibilities
- Lead the clinical development strategy for oncology programs, ensuring alignment with regulatory, scientific, and commercial objectives.
- Oversee the design, execution, and analysis of Phase I-III clinical trials, working closely with cross-functional teams.
- Serve as a key clinical expert in regulatory interactions (FDA, EMA, etc.), contributing to INDs, NDAs, and BLAs.
- Provide strategic leadership on biomarker-driven trials, immuno-oncology, targeted therapies, or novel oncology treatments.
- Collaborate with R&D, medical affairs, commercial teams, and external KOLs to drive clinical innovation.
- Develop and maintain relationships with investigators, regulatory agencies, and external partners.
- Represent the company at scientific conferences, advisory boards, and industry meetings.
Qualifications
- MD or MD/PhD, board-certified oncologist required.
- 10+ years of clinical development experience, with a strong background in oncology drug development in biotech or pharma.
- Proven track record in leading clinical trials (Phases I-III) and successfully navigating regulatory submissions.
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements for oncology drug development.
- Experience working in a biotech environment, with the ability to thrive in a fast-paced, innovative setting.
- Excellent leadership, communication, and strategic thinking skills.