Executive Director, Clinical Development

Warman O'Brien; United States; On-site; USD 200,000 - 250,000; Full time

Job summary

Warman O'Brien is seeking a Vice President / Executive Director for Clinical Development in the United States. This role demands a senior leader to advance a late-stage oncology program, integrating both strategic and operational contributions.

The ideal candidate holds an MD or MD/PhD with a proven track record in oncology clinical development, regulatory submissions, and collaboration with various stakeholders. This position requires hands-on leadership in a fast-paced biotech environment.

Qualifications

• Significant oncology clinical development experience within biotech and/or pharma.
• Proven track record leading oncology programs with late-stage development experience.
• ADC and/or immuno-oncology expertise highly preferred.
• Experience working globally with regulatory agencies including the FDA.

Responsibilities

• Lead clinical development activities across a global oncology program.
• Provide scientific and medical leadership throughout the clinical development lifecycle.
• Collaborate cross-functionally with Clinical Operations, Biometrics, and external partners.
• Contribute to interactions with regulatory authorities and scientific stakeholders.

Skills

Oncology clinical development experience

Scientific and medical leadership

Cross-functional collaboration

Regulatory interactions with FDA

Comfortable in fast-paced biotech

Experience in publication planning

Education

MD or MD/PhD

Job description

Vice President / Executive Director, Clinical Development

Oncology

An innovative clinical-stage biotech is seeking a senior Clinical Development leader to help advance a late-stage oncology program through a pivotal stage of growth. This is a highly visible, hands‑on leadership role reporting directly into executive leadership, with broad influence across clinical strategy, study design, execution, and regulatory interactions.

The company is progressing a promising solid tumour asset, supported by a strong financial runway and a collaborative, low‑ego culture where individuals are encouraged to contribute both strategically and operationally.

Key Responsibilities

• Lead clinical development activities across a global oncology program
• Provide scientific and medical leadership throughout the clinical development lifecycle, from protocol design through data analysis and regulatory submissions
• Collaborate cross‑functionally with Clinical Operations, Biometrics, Translational Sciences, and external CRO/vendor partners
• Contribute to interactions with global regulatory authorities and external scientific stakeholders
• Support publication planning, scientific communications, and broader development strategy

Ideal Background

• MD or MD/PhD with significant oncology clinical development experience within biotech and/or pharma
• Proven track record leading oncology programs, ideally with later‑stage development experience
• ADC and/or strong immuno‑oncology expertise highly preferred
• Comfortable working in a lean, fast‑paced biotech environment with a hands‑on approach
• Experience working globally and engaging with regulatory agencies including the FDA