Executive Director, Clinical Development

Role Summary

Executive Director, Clinical Development. The role provides strategic direction and oversight for the clinical development of Immunome’s oncology pipeline, from early development through late-stage trials, and represents the company with regulators and external stakeholders.

Responsibilities

• Provide strategic clinical leadership and responsibility for all clinical deliverables.
• Develop protocols aligned with Clinical Development Plans (CDP), regulatory documents, and medical communications.
• Manage operational aspects and drive execution of the clinical program in partnership with other functions.
• Manage budget and resources with the CMO and Project Managers to ensure timely deliverables.
• Engage with external stakeholders (regulatory authorities, key opinion leaders, advisory boards, patient groups) and internal decision boards.
• Develop and maintain relationships with internal and external scientific experts to represent the company clinically.
• Support the CMO in ensuring overall safety of the compound in collaboration with the Safety Leader.
• Stay current with clinical and drug development information through literature review and scientific meetings.
• Lead development and implementation across program-specific standards.

Qualifications

• M.D. with clinical research experience in oncology required.
• Minimum 10+ years of clinical development experience in oncology.
• Proven track record of advancing oncology programs through pivotal/registrational trials; prior leadership in large pharma or biotech strongly preferred.

Knowledge And Skills

• Deep expertise in oncology clinical trial design and execution across early and late-stage studies.
• Thorough knowledge of FDA, EMA, and ICH regulations for oncology drug development; proven ability to lead regulatory interactions globally.
• Ability to design, run, and analyze global clinical studies.
• Strong understanding of translational medicine, clinical pharmacology, and integration of biomarker insights into development strategy.

Education

• Not specified in the description.