Executive Director, Clinical Development

Role Summary

The Executive Director, Clinical Development will serve as a key member of Immunome’s R&D leadership team, reporting to the Chief Medical Officer. This executive will provide strategic direction and oversight for the clinical development of Immunome’s pipeline, advancing innovative targeted oncology programs from early development through late-stage trials. The role will shape portfolio strategy, lead global clinical trial execution, and represent Immunome with regulators, investigators, and external stakeholders.

Responsibilities

• Provide strategic clinical leadership and hold responsibility for all clinical deliverables.
• Development of protocols consistent with the Clinical Development Plans (CDP), clinical components of regulatory documents and brand related medical information, clinical communication, and publications.
• Manage operational aspects and drive execution of the clinical program in partnership with other line functions.
• Manage budget and resources in coordination with CMO, and Project Managers, ensuring timely execution of assigned clinical deliverables.
• Participate in/contribute to activities with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal stakeholders, Translational Medicine, etc.) and internal decision boards.
• Develop and maintain strong relationships with both internal and external scientific experts in order to represent the company’s interests from a clinical perspective.
• Support the CMO in ensuring overall safety of the compound in collaboration with the Safety Leader for the assigned program section.
• Remain current with clinical and drug development information relevant to assigned programs through the review of literature and attendance at medical/scientific meetings.
• Lead development and ensure implementation across program specific standards.

Qualifications

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

Knowledge & Skills

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