Executive Director, Clinical Development

Role Summary

Executive Director, Clinical Development will serve as a key member of Immunome’s R&D leadership team, providing strategic direction and oversight for the clinical development of Immunome’s pipeline from early development through late-stage trials. The role involves shaping portfolio strategy, leading global clinical trial execution, and representing Immunome with regulators, investigators, and external stakeholders.

Responsibilities

• Provide strategic clinical leadership and hold responsibility for all clinical deliverables.
• Develop 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 to represent the company‚Äôs 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 And 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.

Educational Background