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Immunome, Inc. · 5 hours ago

Executive Director, Clinical Development

Bothell, WA

Full-time

Onsite

Director/Executive

$385K/yr - $425K/yr

10+ years exp

Immunome, Inc. is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. The Executive Director, Clinical Development 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.

BiopharmaBiotechnologyMedicalPharmaceutical

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

Qualification

M.D.Clinical research experienceOncology clinical trial designFDA regulations knowledgeClinical development experienceRegulatory interactions leadershipTranslational medicine understandingClinical pharmacology knowledgeBiomarker integration strategyLeadership experience

Required

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

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

Preferred

Prior leadership experience in large pharma or biotech strongly preferred

Company

Immunome, Inc.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients.

Founded in 2008

Exton, Pennsylvania, USA

51-200 employees