Senior Director, Clinical Development

Senior Director, Clinical Development

Bothell, Washington, United States

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

Position summary:

We are seeking an accomplished Senior Director, Clinical Development to join our passionate and collaborative team and drive the advancement of our pipeline of targeted cancer therapies. In this high-impact role, you will lead clinical strategy and execution within our innovative portfolio of ADC and radioligand therapies across all stages of development.

Key Responsibilities:

• Lead and execute the clinical development strategy for novel oncology therapies.
• Collaborate with internal and external stakeholders to design and implement a clinical development plan across indications.
• Author/lead key clinical trial documents and clinical sections of regulatory filings such as pre-INDs and INDs.
• Serve as the primary Medical Monitor for assigned programs, including overseeing internal and external teams and providing medical guidance to CRO partners and clinical sites.
• Support safety monitoring and pharmacovigilance activities.
• Collaborate cross-functionally with clinical operations, regulatory, project management, manufacturing, and business development to define timelines, manage risks, and ensure milestone delivery.
• Work closely with translational sciences to integrate key biomarker and pharmacodynamic endpoints into clinical study designs
• Establish and maintain strong relationships with PIs, KOLs and other external stakeholders.
• Review, assess, interpret, and communicate clinical trial data to internal stakeholders and external partners.
• Lead clinical trial data publication efforts.
• Facilitate key meetings such as advisory boards, safety review committees, investigator meetings.

Qualifications:

• M.D., D.O. or equivalent. Board certification in medical oncology or hematology preferred.
• A minimum of 2-4+ years of experience leading Clinical Development and Phase 1 – 3 oncology clinical trials in a biotech or pharmaceutical setting.

Knowledge and Skills:

• Proven experience advancing therapeutic programs from IND-enabling studies through early and late-stage clinical development
• Understanding of FDA and EMA regulatory requirements and successful track record in regulatory interactions
• Demonstrated leadership and ability to effectively manage cross-functional teams

Washington State Pay Range

$342,561 - $389,125 USD

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

E-Verify

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