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Associate Director, Regulatory Affairs

Immunome Inc - Bothell, Washington, United States

Posted May 21, 2026

Benefits

Parental leave
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Non-birth-parent leave
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Family-building benefits
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  • Adoption assistance: Not verified
  • Surrogacy assistance: Not verified
Mental health support
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Relocation assistance
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Childcare support
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Learning budget
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Verification
Not verified checked Jun 13, 2026
Salary
$178K-$213K not verified - source not recorded; timestamp not recorded
401(k) match
Reported from DOL Form 5500 industry filing (not employer-specific)

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Schedule

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Weekend work
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Application

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Where they hire

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About this role

Associate Director, Regulatory Affairs Bothell, Washington, United States Company Overview 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 Overview This key role will focus on the tactical and strategic oversight of early-phase and late-phase regulatory activities to ensure compliance and support innovative product development. The successful candidate will combine hands-on expertise in regulatory affairs with a proactive approach to solving complex challenges in clinical development. Responsibilities Regulatory Strategy Development - Contribute to the design and execution of global regulatory strategies for early-phase development programs. - Provide regulatory guidance to cross-functional teams, ensuring alignment with Immunome's objectives and compliance with regulatory requirements. - Identify and assess potential regulatory risks and develop mitigation strategies. Tactical Implementation - Prepare, review, and submit regulatory documents for early and late-phase clinical programs (e.g., INDs, CTAs, amendments). - Coordinate and oversee the preparation of technical content, including CMC, non-clinical, and clinical sections of regulatory submissions. - Manage timelines and ensure regulatory milestones are met. - Serve as

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