Associate Director / Director, Regulatory Affairs CMC
Immunome, Inc.About the role
<div class="content-intro"><p><strong><u>Company Overview</u></strong></p> <div class="x_elementToProof" data-olk-copy-source="MessageBody"> <div data-olk-copy-source="MessageBody">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 accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.</div> </div></div><p><span style="text-decoration: underline;"><strong><span data-contrast="auto">Position Overview</span></strong></span></p> <p><span data-contrast="auto">Immunome is seeking an Associate Director / Director, Regulatory Affairs CMC, responsible for developing and executing global regulatory CMC strategies across multiple modalities. This individual will manage key deliverables and ensure adherence to accelerated regulatory submission schedules. Reporting into the Senior Director, Regulatory Affairs CMC, the role is responsible for communications and interactions with global regulatory authorities. This person will collaborate cross-functionally with teams including Technical Operations, Quality Assurance, Supply Chain Management, and Project Management to maintain alignment with regulatory CMC strategies and compliance requirements. </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":259}"> </span></p> <p><span style="text-decoration: underline;"><strong><span data-contrast="auto">Responsibilities</span></strong></span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="25" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","4697
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