Senior Director, Clinical Development
$342.56k - $389.13kImmunome
divh2Senior Director, Clinical Development/h2pBothell, Washington, United States/ppImmunome 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./ppPosition summary:/ppWe 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./ppKey Responsibilities:/pulliLead and execute the clinical development strategy for novel oncology therapies./liliCollaborate with internal and external stakeholders to design and implement a clinical development plan across indications./liliAuthor/lead key clinical trial documents and clinical sections of regulatory filings such as pre-INDs and INDs./liliServe as the primary Medical Monitor for assigned programs, including overseeing internal and external teams and providing medical guidance to CRO partners and clinical sites./liliSupport safety monitoring and pharmacovigilance activities./liliCollaborate cross-functionally with clinical operations, regulatory, project management, manufacturing, and business development to define timelines, manage risks, and ensure milestone delivery./liliWork closely with translational sciences to integrate key biomarker and pharmacodynamic endpoints into clinical study designs/liliEstablish and maintain strong relationships with PIs, KOLs and other external stakeholders./liliReview, assess, interpret, and communicate clinical trial data to internal stakeholders and external partners./liliLead clinical trial data publication efforts./liliFacilitate key meetings such as advisory boards, safety review committees, investigator meetings./li/ulpQualifications:/pulliM.D., D.O. or equivalent. Board certification in medical oncology or hematology preferred./liliA minimum of 2-4+ years of experience leading Clinical Development and Phase 1 3 oncology clinical trials in a biotech or pharmaceutical setting./li/ulpKnowledge and Skills:/pulliProven experience advancing therapeutic programs from IND-enabling studies through early and late-stage clinical development/liliUnderstanding of FDA and EMA regulatory requirements and successful track record in regulatory interactions/liliDemonstrated leadership and ability to effectively manage cross-functional teams/li/ulpWashington State Pay Range/pp$342,561 - $389,125 USD/ppE/E/O/ppImmunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees./ppE-Verify/ppImmunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish) ./p/div
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