Associate Director, Regulatory Affairs

**++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 a subject matter expert on regulatory systems (e.g., Veeva Vault), overseeing system use in collaboration with IT and Quality, user training and data archiving. * Contribute to department infrastructure development by initiating processes targeted towards efficiency, quality, compliance and collaboration. **Regulatory Interactions** * Act as a primary contact for regulatory authorities (e.g., FDA, EMA) for early and/or late-phase development programs. * Plan and participate in meetings with regulatory agencies, preparing briefing packages, and coordinating follow-ups. * Monitor and interpret regulatory guidelines and communicate implications to internal stakeholders. **Cross-Functional Collaboration** * Work closely with research, development, CMC, and quality teams to ensure seamless regulatory support. * Provide regulatory input during protocol development, study design, and data interpretation. * Train and mentor team members on regulatory processes and requirements. **Qualifications** * Bachelor's degree in life sciences, pharmacy, or related field; advanced degree (PhD, PharmD, MS) preferred. * 7 years of experience in regulatory affairs with a strong emphasis on early-phase drug development. Oncology, rare disease, or similarly complex experience is required. * Demonstrated experience in preparing and submitting regulatory filings (e.g., INDs, CTAs). **Knowledge and Skills** * In-depth knowledge of regulatory requirements and guidelines (FDA, EMA, ICH, etc.). * Proven ability to manage multiple projects and priorities in a fast-paced environment. * Strong interpersonal and communication skills, with experience engaging regulatory agencies. * Experience with immunotherapies or biologics is highly desirable. Washington State Pay Range $178,219---$212,873 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++** Immunome, 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).