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, or equivalent experience. Oncology , rare disease, or similar ly 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) .