Associate Director, Regulatory Affairs

Bothell1d ago

Seniority: Lead

About the role

<div class="content-intro">Company Overview <div class="x_elementToProof" 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 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.</div></div>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   <ul> <li>Contribute to the design and execution of global regulatory strategies for early-phase development programs.  </li> <li>Provide regulatory guidance to cross-functional teams, ensuring alignment with Immunome’s objectives and compliance with regulatory requirements.  </li> <li>Identify and assess potential regulatory risks and develop mitigation strategies.  </li> </ul> Tactical Implementation   <ul> <li>Prepare, review, and submit regulatory documents for early and late-phase clinical programs (e.g., INDs, CTAs, amendments).  </li> <li>Coordinate and oversee the preparation of technical content, including CMC, non-clinical, and clinical sections of regulatory submissions.  </li> <li>Manage timelines and ensure regulatory milestones are met.  </li> <li>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.  </li> <li>Contribute to department infrastructure development by initiating processes targeted towards efficiency, quality, compliance and collaboration.  </li> </ul> Regulatory Interactions   <ul> <li>Act as a primary contact for regulatory authorities (e.g., FDA, EMA) for early and/or late-phase development programs.  </li> <li>Plan and participate in meetings with regulatory agencies, preparing briefing packages, and coordinating follow-ups.  </li> <li>Monitor and interpret regulatory guidelines and communicate implications to internal stakeholders.  </li> </ul> Cross-Functional Collaboration   <ul> <li>Work closely with research, development, CMC, and quality teams to ensure seamless regulatory support.  </li> <li>Provide regulatory input during protocol development, study design, and data interpretation.  </li> <li>Train and mentor team members on regulatory processes and requirements.  </li> </ul> Qualifications <ul> <li>Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree (PhD, PharmD, MS) preferred.  </li> <li>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.   </li> <li>Demonstrated experience in preparing and submitting regulatory filings (e.g., INDs, CTAs).  </li> </ul> Knowledge and Skills <ul> <li>In-depth knowledge of regulatory requirements and guidelines (FDA, EMA, ICH, etc.).  </li> <li>Proven ability to manage multiple projects and priorities in a fast-paced environment.  </li> <li>Strong interpersonal and communication skills, with experience engaging regulatory agencies.  </li> <li>Experience with immunotherapies or biologics is highly desirable.  </li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="title">Washington State Pay Range</div><div class="pay-range">$178,219—$212,873 USD</div></div></div><div class="content-conclusion">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: <a href="https://immunome.box.com/s/bopxukipfidxjscs4bjxt75f90bvpppk" target="_blank">E-Verify Participation Poster</a> | <a href="https://immunome.box.com/s/r51g9subw1wqni9xkutbl6up635sjr8e" target="_blank">Right to Work Poster (English)</a> | <a href="https://immunome.box.com/s/r3ekbimwh988my9vzl76tnlbg60zvh9u" target="_blank">Right to Work Poster (Spanish)</a>.</div>

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