Associate Director, Regulatory Affairs Bothell, Washington, United States - Immunome : Job Details

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.

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 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

$163,929 - $190,534 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.

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