Immunome, Inc.

Associate Director, Regulatory Affairs

Bothell, Washington, United States · Director

Sponsorship not specified$178k-$213kDetected 34 days ago

FDA RegulatoryResearchExperimental DesignLeadershipCommunicationCollaborationRegulatory Affairs

About the role

The successful candidate will combine hands-on expertise in regulatory affairs with a proactive approach to solving complex challenges in clinical development.
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.

Contribute to the design and execution of global regulatory strategies for early-phase development programs.
Identify and assess potential regulatory risks and develop mitigation strategies.
Prepare, review, and submit regulatory documents for early and late-phase clinical programs (e.g., INDs, CTAs, amendments).
Manage timelines and ensure regulatory milestones are met.
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.
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies.
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.

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.).
Experience with immunotherapies or biologics is highly desirable.
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.
Proven ability to manage multiple projects and priorities in a fast-paced environment.
Strong interpersonal and communication skills, with experience engaging regulatory agencies.
Washington State Pay Range
$178,219 - $212,873 USD
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).

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.
We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

This listing is sourced directly from Immunome, Inc.'s careers page and normalized into a canonical job model.