Immunome, Inc.

Senior Director, Global Regulatory Lead

US Remote · Director

Sponsorship not specified$226k-$270kDetected 7 days ago

Stakeholder ManagementFDA RegulatoryLeadershipCommunicationTime ManagementMentoringMicrosoft OfficeRegulatory Affairs

About the role

You will work collaboratively across teams to ensure compliance and alignment with corporate objectives, driving the regulatory success of our products in development and throughout their life cycle.
This position will report to the Vice President, Regulatory Affairs.
Washington State Pay Range $226,000 - $270,000 USD E/E/O Immunome, Inc. is an equal opportunity employer.

Define and implement global regulatory strategies that adapt to changing regulatory and business needs.
Lead the Global Regulatory Team, fostering a high-performance culture through coaching and mentoring.
Collaborate with regional regulatory leads and vendors to ensure compliance with local regulations for global submissions.
Communicate effectively with internal and external partners, advocating for regulatory positions in governance and cross-functional committees.
Identify regulatory risks and opportunities, developing strategies to mitigate risks and enhance success rates.
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies.
As the Global Regulatory Lead at Immunome, you will be the key decision-maker responsible for the development and execution of innovative global regulatory strategies for our therapeutic portfolio to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.

Bachelor's degree in relevant scientific discipline.
A minimum of 10 years of experience in global regulatory affairs in the pharmaceutical / biotechnology industry, or equivalent experience.
Proven success in leading regulatory submissions and obtaining approvals in major markets.
Ability to travel monthly to Bothell, Washington headquarters.
Knowledge and Skills
Has a comprehensive and disciplined approach to regulatory risk management and compliance through deep expertise and understanding of the oncology therapeutic area.
Experience and passion to work with small teams, ability to work comfortably under pressure under evolving scenarios and tight deadlines.
Experience developing oncology therapeutics is strongly preferred.
Direct experience leading regulatory submissions, health authority meetings and interactions with in-depth knowledge of the internal operations and outlook of the FDA, EMA and other global health authorities.
Highly collaborative self-starter and team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
Outstanding communication, analytical, organizational and time management skills.
Detail-minded yet flexible work style
manage multiple projects and timelines simultaneously, and rapidly change priorities based on business needs.
Washington State Pay Range

Act as the primary contact with global health authorities and lead FDA meetings.

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.