Senior Director, Global Regulatory Lead

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 with a leadership team experienced in 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 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 toward achievement of program objectives for complex and/or multiple projects. 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. Responsibilities Regulatory Strategy Development: Define and implement global regulatory strategies that adapt to changing regulatory and business needs. Cross-Functional Leadership: Communicate key developments to project teams and stakeholders, anticipate risks and devise solutions, lead the Global Regulatory Team, and collaborate with regional regulatory leads and vendors to ensure compliance with local regulations for global submissions. Stakeholder Communication: Communicate effectively with internal and external partners, advocate for regulatory positions in governance and cross-functional committees, identify regulatory risks and opportunities, and develop strategies to mitigate risks and enhance success rates. Regulatory Submission Oversight: Ensure timely preparation and submission of regulatory submissions (e.g., INDs, BLAs, NDAs) while maintaining compliance with regional and global requirements; act as the primary contact with global health authorities and lead FDA meetings; monitor industry trends and regulatory changes, adapting strategies to mitigate impacts on product development. Qualifications Bachelor’s degree in a 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. Experience developing oncology therapeutics is strongly preferred. Knowledge and Skills 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. Comprehensive and disciplined approach to regulatory risk management and compliance in the oncology therapeutic area. Highly collaborative self-starter and team player who fosters open communication and cooperation among stakeholders. Outstanding communication, analytical, organizational and time management skills. Ability to work with small teams, under pressure, and to adapt to evolving scenarios and tight deadlines. Detail-oriented yet flexible; able to manage multiple projects and timelines and rapidly adjust priorities as needed. Washington State Pay Range

$226,000 - $270,000 USD