Senior Director, Global Regulatory Lead

Immunomeinc; Bothell (WA); On-site; USD 226,000 - 270,000; Full time

Job summary

Immunome, Inc. in Bothell, WA, is seeking a Global Regulatory Lead to shape and execute regulatory strategies across its oncology portfolio.

You will collaborate with cross‑functional teams to navigate global submissions (INDs, BLAs, NDAs), manage health authority interactions, and lead a high‑performing regulatory group reporting to the VP of Regulatory Affairs. This role requires a minimum of 10 years in global regulatory affairs, oncology experience preferred, and a proven track record of

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.

Responsibilities

• Define and implement global regulatory strategies for multiple projects.
• Communicate key developments to project teams and stakeholders.
• Lead the Global Regulatory Team and mentor staff.
• Collaborate with regional regulatory leads and vendors for global submissions.
• Interact with health authorities and lead FDA meetings.
• Identify regulatory risks and develop mitigation strategies.
• Oversee timely preparation and submission of regulatory documents.

Skills

Regulatory leadership

Cross-functional collaboration

Communication skills

Regulatory risk management

Team leadership

Strategic thinking

Education

Bachelor's degree in a relevant scientific discipline

Job description

Company Overview

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.

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 towards 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, ensuring alignment and sound judgment.
• Anticipate risks and devise solutions, understanding the likelihood of technical success for proposed strategies.

Team Leadership

• 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.

Stakeholder Communication

• Communicate effectively with internal and external partners, advocating for regulatory positions in governance and cross‑functional committees.

Risk Management

• Identify regulatory risks and opportunities, developing 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.

Continuous Improvement

• 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.
• Has a comprehensive and disciplined approach to regulatory risk management and compliance through deep expertise and understanding of the oncology therapeutic area.
• 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.
• Experience and passion to work with small teams, ability to work comfortably under pressure under evolving scenarios and tight deadlines.
• Detail‑minded yet flexible work style; manage multiple projects and timelines simultaneously, and rapidly change priorities based on business needs.

Washington State Pay Range: $226,000 – $270,000 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.

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).