---
title: 'Senior Director/Executive Director, Global Regulatory Lead at Immunome, Inc.'
canonical: 'https://feeny.ai/job/senior-director-executive-director-global-regulatory-lead-immunome-inc-united-0tnxch6gg7y0'
type: 'job'
last_seen: '2026-09-12'
---

# Senior Director/Executive Director, Global Regulatory Lead at Immunome, Inc.

- **Company:** Immunome, Inc.
- **Location:** United States
- **Compensation:** $259k–$396k
- **Work type:** remote
- **Posted:** 2025-11-13
- **Last confirmed live:** 2026-09-12
- **Apply:** https://job-boards.greenhouse.io/immunomeinc/jobs/4982640008

## 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 accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. 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 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.
- Ability to travel occasionally to our Bothell, WA headquarters.

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 $259,080—$396,201 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](https://immunome.box.com/s/bopxukipfidxjscs4bjxt75f90bvpppk) | https://immunome.box.com/s/r51g9subw1wqni9xkutbl6up635sjr8e | https://immunome.box.com/s/r3ekbimwh988my9vzl76tnlbg60zvh9u.

## About Immunome, Inc.

## Company Overview
- **One-liner**: Immunome is a clinical-stage oncology company developing first-in-class and best-in-class targeted cancer therapies, with a primary focus on antibody-drug conjugates (ADCs).
- **Entity Type**: Public (Nasdaq: IMNM)
- **Headquarters**: Bothell, Washington, United States
- **Founded**: The company was formed through a merger of Morphimmune and Immunome in October 2023.
- **Founders**: The company is led by Clay Siegall, Ph.D. (Chairman, CEO, and President), who co-founded Seagen. The original Immunome entity was founded earlier, but the current company structure dates to the 2023 merger.

## Core Business
- Primary industry/industries: Biotechnology, Oncology, Drug Discovery & Development
- Target customers: Patients with cancer, healthcare providers, and clinical trial sites. The company is a B2B/B2C entity in the healthcare and life sciences space.
- Mission or purpose statement: "Our mission is to improve outcomes for cancer patients by advancing and expanding a portfolio of first-in-class and best-in-class therapeutic candidates." [immunome.com](https://immunome.com/)

## Products & Services
- **Varegacestat (formerly AL102)**: A late-clinical stage gamma secretase inhibitor for the treatment of desmoid tumors. The company submitted a New Drug Application (NDA) to the U.S. FDA in April 2026. [investors.immunome.com](https://investors.immunome.com/)
- **IM-1021**: A ROR1-targeted antibody-drug conjugate (ADC) currently in a Phase 1 trial.
- **IM-3050**: A FAP-targeted radioligand which received IND clearance in Q1 2025.
- **Preclinical ADC Pipeline (IM-1617, IM-1340, IM-1335)**: ADCs pursuing undisclosed targets with expression in multiple solid tumors. IM-1617 had its first patient dosed in a Phase 1 trial in June 2026. [investors.immunome.com](https://investors.immunome.com/)

## Market Standing
- **Valuation/Market Cap**: Not publicly available in the search results. As a public company, this fluctuates. (Check recent filings for current data).
- **Key Metric**: The company is pre-revenue (clinical-stage) and has raised significant capital. Since the 2023 merger, CEO Clay Siegall has raised $355 million in equity financings. [immunome.com](https://immunome.com/about/)
- **Notable Investors/Partners**: The company is publicly traded. Key leadership previously worked at Seagen (acquired by Pfizer for $43 billion).
- **Growth Signals**: The company is rapidly advancing its pipeline. Key milestones include the NDA submission for varegacestat, first patient dosed for IM-1617, and positive Phase 3 data presented at ASCO 2026. The company currently lists 32 open positions on its careers page, indicating strong hiring momentum. [job-boards.greenhouse.io](http://job-boards.greenhouse.io/immunomeinc)

## Competitive Advantages
- **World-Class Leadership**: The executive team, led by Seagen co-founder Clay Siegall, has deep experience in designing, developing, and commercializing blockbuster ADCs (ADCETRIS, PADCEV, TIVDAK, TUKYSA). [immunome.com](https://immunome.com/about/)
- **Proprietary ADC Platform**: A systematic, data-driven process for optimizing antibodies, linkers, and payloads to create differentiated ADCs. [immunome.com](https://immunome.com/)
- **Near-Term Catalyst**: The NDA submission for varegacestat provides a potential near-term commercial opportunity.
- **Strong Financial Backing**: Raised $355M in equity since the merger, providing a solid runway for pipeline advancement.

## Strategic Focus
- **Advancing the Pipeline**: The primary focus is on executing clinical trials for varegacestat (Phase 3), IM-1021 (Phase 1), and IM-3050 (Phase 1), and advancing preclinical ADCs into the clinic.
- **Regulatory Filing**: Successfully navigating the FDA NDA submission and potential approval for varegacestat.
- **Discovery & Expansion**: Using their ADC discovery platform to generate new candidates and identify and acquire targeted oncology assets to expand the portfolio. [immunome.com](https://immunome.com/about/)

## Why Work Here
- **Mission-Driven**: The work directly impacts the lives of cancer patients, with a stated goal of developing transformative therapies. [immunome.com](https://immunome.com/about/)
- **High-Impact Team**: Opportunity to work with "some of the brightest and most experienced minds in ADC development," including leaders who have brought multiple drugs to market. [immunome.com](https://immunome.com/careers/)
- **Growth Stage**: With 32 open roles, the company is in a rapid growth phase, offering significant career advancement opportunities. [job-boards.greenhouse.io](http://job-boards.greenhouse.io/immunomeinc)
- **Comprehensive Benefits**: Includes 100% company-paid medical premiums for employees, a 401(k) with employer match, paid parental leave, and a week-long winter break. [immunome.com](https://immunome.com/careers/)
- **Location & Culture**: Based in Bothell, WA. The company describes a culture of "innovative, collaborative environment where employees are empowered to do their best work." [immunome.com](https://immunome.com/careers/)

## Sources
1. [Immunome Official Website](https://immunome.com/)
2. [Immunome About Page](https://immunome.com/about/)
3. [Immunome Investor Relations](https://investors.immunome.com/)
4. [Immunome Careers Page](https://immunome.com/careers/)
5. [Immunome Jobs on Greenhouse](http://job-boards.greenhouse.io/immunomeinc)

## Other roles at Immunome, Inc.

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- [Senior In-House Clinical Research Associate](https://feeny.ai/job/senior-in-house-clinical-research-associate-immunome-inc-bothell-washington-xd757hs9sz89) — Bothell Washington, United States
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