---
title: 'Senior Director, Regulatory Affairs at Summit Therapeutics'
canonical: 'https://feeny.ai/job/senior-director-regulatory-affairs-summit-therapeutics-united-states-t8mj3aqfkbgx'
type: 'job'
last_seen: '2026-09-11'
---

# Senior Director, Regulatory Affairs at Summit Therapeutics

- **Company:** Summit Therapeutics
- **Location:** United States
- **Compensation:** $203k–$253k
- **Work type:** remote
- **Posted:** 2026-08-18
- **Last confirmed live:** 2026-09-11
- **Apply:** https://job-boards.greenhouse.io/summittherapeutics/jobs/4372636009

## Job description

About Summit:

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:

Non-small Cell Lung Cancer (NSCLC)

- HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

- HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

- HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

- HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role:

The Senior Director of Regulatory Affairs is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies as well as providing regulatory leadership for planning and execution of subsequent global marketing applications (BLA/MAA) for product(s) in the oncology therapeutic area.

Role and Responsibilities:

- Leads global regulatory strategies for assigned products/indications through all phases of development.
- May be asked to support Regulatory Affairs as relates to development collaborations and/or partnerships and be the primary point of contact for Summit regulatory to ensure success of partner IND/CTA requirements for studies sponsored by partner
- Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers, to include development of tumor landscape assessment to inform evolving development strategy.
- Advises management and cross-functional team members of the effect of current or proposed relevant laws, regulations, guidelines, and standards, etc.
- May lead the Labeling Regulatory Team for given product(s)/indication(s)
- Demonstrates excellent understanding of drug development and leadership behaviors consistent with level
- Accountable for ensuring that corporate goals are met with respect to assigned projects
- Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for other regulatory members
- May have direct reports and contributes to the performance management for other RA team members
- May advance the organization's goals by participating and taking leadership roles in professional associations, industry, and trade groups as appropriate
- Follows budget allocations

Experience, Education and Specialized Knowledge and Skills:

- Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject; Masters or Doctorate preferred
- Minimum of 10+ years' experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU, Japan, or China
- Experience and direct involvement as related to marketing/license applications (e.g., BLA, NDA, MAA)
- Requires drug development experience in US & EU
- Minimum of 5+ years of proven experience in a strategic leadership role with strong project management skills
- Experience working in a cross-functional environment with multiple stakeholders and influencing cross-functional teams
- Experience interfacing with major government regulatory authorities
- Strong communication and proactive negotiation skills
- Communicate effectively and articulate complex ideas in an easily understandable way
- Ability to successfully work in a fast-paced, demanding and collaborative environment
- Travel up to approximately 5%

This is the pay for this position

Pay Transparency $203,000—$253,000 USD

Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

## About Summit Therapeutics

## Company Overview
- **One-liner**: Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on discovering, developing, and commercializing novel bispecific antibody therapies, with its lead candidate ivonescimab targeting PD-1 and VEGF for multiple solid tumors.
- **Entity Type**: Public (NASDAQ: SMMT)
- **Headquarters**: Miami, Florida, USA (with additional offices in Palo Alto, CA; Princeton, NJ; Oxford, UK; and Dublin, Ireland)
- **Founded**: 2003
- **Founders**: Not publicly disclosed on the company website; the company was founded in 2003.

## Core Business
- **Primary industry**: Biopharmaceuticals / Oncology
- **Target customers**: B2B (healthcare providers, patients, and caregivers) with a focus on resolving serious unmet medical needs in oncology
- **Mission statement**: "To resolve serious, unmet medical needs for the betterment of overall human health." [smmttx.com](https://smmttx.com/company/about-us/default.aspx)

## Products & Services
- **Ivonescimab (SMT112)**: A novel, potential first-in-class investigational bispecific antibody targeting both PD-1 and VEGF. It is designed to combine immunotherapy (PD-1 blockade) with anti-angiogenesis (VEGF blockade) into a single molecule. Currently being studied in several global Phase 3 clinical trials for non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and head and neck squamous cell carcinoma (HNSCC). Licensed from Akeso, Inc. (HKEX: 9926.HK) for territories including the U.S., Canada, Europe, Japan, Latin America, the Middle East, and Africa. [smmttx.com](https://smmttx.com/pipeline/default.aspx)

## Market Standing
- **Valuation/Market Cap**: Approximately $2.7 billion (as of recent data) [linkedin.com](https://www.linkedin.com/company/summit-therapeutics)
- **Key Metric**: Annual revenue of approximately $705,000 (reported). The company is pre-commercialization and heavily investing in R&D. Total funding raised since IPO (2015) is not disclosed, but the company has a strong cash position from equity offerings.
- **Notable Investors/Partners**: Akeso, Inc. (key licensing partner for ivonescimab). The company is publicly traded with institutional and retail investors.
- **Growth Signals**: 
  - Headcount grew 72.5% year-over-year to 244 employees. [linkedin.com](https://www.linkedin.com/company/summit-therapeutics)
  - Multiple global Phase 3 trials actively recruiting (HARMONi, HARMONi-3, HARMONi-7, HARMONi-GI3, ILLUMINE).
  - Over 4,000 patients have been treated with ivonescimab across all clinical trials globally. [smmttx.com](https://smmttx.com/pipeline/default.aspx)
  - Achieved Great Place to Work® Certification. [smmttx.com](https://smmttx.com/careers/careers-overview/default.aspx)

## Competitive Advantages
- **Novel Mechanism**: Ivonescimab is a first-in-class bispecific antibody targeting both PD-1 and VEGF simultaneously, potentially offering superior efficacy and fewer side effects compared to combination therapies.
- **Speed and Execution**: The company emphasizes "high-speed execution in commercialization" and has rapidly initiated multiple Phase 3 trials.
- **Global Reach**: Licensed territories cover major markets (U.S., Canada, Europe, Japan, Latin America, Middle East, Africa) with a strong partner (Akeso) in the rest of the world.
- **Strong Balance Sheet**: With a $2.7B market cap and public listing, the company has access to capital markets to fund its pipeline.

## Strategic Focus
- **Current priorities**: Advancing ivonescimab through Phase 3 clinical trials across multiple solid tumor indications (NSCLC, CRC, HNSCC), with the goal of regulatory approval and commercialization.
- **Future direction**: Expanding the pipeline into additional solid tumors and leveraging the bispecific platform for future therapies. The company is focused on becoming a leading oncology player.
- **Near-term milestones**: Data readouts from ongoing Phase 3 trials, potential regulatory submissions, and building commercial infrastructure.

## Why Work Here
- **Culture**: The company has achieved Great Place to Work® Certification, indicating a positive, supportive, and fulfilling work environment. Core values include Commitment to People, Integrity, Passion for Excellence, Purposeful Urgency, Accountability, and Collaboration. [smmttx.com](https://smmttx.com/careers/careers-overview/default.aspx)
- **Work Environment**: Fast-paced, high-energy atmosphere focused on innovation and collaboration. The company emphasizes "making a significant difference in patients’ lives."
- **Benefits (U.S.)**: 
  - 401(k) with 6% employer match
  - Employee Stock Purchase Plan (ESPP) with 15% discount up to the annual federal limit
  - Flexible Spending Account
  - Commuter Benefit
  - Onsite lunch provided
- **Benefits (U.K.)**: 
  - Private Medical Insurance
  - Employee Assistance Program
  - Life Assurance Policy
  - Company Pension Contributions
  - ESPP
- **Remote/Hybrid Policy**: Not explicitly stated, but multiple office locations suggest a hybrid or on-site presence is expected for many roles.
- **Open Roles**: 25 active job postings (as of recent data) including Senior Director of Sales Operations, Clinical Scientists, Medical Science Liaisons, and Drug Product MSAT roles. [greenhouse.io](https://job-boards.greenhouse.io/summitherrapeutics)
- **Headcount Growth**: 72.5% year-over-year growth signals a scaling organization with opportunities for career advancement.

## Sources
1. [smmttx.com - About Us](https://smmttx.com/company/about-us/default.aspx)
2. [smmttx.com - Investor Relations Overview](https://www.smmttx.com/overview/default.aspx)
3. [smmttx.com - Pipeline](https://smmttx.com/pipeline/default.aspx)
4. [smmttx.com - Careers Overview](https://smmttx.com/careers/careers-overview/default.aspx)
5. [linkedin.com - Summit Therapeutics Company Page](https://www.linkedin.com/company/summit-therapeutics)
6. [greenhouse.io - Summit Therapeutics Careers](https://job-boards.greenhouse.io/summitherrapeutics)

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