---
title: 'Associate Director, CMC / Quality Project Management at Summit Therapeutics'
canonical: 'https://feeny.ai/job/associate-director-cmc-quality-project-management-summit-therapeutics-princeton-0bc35yd129z5'
type: 'job'
last_seen: '2026-11-06'
---

# Associate Director, CMC / Quality Project Management at Summit Therapeutics

- **Company:** Summit Therapeutics
- **Location:** Princeton, NJ
- **Compensation:** $174k–$204k
- **Posted:** 2026-11-06
- **Last confirmed live:** 2026-11-06
- **Apply:** https://job-boards.greenhouse.io/summittherapeutics/jobs/4483207009

## 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.

The Associate Director, Project Management (CMC, Quality) is an individual contributor position that will play a critical role in driving the success of Summit programs and with prioritized focus in CMC, Supply, Quality and Business activities.  Role will provide CMC / Quality program leadership in cross-functional team settings and will help build the infrastructure, tools and processes contributing to the success of Program Management department. Provides strategic and operational leadership for CMC and Quality deliverables across the biologics development lifecycle—from early clinical phases through BLA submission and post‑approval changes. Working within a matrixed environment, you will collaborate across Process Development, Analytical Development, Quality, Regulatory Affairs, Manufacturing, external partners (CDMOs/CROs) to deliver high-quality submissions and commercialization readiness. If you enjoy the excitement and intensity of senior leader engagements where assignments may deeply embed you with targeted functions or teams, then this is the role for you!

Role and Responsibilities:

- Cross-functional Collaboration and CMC Leadership
- Represent the Program Management department in cross-functional teams with clinical development, non-clinical and/or regulatory focus
- Develop and maintain detailed CMC submission plans, timelines, and risk mitigation strategies for BLA and other regulatory filings
- Prepare high-impact presentations, decision memos, and status reports for senior management and governance forums
- Implement and refine program tools, workflows, and processes to enhance efficiency, transparency, and quality of CMC operations
- Strategic Responsibilities:
- Ensure alignment in CMC strategy for early stage IND/IMPD and late-stage biologics suitable for BLA/ MAA filings (including characterization, control strategy, comparability, stability, regulatory expectations)
- Ensure alignment of CMC deliverables with project milestones and product target profile through data-driven and risk-based decision-making
- Engage in cross-functional governance and steering committees to influence and guide program direction.
- Project Management
- Maintain decision-quality approaches within assigned areas with options and trade-off assessments
- Actively identify, track and mitigate risks, to include opportunity creation that may accelerate project success
- Develop, implement and maintain CMC plans for assigned activities, to include scenario planning, dashboards, reports and timelines that integrate into overall Program Plans. Communicate CMC plans to cross-functional team and leadership
- Provide clinical supply inputs to development scenarios, clinical supply forecast, vendor plans, and governance decisions, balancing patient needs, operational feasibility, cost, inventory, expiry, and supply risk.
- Support clinical trial start-up and execution by tracking critical supply dependencies and ensuring timely escalation of issues that could affect first-patient-in, site activation, enrollment, dosing continuity.
- CDMO/CMO Oversight & External Collaboration Management
- Serve as the primary CMC PM interface for CDMOs/CMOs performing drug substance, drug product, and analytical testing.
- Monitor CDMO performance against KPIs (batch production and release, deviation closure, CAPA effectiveness) and escalate risks proactively.
- Serve as the CMC/Supply PM liaison for external study collaborations, integrating partner assumptions and timelines into internal program plans; facilitate cross-company risk reviews, scenario assessments, issue resolution, and governance decisions to maintain alignment on study readiness and continuity of clinical supply.
- Lead CMC and clinical supply program management for collaborative clinical studies with external partners, establishing joint plans, governance cadence, roles, decision rights, milestones, dependencies, deliverables, and escalation pathways aligned with contractual obligations and overall program objectives.
- Limited travel may be required depending on assigned activities or projects, plus flexibility for global virtual meetings in different time zones. Ability to travel globally may be needed, including EU and meeting Chinese Visa requirements.
- All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

- Education: Bachelor’s degree in life sciences, chemistry, engineering, or related field required; advanced degree (MS, PharmD, PhD, MBA) desirable.
- Experience: 8+ years in pharmaceutical/biotech industry, with substantial experience in CMC development, late-stage biologics, and regulatory filing preparation (BLA, MAA)
- Leadership: Proven success leading global, matrixed, cross-functional teams in a regulated environment
- Preferred Language: Professional proficiency in Mandarin is strongly preferred to facilitate communication with overseas collaborators.
- Project Management: Strong skills in integrated project planning (PMP certified), risk management, resource allocation, and budget oversight. Experience with tools like Smartsheet, MS Project, Power BI, Office Timeline etc., is beneficial.
- Prior pharmaceutical (drug development) experience required, late-stage to commercialization phase experience and biologics preferred
- Prior oncology experience in late-stage development and understanding of GMP, manufacturing and global regulatory supply chains preferred
- Proficient user of MS Office suite (e.g., PowerPoint, Word, Excel, Project), experience using electronic document management systems, document review tools and can quickly build presentations for leaders/teams
- Excellent communicator in public-speaking, meeting facilitation and email communication
- Ability to excel in a fast-paced, demanding and diverse environment.

This is the pay for this position

Pay Transparency $174,000—$204,000 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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