--- title: 'Associate Director, Clinical Operations at Summit Therapeutics' canonical: 'https://feeny.ai/job/associate-director-clinical-operations-summit-therapeutics-miami-fl-princeton-2brsr2f9wz9h' type: 'job' last_seen: '2026-09-11' --- # Associate Director, Clinical Operations at Summit Therapeutics - **Company:** Summit Therapeutics - **Location:** Miami FL Princeton, NJ - **Compensation:** $174k–$205k - **Posted:** 2026-08-12 - **Last confirmed live:** 2026-09-11 - **Apply:** https://job-boards.greenhouse.io/summittherapeutics/jobs/4364379009 ## 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. ## ASSOCIATE DIRECTOR, CLINICAL OPERATIONS Location: Princeton, NJ or Miami, FL ONSITE Overview of Role: The Associate Director, Clinical Operations provides operational leadership for clinical trial execution, overseeing the clinical operations team and vendor performance. This role ensures effective study delivery through cross functional collaboration, proactive risk management, and strong execution oversight. This role leads vendor strategy and oversight ensuring external partners deliver against scope, timelines, quality expectations, and operational objectives. The ideal candidate thrives in a fast-paced, entrepreneurial environment, demonstrates exceptional operational leadership, and possesses strong business acumen with an understanding of the competitive landscape, capital allocation, and value creation throughout drug development. Role and Responsibilities: - Oversees the clinical operational strategy, planning, and execution of one or more global clinical trials. - Ensures internal clinical and external teams deliver on time, within budget and in compliance with GCP, ICH guidelines, applicable regulations and are always inspection-ready. - Drafts, reviews and approves internal and external study-related plans, processes, and documents including Informed Consent Forms, Investigator Agreements (CTA), CRFs, CRF Guidelines, statistical/pharmacokinetic analysis plans, monitoring plans, data management plans, and safety monitoring activities. - Manages CROs, vendors, and strategic partners through robust governance, performance metrics, and risk management. - Identifies operational risks early and implement proactive mitigation strategies escalating to leadership. - Drives financial accountability through effective budget management and resource utilization. - Oversees maintenance, quality, and completeness of the Trial Master File (TMF) and ensures all TMF quality reviews are completed. - Manages CRO proposals, vendor contracts/change orders, and outsourcing strategies ensuring delivery with a focus on value and return on investment. - Partners with Finance to provide oversight of vendors costs, supporting prudent operational decisions that align with budgets and financial plans. - Oversees preparations for regulatory inspections, supports inspection management activities, and ensures the project is always inspection-ready. - Manages, mentors and provides guidance to CTMs, CRAs, and other Clinical Operations team members. - Drives continuous improvement initiatives and contributes to development of Clinical Operations processes and standards. - Represents Clinical Operations on cross-functional study teams and governance meetings. - Fosters collaboration with external partners, Regulatory Affairs, Clinical Science, Data Management, Biostatistics, Pharmacovigilance, Quality Assurance, CMC, and Commercial teams. - All other duties as assigned Experience, Education and Specialized Knowledge and Skills: - Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related areas - 10+ years of direct clinical trial management experience overseeing phase II/III international oncology clinical trials - Ability to travel internationally to visit clinical sites and study meetings. Amount will vary upon project needs (up to 20%) Preferred Experience, Education and Specialized Knowledge and Skills: - Consistently demonstrates ability to solve problems and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs - Excellent planning, leadership, communication, negotiation, and organizational skills when working with both internal and external teams. - Expert knowledge of the drug development process, ICH guidelines/GCP with a deep understanding of all phases of clinical trial execution and the ability to apply this knowledge to complex, global studies. This is the pay for this position Pay Transparency $174,000—$205,000 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) ## Other roles at Summit Therapeutics - [Senior Director, Regulatory CMC](https://feeny.ai/job/senior-director-regulatory-cmc-summit-therapeutics-united-states-qnq72sd971hr) — United States - [National Account Director, Government Payers —Medicaid](https://feeny.ai/job/national-account-director-government-payers-medicaid-summit-therapeutics-field-1sjzqhpn2hwe) — Field, United States - [Sr. Clinical Data Scientist](https://feeny.ai/job/sr-clinical-data-scientist-summit-therapeutics-palo-alto-y90jqt03ag43) — Palo Alto, CA - [Sr. Manager, Clinical Quality Assurance](https://feeny.ai/job/sr-manager-clinical-quality-assurance-summit-therapeutics-remote-0mexn4fh8bg8) - [Senior Director, Regional Marketing](https://feeny.ai/job/senior-director-regional-marketing-summit-therapeutics-princeton-nj-85z6bke8tkv2) — Princeton NJ, United States - [Senior Manager, Commercial Analytics](https://feeny.ai/job/senior-manager-commercial-analytics-summit-therapeutics-princeton-nj-s8drfzyv2fvy) — Princeton NJ, United States - [Associate Director, Regulatory Affairs](https://feeny.ai/job/associate-director-regulatory-affairs-summit-therapeutics-united-states-6v4qz21pkcxj) — United States - [Chief Commercial Officer](https://feeny.ai/job/chief-commercial-officer-summit-therapeutics-princeton-nj-y6mzyr8j1web) — Princeton NJ, United States - [Associate Director, Clinical Study Start-Up](https://feeny.ai/job/associate-director-clinical-study-start-up-summit-therapeutics-princeton-new-nemvsnpnzfdd) — Princeton New Jersey, United States - [Senior Director, Program Management](https://feeny.ai/job/senior-director-program-management-summit-therapeutics-palo-alto-california-fwf6t8kayq3v) — Palo Alto California, United States