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
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
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 [email protected] 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.
Skills Required
- Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or related field
- 10+ years direct clinical trial management experience overseeing Phase II/III international oncology clinical trials
- Experience managing CROs, vendors, and strategic partners including governance, performance metrics, and risk management
- Knowledge of GCP and ICH guidelines and ability to ensure regulatory compliance and inspection-readiness
- Experience maintaining Trial Master File (TMF) and completing TMF quality reviews
- Budget management and oversight of vendor costs, contracts, and change orders
- Proven people management experience mentoring CTMs, CRAs, and clinical operations team members
- Ability to travel internationally (up to 20%)
What We Do
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs. To identify and control promising product candidates based on exceptional scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner, and to engage commercialization and/or development partners when appropriate. We accomplish this by building a team of world class professional scientists and business administrators that apply their experience and knowledge to this mission. Team Summit exists to pose, strategize, and execute a path forward in medicinal therapeutic health care that places Summit in a well-deserved, top market share, leadership position. Team Summit assumes full responsibility for stimulating continuous expansion of knowledge, ability, capability, and well-being for all involved stakeholders and highly-valued shareholders. Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Miami, Florida, and we have additional offices in Palo Alto, California, Princeton, New Jersey, Oxford, UK, and Dublin, Ireland.
