Associate Director, Clinical Operations

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. Summits 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.

Summits team is inspired to touch and help change lives through Summits 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 Chinas 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:

• Bachelors 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.

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 Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics 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.