Director, Clinical Operations

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Location: On-Site 4 days per week at our Princeton, NJ or Miami FL locations

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.
• 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 Director will serve as a cross-functional study teamleadfor the clinical development program, responsible for delivering all clinical trial operational activities across multiple studies for Summit Therapeutics. This role shoulddemonstratestrong matrix management skills, confidence in working independently, and have proven ability to champion a team todeliver onkey study milestones. In addition, the Director willbe responsible forassistingin study design, planning, and execution of clinical trials whileoperatingwithin budgetand perestablished timelines, regulatory and quality standards.

Role and Responsibilities

Study Execution: Oversee and manage the execution of one or more phase 1-3 clinical trials. Management of all clinical operations support vendors contracted for the assigned study(ies), including budgets and timelines oversight, performance management, risk management, and issue resolution

Study Planning and Management: Establishand coordinate all ongoing study management activities, including leading the cross-functional study team development of an overall study execution plan to deliver key study deliverables. Daily activities may include updating/reviewing study documents (protocols, informed consent forms, clinical study reports, site facing material, etc.),monitoringstudy status across internal functions and external vendors,anticipatingand mitigating risks within the timeline, quality, and study budget

Study Team Meetings: Lead team meetings, as assigned, both internally and with multiple vendors. Attend Project Team and/or Executive Team Meetings, asrequired

Study Site Management: Cultivate andmaintainstrong relationships with investigators and trial site administrators; Organize investigator meetings as needed; contributes to the development of abstracts, presentations, and manuscripts for studies

Clinical Trial Budgeting:Maintainoversight of clinical operations budget, including regular forecasting and internal reporting to management and finance; review vendor invoices against the scope of work and work completed to date;identifyand communicate discrepancies

Quality Control: Support the development of quality control processes and study plans to ensure that clinical activities are compliant with Good Clinical Practice and regulatory guidelines. Ensure execution of trials according to the study protocol and procedures, SOPs, ICH/GCP, FDA, EMEA, NICE, and other relevant policies and regulations

Supply Chain Management: Support clinical and non-clinical supplies planning for trial execution.

Truth Seekers, who are detailed, rational, and humble problem solvers

Individuals Who Inspire Excellence in themselves and those around them

High-quality executors, who execute against goals and milestones with quality, precision, and speed

All other duties as assigned

Experience, Education and Specialized Knowledge and Skills

BA/BSrequiredin a scientific/medical field preferred

A minimum of 10+ years of experience in managing global clinical trials at all stages of development

Experience in rare/orphan disease areas is preferred

Demonstrated ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking and reporting activities

Demonstrated successful management and oversight of CROs and other service providers

Deep understanding of clinical trial design, protocol development/ review, and running the clinical trial meetings

Significant experiencewith cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activities

Organize and/orparticipatein specific study-related advisory committees (e.g., steering committee, data monitoring committees, adjudication committees)

Experience in the management and maintenance of EDC, CTMS,IxRS, ePRO, etc.

Experience in Quality Assurance, SOP and Study Plans writing, CAPA preparation, and closure

Experience with a submission-ready eTMF, regulatoryinspectionsand/or inspection-readiness activities

Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations

Strong project management experience and skills is preferred

Demonstrate strong leadership and matrix management skills, ability to multi-task in a dynamic and fast-paced environment

Strong interpersonal, negotiation, influencing, problem-solving skills

Excellent written and verbal skillsrequired

Willing to travel domestically and internationally up to 20% of the time

Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable

Strong computer and database skills

Attention to detail,accuracyand confidentiality

Clear and concise oral and written communication skills

Excellent organizational skills

Critical thinking, problem solving, abilityto work independently.

Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.

Communicate effectively and articulate complex ideas in an easily understandable way

Work in a fast-paced,demandingand collaborative environment

The pay range for this role is $190,000-$230,000 annually. 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 [email protected] to obtain prior written authorization before referring any candidates to Summit.