Associate Director, Clinical Operations

Our Mission:

To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.

We have in-licensed Ivonescimab, which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. We plan to initiate phase-III clinical studies.

Will be require relocation to the Miami Headquarters

Overview of Role:

The Associate Director / Director / Sr. Director will serve as a cross-functional study team lead for the clinical development program, responsible for delivering all clinical trial operational activities across multiple studies for Summit Therapeutics. This role should demonstrate strong matrix management skills, confidence in working independently, and have proven ability to champion a team to deliver on key study milestones. In addition, the Associate Director / Director / Sr. Director will be responsible for assisting in study design, planning, and execution of clinical trials while operating within budget and per established 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: Establish and 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.), monitoring study status across internal functions and external vendors, anticipating and 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, as required.

• Study Site Management: Cultivate and maintain strong 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: Maintain oversight 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; identify and 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.

• CRO and Vendor Management: Drive CRO and vendor selection process, manage CRO and vendor performance, mitigate issues (quality, timeline, budget), and escalate appropriately.

• Inspection Readiness: Oversee and maintain clinical trial master files and other study documents to ensure inspection readiness at all times.

• Line Management: Serve as manager and mentor to junior members of the Clinical Operations team and help them reach their performance and career development goals.

• 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.

• Recruit, hire and develop clinical operations talent to assist in study execution.

Experience, Education and Specialized Knowledge and Skills:

• BA/BS required; in a scientific/medical field preferred.

• At least 8+ years of experience in managing global clinical trials at all stages of development.

• Experience in oncology 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 experience with cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activities.

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

• Strong vendor management experience required.

• 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, regulatory inspections and/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 skills required.

• 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, accuracy and confidentiality.

• Clear and concise oral and written communication skills

• Excellent organizational skills

• Critical thinking, problem solving, ability to 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.

• Prioritize conflicting demands.

• Work in a fast-paced, demanding and collaborative environment.

The pay range for this role is $158,000 to $188,000 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. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with a 15% discount up to the federal limit, flexible spending account among other benefits 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 human resources department to obtain prior written authorization before referring any candidates to Summit.