Job Title: Director, Clinical Operations
Department: Clinical Operations
Overview of Role:
The 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 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.
- All other duties as assigned.
Experience, Education and Specialized Knowledge and Skills:
- BA/BS required; in 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.
- Strong project management experience and skills is preferred.
- Willing to travel domestically and internationally up to 20% of the time.
- Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations.
- Strong interpersonal, negotiation, influencing, problem-solving skills.
- Excellent written and verbal skills required.
- 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.
- Work in a fast-paced, demanding and 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.
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