Director, Clinical Operations

Summit Therapeutics Plc•Princeton, NJ

3d•$190,000 - $230,000•Hybrid

About The Position

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.

Requirements

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
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

Nice To Haves

Experience in rare/orphan disease areas is preferred

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.
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