Hybrid Director, Clinical Operations

at Summit Therapeutics, Inc.

• Job title: Director, Clinical Operations
• Job type: Full Time
• Experience level: Lead
• Salary: $190,000 - $230,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Princeton, United States

About the role

• Director of Clinical Operations overseeing phase 1-3 clinical trials in oncology at Summit Therapeutics. Responsible for managing cross-functional teams and ensuring compliance with regulations.

Responsibilities

• 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
• 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
• 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
• 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
• 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.
• Support clinical and non-clinical supplies planning for trial execution.

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
• 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 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