Director, Clinical Operations

Summittherapeutics; Menlo Park (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a Director of Clinical Operations to lead clinical trials across multiple studies. This pivotal role requires a seasoned professional with over 10 years of experience in global clinical trial management, showcasing strong leadership and project management skills. The Director will oversee the execution of clinical trials, ensuring compliance with regulatory standards while managing budgets and timelines. This is an exciting opportunity to contribute to groundbreaking clinical research in a dynamic and collaborative environment, where your expertise will drive key study milestones and enhance patient outcomes.

Qualifications

• 10+ years of experience in managing global clinical trials.
• Strong leadership and matrix management skills required.

Responsibilities

• Oversee execution of phase 1-3 clinical trials and manage vendors.
• Lead cross-functional study team and coordinate study management activities.

Skills

Clinical Trial Management

Project Management

Cross-Functional Leadership

Problem-Solving Skills

Interpersonal Skills

Negotiation Skills

Communication Skills

Education

BA/BS in Scientific/Medical Field

Tools

EDC

CTMS

MS Office Suite

Job description

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; contribute 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.
• Significant experience with cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activities.
• 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.
• Work in a fast-paced, demanding and collaborative environment.