Senior Director, Clinical Operations

Menlo Park, CA - USA

Yearly Salary: $ 238000 - 265000

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Overview of Role:

The Senior Director of Clinical Operations 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 addition the Senior 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
At least 15 years of experience in managing global clinical trials at all stages of development
Strong vendor management experience required
Experience in oncology trial management is strongly 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 organizing and/or participating in specific study-related advisory committees (e.g. steering committee data monitoring committees adjudication committees)
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
Strong attention to detail with the ability to lead and function as rational and humble problem solver
Leadership experience with the ability to inspire excellence in themselves and those around them
High-quality executor; ability to execute against goals and milestones with quality precision and speed

The pay range for this role is $238000-$265000 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.

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 Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Required Experience:

Exec

Overview of Role:The Senior Director of Clinical Operations 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 ...

Overview of Role:

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
At least 15 years of experience in managing global clinical trials at all stages of development
Strong vendor management experience required
Experience in oncology trial management is strongly 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 organizing and/or participating in specific study-related advisory committees (e.g. steering committee data monitoring committees adjudication committees)
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
Strong attention to detail with the ability to lead and function as rational and humble problem solver
Leadership experience with the ability to inspire excellence in themselves and those around them
High-quality executor; ability to execute against goals and milestones with quality precision and speed

Required Experience:

Exec

Key Skills

Employee Relations
Employee Evaluation
Management Experience
Profit & Loss
Conflict Management
Operations Management
Project Management
Budgeting
Leadership Experience
Supervising Experience
Leadership management
Financial Planning

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About Company

Summit Therapeutics Sub

Summit is committed to leadership in resolving serious, unmet medical needs in oncology for the betterment of overall HUMAN HEALTH. Stifel Fireside Chat Patients & Caregivers Summit Latest News Committed to Optimizing Human Health Summit Therapeutics Inc. is a biopharmaceutical oncolo ... View more

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