Director Clinical Operations
Director Clinical Operations
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$ 190000 - 230000
1 Vacancy
Job Description
Overview of Role:
The Director will serve as a crossfunctional 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 of clinical trials while operating within budget and per established timelines regulatory and quality standards.
Role and Responsibilities:
- Study : Oversee and manage the of one or more phase 13 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 crossfunctional study team development of an overall study 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 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 nonclinical supplies planning for trial .
- Truth Seekers who are detailed rational and humble problem solvers
- Individuals Who Inspire Excellence in themselves and those around them
- Highquality executors who execute against goals and milestones with quality precision and speed
- 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 startup through closeout 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 crossfunctional 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 studyrelated 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 submissionready eTMF regulatory inspections and/or inspectionreadiness 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 multitask in a dynamic and fastpaced environment
- Strong interpersonal negotiation influencing problemsolving 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 multitask and manage timesensitive and highly confidential documents.
- Communicate effectively and articulate complex ideas in an easily understandable way
- Prioritize conflicting demands.
- Work in a fastpaced demanding and collaborative environment
The pay range for this role is $190000$230000 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 atto obtain prior written authorization before referring any candidates to Summit.
Required Experience:
Director
Employment Type
Full-Time
