What are the responsibilities and job description for the Senior Director, Clinical Operations position at Exokeryx?
Career Opportunities with Summit Therapeutics Sub, Inc.
A great place to work.
Careers At Summit Therapeutics Sub, Inc.
Current job opportunities are posted here as they become available.
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 milestones. In 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; 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 :
The pay range for this role is $245,000 to $280,000 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.
J-18808-Ljbffr
Salary : $245,000 - $280,000
