Senior Director/Executive Director Clinical Operations
New
United StatesFull-TimeDirector
Salary240,000 - 275,000 USD per year
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Job Details
- Experience
- Minimum of 10 years for senior director and minimum of 20 years for executive director with progressive advancement within clinical operations in the pharmaceutical/biotech industry.
- Required Skills
- Budget management
Requirements
- B.A/B.S required; M.S., PhD, PharmD, MD or other related advanced scientific degree strongly preferred.
- Minimum of 10 years (Senior Director) or 20 years (Executive Director) of progressive advancement in clinical operations within the pharmaceutical/biotech industry.
- Extensive experience with clinical trial management, study feasibility, and budget/financial planning.
- Proven expertise in managing relationships with CROs and investigative sites.
- Strong knowledge of FDA regulations and ICH GCP guidelines.
- Demonstrated ability to develop and implement clinical operational strategic plans.
- Strong leadership skills with experience building and training teams in a matrix environment.
- Ability to collaborate effectively with physicians, scientists, and cross-functional stakeholders.
- Strong communication, persuasion, and decision-making skills to influence strategic direction.
- Entrepreneurial mindset and ability to work in a consensus-driven, dynamic environment.
Responsibilities
- Direct, supervise and manage all aspects of clinical trials to ensure that corporate and department goals/objectives for clinical development programs are met on time and within budget.
- Interact with multidisciplinary teams in a matrix environment, developing resourcing, budgeting, financial and strategic planning for clinical programs/studies.
- Create and execute clinical operational strategic plans in line with product strategy and resource allocation.
- Manage strategy and clinical operation sections of regulatory documents including data summarization, protocols, Investigator Brochures, and IND annual reports.
- Prepare and present clinical development trial updates to senior management, review potential issues, and propose mitigations.
- Develop study feasibility, cost estimates, input into contracts, and analyze tools/processes to support outsourcing.
- Build, develop and train internal staff and external vendors, and structure the department for efficiency.
- Develop and ensure compliance with SOPs and guidelines, FDA regulations, and current ICH GCP guidelines.
- Oversee and maintain relationships with Contract Research Organizations and investigative sites.
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