Clinical Research, Director, Clinical Research, Study Operations
About The Position
The Director provides leadership, oversight, and direction to Associate Directors, Project Managers, and clinical research staff to ensure high-quality execution of clinical studies, audit readiness, and alignment with R&D timelines and corporate goals. This role partners cross-functionally with R&D, Program Management, Study Development, Quality & Compliance, Medical Affairs, Marketing, Managed Care, and external sites to accelerate study start-up, optimize enrollment, and maintain regulatory compliance. The Director oversees a portfolio of clinical studies, forecasts resource and portfolio needs based on a 1-3 year roadmap, and drives long-range planning, process innovation, and operational excellence. Key responsibilities include establishing standards for site start-up, ensuring compliance with GCP and quality frameworks, partnering on continuous improvement initiatives, supervising Associate Directors, and ensuring high-quality data delivery to support analyses, publications, regulatory submissions, and broader evidence needs.
Requirements
- Advanced degree, required.
- 8 years of successful experience in the healthcare or clinical research field with progressive leadership responsibilities.
- Proven track record of managing multi-study portfolios across multiple therapeutic areas or modalities.
- Expertise in GCP, regulatory requirements, quality systems, and FDA expectations.
- Strong organizational leadership, communication, and cross functional collaboration skills.
Responsibilities
- Provide leadership, oversight, and direction to Associate Directors, Project Managers, and clinical research staff
- Ensure high-quality execution of clinical studies and audit readiness
- Partner cross-functionally with R&D, Program Management, Study Development, Quality & Compliance, Medical Affairs, Marketing, Managed Care, and external sites
- Accelerate study start-up and optimize enrollment
- Maintain regulatory compliance
- Oversee a portfolio of clinical studies
- Forecast resource and portfolio needs based on a 1-3 year roadmap
- Drive long-range planning, process innovation, and operational excellence
- Establish standards for site start-up
- Ensure compliance with GCP and quality frameworks
- Partner on continuous improvement initiatives
- Supervise Associate Directors
- Ensure high-quality data delivery to support analyses, publications, regulatory submissions, and broader evidence needs
Benefits
- Excellent Annual Salary + 35% Bonus Potential
- 20 Accrued PTO Days Annually + 10 Paid Holidays
- 401K with 100% Company Match up to 6%
- 3 Health Care Plan Options + Company HSA Contribution
- Company Stock Grant Upon Hire
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
Number of Employees
251-500 employees
