Director, Clinical Operations
About The Position
The Director, Clinical Operations provides strategic and operational leadership across multiple clinical programs and studies, translating clinical development strategy into effective operational execution. The role ensures programs are delivered with quality and accountability across timelines, budgets, and external partnerships. Initially, the Director will oversee approximately two clinical programs and lead and develop a small Clinical Operations team. The position calls for an experienced leader with broad program ownership who is also comfortable with hands-on execution in a fast-paced biotech environment. The role involves regular collaboration with global colleagues, including teams in Japan, which may occasionally require early-morning or evening meetings. Some travel is required for program activities, internal meetings, and industry conferences.
Requirements
- Bachelor’s or Master’s degree in health science or a related field.
- 12+ years of clinical research experience, including at least 10 years in clinical trial management and Clinical Operations leadership.
- Demonstrated ownership of multiple clinical programs and experience overseeing several clinical trials concurrently.
- Significant experience leading complex clinical trials with accountability for timelines, budgets, quality, and operational delivery.
- Strong CRO and vendor management experience, including performance oversight, financial accountability, risk management, and issue escalation.
- Demonstrated experience leading and developing Clinical Operations team members.
- Ability to communicate effectively with senior and executive leadership and work across functions and geographies.
- Strong knowledge of GCP, ICH, FDA, and global clinical development requirements.
Nice To Haves
- Experience supporting global clinical programs, including collaboration with teams and partners in Japan.
- Oncology or rare disease clinical development experience.
- Experience with eTMF, EDC, IWRS, and RBQM platforms.
- Strong clinical program and study budget management experience.
- Experience working within a small-to-midsize biotechnology organization.
Responsibilities
- Provide Clinical Operations leadership across multiple programs and studies, aligning execution with broader development objectives.
- Oversee clinical trial planning and execution, including timelines, budgets, quality, resourcing, operational risks, and key metrics.
- Lead and develop Clinical Operations team members and oversee contractors and external resources.
- Partner with Clinical Development, Regulatory, Data Management, Safety, and other functions to support clinical program execution.
- Lead CRO and vendor relationships, ensuring performance, financial accountability, quality, and delivery against program expectations.
- Communicate program status, risks, and recommendations to senior and executive leadership.
- Contribute to regulatory documentation and ensure clinical deliverables support submission requirements and global regulatory expectations.
- Perform other duties and responsibilities as assigned.
Benefits
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical, dental, and vision insurance, and a 401(k) retirement plan with company match.
- Generous parental leave and family planning benefits.
- Opportunities for personal and professional growth.
- Long-term incentive plan and other incentive compensation plans, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Director
