Director, Clinical Operations

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Provide strategic and operational leadership across a variety of clinical programs and studies.

• Transform clinical development strategy into practical operational execution.

• Ensure the successful delivery of programs with a focus on quality and accountability within set timelines, budgets, and external collaborations.

• Initially manage approximately two clinical programs.

• Lead and cultivate a small Clinical Operations team.

• Oversee the planning and execution of clinical trials, including timelines, budgets, quality assurance, resource allocation, operational risks, and key performance metrics.

• Supervise contractors and external resources.

• Collaborate with Clinical Development, Regulatory Affairs, Data Management, Safety, and other departments.

• Manage relationships with CROs and vendors, ensuring performance, financial accountability, quality standards, and timely delivery.

• Report program status, risks, and recommendations to senior and executive leadership.

• Contribute to the development of regulatory documentation, ensuring clinical deliverables meet submission requirements and align with global regulatory standards.

• Perform additional duties and responsibilities as assigned.

⛳️ Requirements

• Bachelor’s or Master’s degree in health science or a related discipline.

• Over 12 years of clinical research experience, including at least 10 years in clinical trial management and leadership within Clinical Operations.

• Proven track record of managing multiple clinical programs and overseeing several concurrent clinical trials.

• Extensive experience in leading complex clinical trials with accountability for timelines, budgets, quality, and operational outcomes.

• Strong experience in managing CROs and vendors, including performance oversight, financial accountability, risk management, and issue resolution.

• Demonstrated ability to lead and develop members of the Clinical Operations team.

• Excellent communication skills with senior and executive leadership, and the ability to work across various functions and global locations.

• Comprehensive knowledge of GCP, ICH, FDA, and international clinical development regulations.

• Experience supporting global clinical programs, including collaboration with teams and partners in Japan.

• Background in oncology or rare disease clinical development.

• Familiarity with eTMF, EDC, IWRS, and RBQM platforms.

• Strong expertise in clinical program and study budget management.

• Experience within a small-to-midsize biotechnology organization.

• Willingness to participate in occasional early-morning or evening meetings with global colleagues.

• Willingness to travel for program activities, internal meetings, and industry conferences.

🏝️ Benefits

• Competitive salary and annual bonus.

• Comprehensive benefits package including medical, dental, vision insurance, and a 401(k) retirement plan with company match.

• Generous parental leave and family planning benefits.

• Exceptional organizational culture and opportunities for personal and professional development.

• Long-term incentive plan.

• A full range of benefits and additional incentive compensation plans (if applicable).