Director, Clinical Operations

Deciphera Pharmaceuticals•Waltham, MA

About The Position

The Director, Clinical Operations provides strategic and operational leadership across multiple clinical programs and studies, translating clinical development strategy into strong operational execution. The role ensures programs are delivered with quality and accountability across timelines, budgets, and external partnerships. Initially overseeing approximately two clinical programs, the Director leads and develops a small Clinical Operations team. This position is suited to an experienced Clinical Operations leader who has progressed beyond individual study management into broader program ownership while remaining 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, ensuring alignment 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 provide oversight of contractors and external resources.
Partner across Clinical Development, Regulatory, Data Management, Safety, and other functions to support effective clinical program execution.
Lead CRO and vendor relationships, ensuring strong performance, financial accountability, quality, and delivery against program expectations.
Communicate program status, risks, and recommendations effectively 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.