Director, Clinical Operations

Deciphera Pharmaceuticals • Waltham, MA

4d • $190,000 - $261,000 • Onsite

About The Position

The Director, Clinical Operations is responsible for ensuring that clinical stage programs achieve strategic and operational objectives within established timelines, budget, and quality standards. This role provides leadership to the Clinical Operations team, contributes to the development of clinical program strategies, and ensures superior execution, collaboration, and transparency across functions. The Director partners with internal stakeholders and external partners to drive high-quality clinical trial delivery in a fast-paced, small-to-midsize biotech environment.

Requirements

• Bachelor’s or Master’s degree in health science or related field required.
• Minimum of 12 years of clinical research experience, with at least 10 years in clinical trial management and operational leadership roles.
• Comprehensive understanding of clinical development processes, GCP, ICH, and global regulatory requirements.
• Proven ability to lead cross-functional teams and manage external CROs and vendors effectively.
• Exceptional leadership, communication, and organizational skills.
• Strong strategic thinking and problem-solving abilities with a focus on operational excellence.

Nice To Haves

• Experience in oncology or rare disease clinical programs preferred.
• Demonstrated success managing global programs in a small-to-midsize biotech environment.
• Experience with clinical systems such as eTMF, CTMS, and EDC platforms.
• Proficiency in budget management and vendor performance tracking.
• Ability to lead in a dynamic, collaborative, and evolving organization.

Responsibilities

• Develop and execute clinical program strategies that align with corporate goals.
• Provide leadership to the Clinical Operations team and ensure efficient resource allocation across programs.
• Ensure clinical trials are properly defined, planned, and executed according to GCP, ICH, and FDA standards.
• Oversee study timelines, budgets, and quality metrics to achieve operational excellence.
• Assist in authoring key regulatory documents and ensure that clinical program deliverables align with submission requirements and regulatory expectations.
• Manage and oversee CROs, vendors, and external partners to ensure performance, deliverables, and financial accountability meet expectations.
• Foster a collaborative culture within Clinical Operations and serve as a leadership role model.
• Promote transparent communication, accountability, and operational discipline across the department.
• Other duties and responsibilities as assigned.

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 251-500 employees