Contractor, Director, Clinical Operations

A Waltham-based biotech client is seeking a seasoned clinical operations leader on a contract basis. The Director of Clinical Operations will own program strategy through to execution, driving the advancement of innovative therapies. The role carries accountability for clinical trial planning and delivery, GCP/ICH/FDA compliance, timeline and budget oversight, quality metrics, and regulatory submission support.

The position involves leading and developing a Clinical Operations team, managing CRO and vendor relationships, and fostering a culture of operational excellence and continuous improvement across global programs. Candidates with oncology or rare disease backgrounds and experience with CTMS, eTMF, and EDC platforms are strongly preferred.

• Lead clinical program strategy and execution, aligning with corporate objectives and development milestones
• Provide leadership to the Clinical Operations team, including resource planning, prioritisation, and performance management
• Oversee planning and execution of clinical trials to ensure compliance with GCP, ICH, FDA, and global regulatory requirements
• Monitor study timelines, budgets, risks, and quality metrics to support successful delivery
• Support regulatory submissions through development and review of key clinical documents and deliverables
• Manage CROs, vendors, and external partners to ensure accountability, quality, and financial oversight

• Bachelor's or Master's degree in Health Sciences or a related field
• 12+ years of clinical research experience, including 10+ years in clinical trial management and operational leadership
• Strong understanding of GCP, ICH, FDA, and global regulatory requirements
• Proven experience leading cross-functional teams and managing CRO and vendor relationships
• Exceptional communication, leadership, and strategic problem-solving skills
• Preferred: oncology or rare disease experience, CTMS/eTMF/EDC proficiency, and global biotech exposure

Stratacuity is a scientific staffing and placement firm connecting life sciences organisations with experienced clinical and research professionals. The firm places contractors and permanent staff across biotech, pharma, and related sectors, with a focus on delivering proven talent for critical development programmes.