Director of Clinical Operations

Location: Oxford (Hybrid/1-2 days on site per week)

Full-time | Permanent

About the Role

An exciting opportunity has arisen for an experienced Director of Clinical Operations to lead and shape global clinical trials within a pioneering oncology development environment. Reporting to the Vice President of R&D Operations, this senior role is integral to the strategic and operational delivery of clinical programs in oncology.

You’ll join a dynamic, cross-functional team where science meets strategy—taking ownership of clinical operations across all phases of development, from feasibility through to regulatory submission. This is an excellent opportunity for a senior clinical leader to make a tangible impact in a rapidly evolving field.

Key Responsibilities

• Lead the end-to-end operational delivery of global clinical studies, ensuring compliance with ICH-GCP and relevant regulatory standards.
• Provide leadership and oversight across all clinical operations activities—delivering projects on time, within scope and budget.
• Line manage and mentor the Clinical Operations team, fostering a culture of excellence, accountability, and continuous improvement.
• Oversee vendor and CRO selection, contract negotiation, performance management, and issue resolution across outsourced clinical trials.
• Serve as the primary escalation point for study-related risks and challenges, developing and implementing mitigation strategies.
• Collaborate with internal functions (e.g., Medical, Imaging, Quality, Regulatory, Biometrics, CMC) to drive cross-functional alignment.
• Participate in study and protocol design, including cost and timeline estimation, feasibility, and risk assessments.
• Own the clinical operations budget, including SAP financial management, purchase order tracking, and forecasting.
• Ensure audit readiness and lead the hosting of GCP audits and regulatory inspections, in collaboration with Quality Assurance.
• Lead the implementation and management of Trial Master File (TMF) systems, ensuring documentation quality and data integrity.
• Contribute clinical operations expertise to new business cases and portfolio planning activities.
• Stay abreast of industry trends, champion innovation, and contribute to best practices both internally and externally.

Your Background & Experience

• Graduate degree (or equivalent) in life sciences, medical sciences, or a discipline associated with clinical research.
• 10+ years of experience in clinical operations or clinical project management within pharma, biotech, or CRO environments.
• Proven expertise in global oncology clinical trials, ideally spanning both early and late-stage development.
• Strong operational understanding of the drug development lifecycle, protocol development, trial execution, and data analysis.
• Familiarity with radiopharmaceuticals and/or imaging modalities is highly desirable.
• In-depth knowledge of EMA, FDA, ICH, and GCP regulatory frameworks.
• Demonstrated experience in vendor/CRO oversight, budgeting, and contract negotiation.
• Excellent leadership and communication skills, with a track record of developing high-performing teams.
• Comfortable working across functional teams and influencing at all levels of an organization.
• Skilled in change management, process improvement, and operational excellence.

What’s Offered

• Opportunity to play a key leadership role in the development of cutting-edge diagnostic therapies in oncology.
• Work in a collaborative, science-driven environment with global impact.
• Competitive salary and benefits package.
• Hybrid/flexible working arrangements.

Tshering Sherpa

Tsherpa@planet-pharma.co.uk