Global Study Director

Role Summary

Global Study Director, Cell Therapy in Clinical Operations leads delivery of cell therapy development programs, applying oncology expertise to advance cancer medicines from concept to final study reports and closure.

Responsibilities

• Clinical Operations delivery of a single or several smaller development programs or leading multiple studies or single sophisticated/novel studies.
• Provide authoritative input to project or study level documents (e.g., clinical development plan, clinical study protocol, clinical study report) and may own the delivery of study documents.
• Lead and deliver operational options for review at Investment Decision Governance interactions.
• Own the delivery of the clinical study(s) or program(s) from concept to final CSR and through study closure and archiving within agreed budget, time, and quality standards.
• Maintain oversight of study/program deliverables and sponsor oversight throughout the study life cycle.
• Develop and lead risk management/mitigation plans to ensure timely, quality, and cost-effective delivery; escalate issues as appropriate.
• Plan and lead issue resolution and customer concerns; provide forecast/input on study/program delivery costs, resources, and timelines.
• Ensure quality of planning information in relevant systems; mentor and develop others; interact with external entities (regulatory, partners, collaborators); oversee CROs and other vendors.
• Oversee study-level reporting of progress, risks, and issues; lead delivery-related activities for regulatory inspections/audits with Clinical Quality Assurance; provide outsourcing procurement specifications; review contracts/work orders.

Qualifications

• Required: Bachelor’s degree in a related subject (medical/biological science); 10+ years of drug development experience in pharma or biotech.
• Required: Clinical Operations and Cell Therapy or Gene Therapy experience; strong track record delivering to timelines, cost, and quality; experience leading across internal and external organizations; excellent ICH-GCP knowledge; matrix leadership; strong communication and conflict resolution skills; problem solving; ability to lead strategic/operational management of clinical trials; experience in providing external contract requirements and vendor management.
• Desirable: Advanced degree (PhD, MSc, MPhil); program management qualification (MBA, PRINCE2, PMP); experience across academic/CRO/sponsor contexts and early-phase clinical delivery.

Skills

• Clinical Operations leadership for cell therapy or gene therapy programs.
• Operational delivery excellence in timelines, cost, and quality.
• Stakeholder management across internal/external teams; collaboration in matrix environments.
• Regulatory and quality awareness; risk management; issue resolution; outsourcing and contract management.

Education

• Bachelor’s degree in medical or biological sciences (required).
• Advanced degree and program management qualifications (preferred).