Clinical Development Director, Oncology

Role Overview

• Lead clinical development activities that advance oncology programs from early studies through regulatory interactions.
• Work closely with cross-functional teams, external experts, and leadership to design studies, interpret data, and shape clinical strategy.
• Provide clinical leadership for study strategy and design (Phase I–IV), ensuring consistency with the CDP, asset profile and regulatory expectations (MHRA, HRA, EMA and other relevant authorities).
• Lead protocol development from concept to final study report, authoring/reviewing the Clinical Study Proposal (CSP), Investigator’s Brochure (IB) and clinical sections of regulatory submissions.
• Ensure study objectives, endpoints and safety monitoring meet regulatory, ethical and medical governance standards; establish and monitor Go/No‑Go criteria.
• Integrate internal and external scientific evidence (literature, conferences, competitor data) to shape strategy and interpret findings.
• Lead clinical matrix teams and collaborate with Clinical Operations, Biostatistics, Clinical Pharmacology, Safety/Pharmacovigilance, Regulatory Affairs and other stakeholders to deliver studies to time, quality and budget.
• Provide clinical input to regulatory interactions and submissions (e.g., IND/CTA, Scientific Advice, EoP2, MAA/NDA/BLA); prepare briefing materials and support regulatory meetings.
• Oversee clinical safety reporting, support DSURs and expedited reporting, and coordinate responses to Ethics Committees/IRBs and IDMCs.
• Drive clinical interpretation for CSRs, publications, abstracts and external presentations; represent programs externally where required.
• Contribute to process improvements that enhance study quality, efficiency and data integrity.
• Define clinical elements of protocols and present at governance forums (e.g., Protocol Review Forum).
• Ensure protocol and study documentation reflect input from internal and external experts and uphold patient safety.
• Participate in eCRF design/UAT and advise on analysis and reporting plans.
• Lead in‑stream data reviews, interim analyses and IDMC interactions as needed.
• Provide clinical leadership at Investigator Meetings and for site communications.
• Support publication strategy and external scientific engagement activities.

Requirements

• Master's Degree in a life science, medicine or equivalent with relevant clinical research experience.
• Demonstrable oncology or immuno‑oncology clinical development experience across early and late phases.
• Proven matrix leadership and ability to influence cross‑functional stakeholders.
• Knowledge of UK/EU regulatory frameworks (MHRA, HRA, EMA) and international submission processes.
• Strong clinical judgement, data interpretation skills and effective communication across governance and external audiences.
• Minimum 2 years clinical scientist experience (oncology preferred)

Tech Stack

• Go

Benefits

• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Paid caregiver/parental and medical leave