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)

Benefits

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical developmentstudy designprotocol developmentdata interpretationclinical safety reportingeCRF designinterim analysesclinical study proposalinvestigator's brochureregulatory submissions

Soft Skills

leadershipinfluencecommunicationclinical judgementcollaborationprocess improvementstakeholder engagementcross-functional teamworkpresentation skillsdata integrity

Certifications

Master's Degree in life scienceMaster's Degree in medicine