Location
This position requires an on‑site office‑based presence 2 to 3 days a week in the US (Waltham, MA or Upper Providence, PA), UK (London or Stevenage), Switzerland (Zug), Poland (Warsaw) or Canada (Mississauga, ON).
Position Summary
You will lead clinical development activities that advance oncology programs from early studies through regulatory interactions. You will work closely with cross‑functional teams, external experts, and leadership to design studies, interpret data, and shape clinical strategy. We value clear judgment, collaborative leadership, and a focus on patient safety. This role offers growth, meaningful impact, and alignment with GSK’s mission of uniting science, technology and talent to get ahead of disease together.
Responsibilities
- 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 on time, within 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.
Basic Qualifications
- 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).
Preferred Qualifications
- Experience with immuno‑oncology or advanced oncology modalities and biomarkers.
- Experience with clinical pharmacology, translational medicine or evidence generation planning.
- Experience driving change, improving processes, and adopting new approaches to study delivery.
- Advanced clinical degree (MD, PhD, PharmD, RN) or equivalent senior clinical research experience.
- Experience with regulatory submissions, Scientific Advice/EoP2 interactions, and safety governance committees (IDMC/ISRC).
- Publication record and conference presentation experience.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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