At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. We're uniting science, technology, and talent to get ahead of disease together. This role offers growth, meaningful impact, and alignment with GSK's mission.
Requirements
- Provide clinical leadership for study strategy and design (Phase IāIV), 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), Investigatorās 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/NoāGo 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 ināstream 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.
Benefits
- Health care and other insurance benefits (for employee and family)
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver/parental and medical leave
