Director of Knowledge Solutions responsible for knowledge management strategy at Troutman Pepper Locke. Collaborating with teams to ensure effective knowledge sharing and firm competitiveness.
About the role
- Clinical Development Director leading oncology clinical development efforts at GSK. Overseeing studies from early phase to regulatory approval in a collaborative environment.
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 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
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