Role Summary
The NIS P&D TA Study Delivery Head leads a team of Study Delivery Leads (SDLs) in executing Non-Interventional Studies (NIS) within their designated therapy area (TA) across multiple sites. These studies are aligned with the integrated evidence plans across both the Research & Development (R&D) and marketed product portfolios. The role involves close collaboration with functional leaders in the NIS portfolio, such as the Global Real-World Evidence & Health Outcomes (gRWE&HO) TA Head, the Epidemiology TA Head, and the NIS P&D TA Project Management Head, to ensure the successful delivery of study outcomes (including timelines, quality, and budget). The NIS P&D TA Study Delivery Head is accountable for the operational execution of the TA portfolio, working within the established operational support model. This position is part of the NIS P&D Leadership Team. Locations include USA - Pennsylvania - Upper Providence, Belgium-Wavre, Canada - Ontario - Mississauga, GSK HQ, UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham, Warsaw.
Responsibilities
- Lead and develop a team of Study Delivery Leads, accountable for optimal study delivery support models.
- Partner with TA and functional stakeholders to optimize NIS study timelines and scenarios, enabling delivery of Global Epidemiology, Data Generation, and Clinical Development Plans.
- Collaborate with TA-aligned functions, building strong relationships and influencing across Global Clinical Operations.
- Contribute to asset and study governance and protocol development to ensure operational feasibility, consistency, quality, cost efficiency, and timely delivery.
- Plan, prioritize, and allocate TA resources in line with business priorities; oversee hiring, performance management, coaching, and development.
- Ensure compliance with ICH/GCP, ENCePP, GVP, GEP, CIOMS, applicable regulations, and GSK SOPs.
- Drive innovation in study delivery through advances in technology and science.
- Support early feasibility and engagement activities prior to SDL assignment.
- Lead or contribute to global, cross-functional business improvement initiatives across R&D and CPO.
- Implement new business processes and strategies.
- Manage and oversee FSO/FSP vendor relationships, acting as escalation point and driving continuous improvement.
Qualifications
- Required: Bachelorโs degree in life sciences or related discipline.
- Required: Ten years minimum experience in clinical operations or related research.
- Required: Five or more years of expertise and experience in Non-Interventional Studies (NIS) with a strong background in the Oncology Therapy Area.
- Required: Five or more years of experience leading a team.
- Preferred: Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience.
- Preferred: Proven experience in managing vendor relationships to ensure effective resourcing strategies and successful project delivery.
- Preferred: Proven ability to define the best decision for the organization and not one function.
- Preferred: Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
- Preferred: Demonstrated experience leading in both matrix and line environment to deliver projects, develop clinical plans, and manage change.
Skills
- Leadership and team development
- Strategic planning and resource management
- Strong stakeholder management and cross-functional collaboration
- Project management and cross-functional delivery within R&D and Clinical Operations
- Familiarity with ICH/GCP, ENCePP, GVP, GEP, CIOMS, and regulatory requirements
- Vendor management and subcontractor oversight
- Problem identification and proactive issue resolution
Education
- Bachelorโs degree in life sciences or related discipline
- Preferred: Advanced degree (MS, PhD, PharmD) or equivalent experience