Director Non-Interventional Studies (NIS) Planning & Delivery FSP Partnerships

GSK; Ruislip; On-site; GBP 60,000 - 80,000; Full time

Job summary

A global biopharma company in the United Kingdom is looking for an experienced leader to manage Non-Interventional Studies (NIS) planning and delivery. The role includes oversight of project delivery, budget management, and compliance with guidelines. Essential qualifications include a Bachelor’s degree in a relevant field and extensive experience in clinical operations management. The ideal candidate will excel in stakeholder engagement and drive strategic improvements in study delivery.

Benefits

Agile working culture

Equal Opportunity Employer

Flexibility options for roles

Qualifications

• Extensive experience in managing clinical operations with strong knowledge of Non-Interventional Studies.
• In-depth knowledge of study management and clinical development process.
• Experience managing resources from internal and external sources.

Responsibilities

• Lead operationalization of the NIS P&D Study Delivery FSP model.
• Oversee compliance with contracts and financial controls.
• Monitor KPIs and elevate issues through governance structures.

Skills

Clinical operations management

Non-Interventional Studies expertise

People management

Regulatory knowledge

Education

Bachelor’s degree in General Science or Life/Health related Science Degree

Job description

Company Overview

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. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. GSK has kicked off 2025 with impressive growth in sales, profits, and earnings. We anticipate five major new FDA product approvals and 15 phase III/pivotal study readouts over the next two years. So far, we have secured two FDA approvals, with three more expected later this year. By uniting science, technology, and talent, we are committed to getting ahead of disease together.

Job Purpose

GSK is seeking an experienced leader to support the Non‑Interventional Studies Planning & Delivery Study Delivery Leadership Team on implementing and executing the oversight on Study Delivery FSP resourcing strategies with third parties within the NIS P&D organisation. This role is fully accountable for managing the overall delivery, cost and quality of projects and contracts assigned to meet organisational expectations, to enable efficient and cost‑effective delivery of NIS P&D Study Delivery FSP resourcing model for the NIS P&D organisation. Management of the budget to meet the relevant budget targets and ensure it is in line with the wider clinical operations targets.

Key Responsibilities

• Lead and manage the operationalization of the NIS P&D Study Delivery FSP model, ensuring strategic oversight, governance, and continuous improvement in collaboration with internal and external stakeholders.
• Oversee design, implementation, and transition to the FSP operating model.
• Build and maintain strong partnerships with FSP vendors for seamless program delivery.
• Drive process improvements and strategic enhancements to FSP models.
• Ensure compliance with governance frameworks, contracts, and financial controls.
• Liaise with Procurement, HR, Legal, Finance, and CRO managers to align with business expectations.
• Monitor KPIs, risks, and cost‑saving measures; elevate issues through governance structures.
• Act as primary liaison for issue resolution across processes, countries, and study‑level concerns.
• Provide operational guidance on systems onboarding, training, and WoWs.
• Implement initiatives to improve study delivery performance and team capability.
• Serve as business owner for all FSP services, including budget oversight and legal documentation.

Basic Qualifications

• Bachelor’s degree or equivalent in General Science or Life/Health related Science Degree.
• Extensive experience in managing clinical operations with strong knowledge and experience of Non‑Interventional Studies (NIS).
• In‑depth knowledge of study management, essential regulatory guidelines worldwide, and the clinical development process.
• Experience in People Management and management of resources from different sources in different locations (internal, external, functional service providers).
• Experience in management of Third Parties.

Preferred Qualifications

• Advanced degree in General Science or Life/Health related Science Degree.
• Excellent knowledge and understanding of clinical operations and activities associated to study delivery.
• Excellent knowledge of ICH‑GCP and Regulations.
• Knowledge of Industry and CRO world. Experience working with functional service providers.
• Excellent customer orientation, ability to work beyond silos with a strong service provider mindset.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [e-mail] or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive.

For more information about transparency requirements, visit https://openpaymentsdata.cms.gov/.