Director Non-Interventional Studies (NIS) Planning & Delivery

GSK; Stevenage; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading pharmaceutical company in the United Kingdom is seeking an experienced leader to manage the Non-Interventional Studies Planning & Delivery team. This full-time role includes overseeing the FSP model's operationalization and enhancing study delivery performance. Candidates should have extensive experience in clinical operations and possess a relevant degree, alongside strong people management skills. The company emphasizes compliance and strong partnerships, offering a dynamic work environment focused on patient impact.

Qualifications

• 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.

Responsibilities

• Lead and manage the operationalization of the NIS P&D Study Delivery FSP model.
• Oversee design implementation and transition to the FSP operating model.
• Build and maintain strong partnerships with FSP vendors.
• Drive process improvements and strategic enhancements to FSP models.

Skills

Bidding

Customer Service

B2C

Account Management

Fire And Safety Engineering

Education

Bachelors degree in General Science or Life/Health related Science Degree

Advanced 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 foster 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

• Bachelors 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 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

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, 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.

Key Skills

• Bidding
• Customer Service
• B2C
• Account Management
• Bus Driving
• Fire And Safety Engineering

Employment Type: Full‑Time
Experience: years
Vacancy: 1

Create a job alert for this search