NIS P&D Study Delivery Lead, Associate Director

GSK

16d • Hybrid

About The Position

The primary responsibility of the Non-Interventional Study (NIS) Planning and Delivery (P&D) Study Delivery Lead (SDL), Associate Director, is to lead the full lifecycle of clinical studies and trials within the NIS portfolio. This includes designing, executing, and reporting interventional studies, complex regulatory commitment studies (such as PASS and registries), and large multicentre, multi-country primary data studies. Additionally, this role may involve leading and managing team members within the NIS P&D Team. The position requires a performance-driven, seasoned study management professional with a strong sense of urgency, exceptional organisational credibility, and deep understanding of the NIS scientific and operational aspects of the pharmaceutical R&D business.

Requirements

• Bachelor’s degree in life sciences or related discipline.
• Proven experience in clinical operations or related research.
• In-depth knowledge of end-to-end study management, essential regulatory guidelines worldwide, and the clinical development process.
• Excellent leadership, influencing and negotiation skills. Ability to work independently and proactively and to take on leadership roles on cross-functional teams.
• Ability to build strong relationships and collaborate successfully, managing trusted stakeholder relationships internally and externally at all levels in a highly dynamic and matrixed environment.
• Experience managing vendors.

Nice To Haves

• Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience.
• Knowledge and experience of Non-Interventional Studies (NIS).
• 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.
• Demonstrated experience leading in both matrix and line environment to deliver projects, develop clinical plans, and manage change.
• Proven experience in managing relationships with vendors to ensure successful delivery of projects.

Responsibilities

• Planning and leading the delivery of assigned studies to timelines, quality, budget, company standards and scientific requirements; from concept to final study report and archiving. Including the assessment, selection, engagement, and management of appropriate vendors. Act as the primary contact for vendor at study level.
• Ensures compliance with ICH/GCP & ENCePP guidelines and/or applicable guidelines for NIS such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
• Proactively generating ideas for above-study improvements and implementing new business processes and strategies. Driving innovative approaches to study delivery through external facing advances in technology and sciences.
• Supporting the technical and leadership development of NIS Planning & Delivery staff through mentoring and coaching and may also be responsible for line managing NIS P&D Study Delivery Leads and/or industrial placement students.

Benefits

• We create a place where people can grow, be their best, be safe, and feel welcome, valued and included.
• We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
• We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees