Clinical Operations Asset Lead, Senior Director

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

The Clinical Operations Asset Lead represents all Clinical Operations functions at the asset level and is accountable for developing the operational strategy and delivery plan to execute the scientific strategy for an asset and associated studies, working in partnership with clinical / biostats / clinical supplies and the functional subject matter experts to ensure informed asset decision-making from the operational, scientific and data perspectives.

Key Responsibilities :

• Contribute to the development of the Clinical Development Plan and Integrated Evidence Plan, during Research, Development phases of the asset lifecycle.
• Provide input into the overarching Clinical Development Plan and the development of studies that align to the Clinical Development Plan and are feasible to implement in the clinical and regulatory environment of participating regions, to provide quality data and ensure timely study delivery, coordinating expert inputs from clinical and non-clinical functions.
• Utilize lessons learnt and prior experiences to ensure best practices and strategies.
• Be part of the protocol development finalization and subsequent amendments including relevant review boards / committees to ensure operational feasibility and consistency within the asset.
• Lead resourcing discussions and be accountable for the final strategy (in vs outsourcing) for the asset, and studies, in accordance with the resourcing strategy & principles.
• Approve / endorse assessment, selection, contracting and management of appropriate vendors for outsourced clinical activities and services, ensuring compliance with GSK standards.
• Lead escalation point from study and asset level to raise and assist with issues on behalf of the team, including serious quality incidents and serious breaches of GCP.
• Responsible for the coordination and leadership of cross-functional team input into development plans, ensuring quality delivery of all studies included within the plans.
• Ensure clinical operations inspection readiness at all times and supports preparations in the event that any studies within the asset is subject to inspection.
• Ensure regular interaction with clinical operations functions involved in the asset such that they are aware of issues, risks and successes with study delivery as they occur.
• For outsourced programs coordinate oversight to ensure the quality delivery by provider.
• Model scenarios for optimal asset / study delivery linked to value drivers and drives decisions presented to governance boards to optimise delivery with transparent implications to time, quality, risks resources and budget.
• Accountable for the operational planning, feasibility and delivery of their assigned asset(s) and associated Development Plan(s), on time and on budget, from beginning to end whilst optimizing time and cost efficiency, including resource utilization.
• Drive innovative approaches to study execution through external facing advances in technology and sciences, by identifying and embracing risks and opportunity.
• Accountable for asset delivery strategy (e.g. country, diversity, patient engagement strategies etc) in collaboration with cross-functional stakeholders, with particular accountability for Clinical Operations contributions to governance boards
• Accountable for budget forecasts for future interventional clinical and Epi studies and Clinical Operations asset level costs, ensuring they are accurately represented and managed in financial tools.
• Ensure clinical operational delivery with a collaborative partner in a co-development environment.
• Contribute to the clinical file submission team by coordinating deliveries linked to interventional clinical and Epi studies and responses to questions raised by Health Authorities on operational activities. Deliver applicable operational modules for the file.
• Ensure asset level operational risk management plan is in-place and applies a smart-risk taking philosophy.
• Accountable for asset level mitigation plans are implemented to avoid and manage risk / quality issues.
• Accountable for translating technical content to ensure appropriate operational implementation at the study level.
• Manages internal and external stakeholders through appropriate engagement and communication.
• Accountable for all data related to delivery strategy (e.g. country footprint, resourcing strategy) is accurate and contemporaneous in GSK systems (including clinical trial tracking systems).

Capabilities :

Why You?

Basic Qualifications :

Preferred Qualifications :

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.

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