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The Clinical Operations Asset Lead represents all Clinical Operations functions at the asset level and at the Medicines Development Team and other asset team interactions 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

Your responsibilities will include the following:

The Clinical Operations Asset Lead is typically assigned prior to commit to candidate and present throughout the lifecycle of an asset

• Contribution to the development of the Clinical Development Plan (CDP) and Integrated Evidence Plan (IEP), during Research, Development and Life Cycle Managment phases of the asset lifecycle.

  • Provides input into the overarching CDP and the development of studies that align to the CDP / IEP 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.

  • Utilizes lessons learnt and prior experiences to ensure best practises 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.

• Resourcing strategy

  • Leads resourcing discussions and accountable for the final strategy (in vs outsourcing) for the asset, and studies, in accordance with the resourcing strategy & principles.

  • Approves/endorses assessment, selection, contracting and management of appropriate vendors for outsourced clinical activities and services, ensuring compliance with GSK standards.

• Oversight of delivery quality

  • 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 Global Clinical Development 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 CRO provider.

• Delivery plan

  • 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. 

  • Drives innovative approaches to study execution through external facing advances in technology and sciences, by identifying and embracing risks and opportunity

  • Accountability 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

  • Accountability 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

  • To ensure clinical operational delivery with a collaborative partner in a co-development environment

  • Part of the clinical file submission team coordinating deliveries linked to interventional clinical and Epi studies and responses to questions ra