GSK’s success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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 raised by Health Authorities on operational activities. Responsible to deliver applicable operational modules for the file.

• Asset level risk register, communication, and systems data

  • 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 the technical content of the Target Medicines Profile 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).

Basic Qualifications

• Bachelor’s degree or equivalent in Life Science, Scientific or equivalent

• 10 years plus experience in managing clinical research projects or equivalent. Has an excellent understanding of project development, quality requirements and associated processes.

• Excellent knowledge and 5 years plus experience in clinical development and matrix management is required.

Preferred Qualifications

• Master’s Degree/Advanced Degree in Life Science, Scientific, or equivalent

• Experience working independently with senior executives and the ability to quickly build personal credibility and assimilate business issues/need.

• Highly effective verbal, written, presentation communications skills. operational project decisions

• Demonstrated ability to build trust and strengthen collaborative relationships with matrixed team members across teams, sub-teams, and functions.

• Knowledge of established models for critical thinking, innovation, negotiation, and influencing skills

#LI-GSK*

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

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

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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