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Clinical Development Director, Clinical Operations Asset Lead

3 months ago

Brentford, Greater London, United Kingdom GlaxoSmithKline Full time

Site Name: USA - Pennsylvania - Upper Providence, Canada - Ontario - Mississauga, GSK House, UK - Hertfordshire - Stevenage

Posted Date: Mar

GSK site preferred locations: Upper Providence - Collegeville, PA, Mississauga, Canada, Stevenage, UK, GSK House.

New GSK UK Headquarters - move from GSK House, Brentford

We're moving towards a more sustainable future with our new headquarters. With better public transport links and proximity to world-class science and technology institutions, we're excited for our move to the vicinity of Earnshaw Street, London WC1A ("the New HQ") by end H1 2024.

Closing Date for Applications: April 12th, 2023 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

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

This role will provide you the opportunity to:

  • Contribution to the development of the Clinical Development Plan and Integrated Evidence Plan, during Research, Development phases of the asset lifecycle.
  • Provides 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.
  • Utilises lessons learnt and prior experiences to ensure best practises and strategies.
  • Be part of the protocol development finalisation 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 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.
  • 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 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:

  • Demonstrates conceptual, analytical and strategic thinking to innovative approaches to clinical delivery, leverage external technology and networks and build internal capability
  • Ability to translate strategic concepts, scientific requirements, stakeholder feedback and expectations into cohesive actions for the Asset team
  • Ability to define value-driven vision and roadmap for the Clinical and or Epi Development Plan
  • Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment, demonstrating conflict management and negotiation skills
  • Partnering skills with key role such as clinical science, biostatistics and other subject matter experts (SME) at asset level to articulate and champion key decisions and strategy
  • Excellent leadership skills building and managing matrixed teams, promoting motivation and empowerment of others to accomplish individual, team and organizational objectives
  • Excellent influencing and stakeholder management skills at all levels of the organization.
  • Highly developed communication skills appropriate to the target audience, promoting effective decision-making
  • Ability to effectively prioritize activities and stakeholder needs whilst balancing the broader business needs with the needs of their specific asset
  • Competent in working with complexity and uncertainty within the external regulatory environment (e.g. FDA, EMEA)
  • Innovative and change adept whilst identifying and embracing risks as opportunities
  • To be an external advocate, representing GSK at congresses, industry bodies or other external opportunities
  • Ability to represent the function in change initiatives or SME roles, embracing and promoting GSKs' values and culture

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Bachelor's in general science or Life/Health related Science Degree required.
  • 12 years of significant experience in managing clinical research projects.
  • Leadership experience with senior stakeholder management.
  • Experience in study and matrix management is required.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Master's degree in the following preferred: Pharmacy, Chemistry, Bio Engineer, Biology, Biomedical Sciences, Project Management, Business School
  • Has an excellent understanding of project development, quality requirements and associated processes.

Why GSK?

We're combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

Find out more:

Our approach to R&D.

#LI-GSK

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