Clinical Operation Asset Lead

工作内容

Site Name: Belgium-Wavre, Belgium-Rixensart

Posted Date: Mar 28 2023

Type of contract: Permanent

Location: Wavre, or Rixensart (Belgium)

Grade: 5

Join our challenge to get ahead of disease together!

The Clinical Operations Asset Lead represents all Clinical Operations functions at the asset level and at Early Development Team (EDT) , Medicine Development Team (MDT)/Vaccine Development Team (VDT), Medicine ClinicalTeam (MCT) /Vaccine Clinical Team (VCT)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

Your responsibilities:

The Clinical Operations Lead (COAL) will be accountable for:

Contribution to the development of the Clinical Development Plan and Integrated Evidence Plan, during Research, Development and LCM phases of the asset lifecycle.

• Provides input into the overarching CDP and the development of studies that align to the Clinical development Plan (CDP) / IIntegrated Evidence Plan (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.
• Utilises lessons learnt and prior experiences to ensure best practises and strategies.
• Be part of the protocol finalisation and relevant review boards/committees to ensure operational feasibility and consistency within the asset.
  
  

Resourcing strategy

• Leads resourcing discussions accountable on final strategy (in vs outsourcing) for the asset, and studies, in accordance with the resourcing strategy & principles.
• Approves/endorses assessment, selection, 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 Delivery (GCD) 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 Full Study Outsourcing (FSO) 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 delivery 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 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 TMP/TVP/IEP to ensure appropriate 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).
  
  

Why you?

Basic Qualifications:

• 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 requirements 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, showing conflict management and negotiation skills
• Partnering skills with key role such as clinical science, biostatistics, and other experts 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
  
  

Required

Education:

• Area of Specialization General Science or Life/Health related Science Degree.
  
  

Previous Experience:

• > 8 years of significant experience in managing clinical research projects or equivalent.
• Excellent understanding of project development, quality requirements and associated processes.
• Knowledge / Experience in study and matrix management is required.
• A proven experience of stakeholder management is required
• Risk management experience is required
• Project management skills are required
• Need of a good managerial and business skills
• A robust scientific background coupled with overall knowledge of drug/vaccine development processes to execute the job.
• Excellent communication and negotiation skills.
• Strong project management skills is required.
• This is a job description to aide in the job posting but does not include all job evaluation details.
  
  

Why GSK?

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.

Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our R&D focus is to deliver a new generation of vaccines and medicines using the science of the immune system, human genetics and advanced technologies to get ahead of infectious diseases, HIV, cancer and immune-mediated and respiratory diseases. We do all this with a commitment to operate responsibly for all our stakeholders by prioritising Innovation, Performance and Trust.

Our bold ambitions for patients are reflected in new commitments to growth and a significant step-change in delivery over the next five years. This means more GSK vaccines and treatments, including innovative new products, will reach more people who need them more than ever before.

We have long believed that building trust is key to stronger performance, helping to create value for shareholders, impact for patients and society and a reason outstanding people choose to work for and with us. That’s why being a responsible business is an integral part of our strategy. Taking action on environmental, social and governance issues is a key driver in our strategy.

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 our ambition for GSK to be 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 people 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.

We want GSK to be a workplace where everyone can feel a sense of belonging and thrive. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

We’re also working hard to become more inclusive in the way we do business. We’re building demographic planning into our clinical trials, so they reflect the real-world population that’s affected by the disease we’re studying. We’re engaging with diverse-owned suppliers that meet our standards and share our values. We’re also inspiring the next generation of diverse scientists by investing in STEM education programmes to improve career opportunities for people in under-represented communities.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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