Global Clinical Development Associate Director

3 weeks ago

Stevenage, Hertfordshire, United Kingdom GSK Full time
Job Description

GSK is seeking an experienced Clinical Operations Leader to join our Global Clinical Development team. As a key member of our team, you will be responsible for leading the design, execution, and reporting of clinical trials, as well as providing strategic leadership and guidance to project teams and matrix teams.

The ideal candidate will have a strong background in clinical development, with experience in leading global oncology studies and a proven track record of delivering projects to time, cost, and quality. You will be responsible for generating robust and accelerated delivery plans, and delivering these to target or stretch thresholds.

You will work closely with our Study Delivery Lead (Team) Director, and will be accountable for planning and leading the delivery of oncology studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study proposal.

The role may span oncology assets from early through to late phase of development and include delivery through one or more of in-house, outsourced and alliance delivery models. This role is highly visible within Global Clinical Operations and in the Clinical Matrix Teams.

Key Responsibilities
  • Accountable for the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc) and for overall study deliverables.
  • Drive assessment, selection, engagement, management, and oversight of appropriate vendors.
  • Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
  • Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.
  • Work with matrix partners, asset lead and/or manager to develop and manage study level budget within project allocation.
  • Preparation of materials for governance and / or financial review cycles and provide expert clinical operational input into protocol development.
  • Lead and conduct investigator meetings and other study related meetings and participate in governance meetings as necessary.
  • Identify and communicate resource gaps for assigned studies.
  • Lead risk management and quality efforts to ensure study compliance and continual inspection readiness.
  • Lead / contribute to ways of working and process improvement initiatives. Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
  • Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study and collaborate with Oncology aligned staff in global functions to deliver the Clinical Study Report.
  • Work with the Oncology patient councils to develop patient centric documents and address patient burden.
Why You?

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

  • Bachelor's degree in life sciences or related discipline.
  • Extensive clinical development experience that is equivalent to 6 years as a global study leader with proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment.
  • Proven operational experience leading global oncology clinical trials and knowledge of essential global regulatory guidelines and ICH/GCP.
  • Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget.
  • Proven leadership skills, influencing and negotiation skills.
  • Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change.

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

  • Oncology phase III global registrational study leadership experience.
  • Proven clinical development experience across all phases of development (I-IV).
  • Experience of innovative trial design (platform, basket, umbrella, adaptive designs) and decentralised trials (DCT) initiatives.
  • Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary and ability to manage conflict.
  • Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
  • Creative thinker able to modernise approach to clinical delivery, leverage external technology and networks to deliver value.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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