Global Clinical Development Associate Director

2 weeks ago

London, Greater London, United Kingdom GlaxoSmithKline Full time
Job Title: Global Clinical Development Associate Director

We are seeking a highly experienced and skilled Global Clinical Development Associate Director to join our team. This role will be responsible for leading the development and execution of clinical trials, working closely with cross-functional teams to ensure timely and successful delivery of projects.

Key Responsibilities:
  • Develop and execute clinical trial strategies, including study design, protocol development, and site selection.
  • Lead and manage cross-functional teams, including clinical operations, data management, and biostatistics.
  • Collaborate with external partners, including CROs and vendors, to ensure successful delivery of projects.
  • Ensure compliance with regulatory requirements, including ICH/GCP guidelines and GSK SOPs.
  • Develop and manage study budgets, including vendor management and financial planning.
  • Lead and conduct investigator meetings and other study-related meetings.
  • Identify and communicate resource gaps for assigned studies.
  • Lead risk management and quality efforts to ensure study compliance and continual inspection readiness.
Requirements:
  • Bachelor's degree in life sciences or related discipline.
  • Extensive clinical development experience, 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.
Preferred Qualifications:
  • 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.
Why GSK?

GSK is a global biopharma company with a special purpose - to unite science, technology, and talent to get ahead of disease together. 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).

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.

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