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GSK

Develops medicines, vaccines, and consumer health

Biosampling Project Leader

Clinical Research OperationsPosted on Nov 13
Full-timeWarsaw, Poland

About the Job

Requirements

  • A bachelor's degree in life sciences, pharmacy, biomedical sciences, or a related field is required.
  • Experience in clinical trial biospecimen management, including diverse sample types, laboratory management and laboratory information management systems (LIMS), with a strong understanding of study set-up requirements is required.
  • Experience in clinical biomarker, bioanalytical and/or in vitro diagnostic development programs, with the scientific understanding to translate requirements into practical sampling plans is required.
  • Proven experience managing and overseeing third-party vendors, contracts and budgets, including invoice approvals, is required.
  • In-depth knowledge of the clinical development process, Good Clinical Practice (GCP), and global regulatory requirements is required.
  • Strong communication and interpersonal skills, with demonstrated success influencing and leading through matrix teams without direct authority, are required.
  • The candidate must be self-motivated and proactive, able to work independently while collaborating across disciplines.

Responsibilities

  • Define and own the biosample strategy for assigned assets, aligned with therapeutic area goals and International Council for Harmonisation/Good Clinical Practice (ICH/GCP) standards.
  • Partner with Biosampling Therapeutic Area Leaders, Development Operations and scientific leaders to translate asset-level needs into a clear sampling and laboratory approach.
  • Partner with Biosampling Project Managers on study set-up at central laboratories and third parties, ensuring alignment across the asset.
  • Provide program-level oversight of external laboratories and vendors, including selection, performance and biosampling cost management.
  • Act as the first point of escalation for study-level biosampling and laboratory issues, defining corrective actions where needed.
  • Own risk management and inspection readiness for assigned assets, and act as the HBS custodian for studies within them.
  • Mentor Biosampling Project Managers and contribute to functional and cross-R&D improvement initiatives.

Desired Qualifications

  • An advanced degree (doctoral or master's) or equivalent experience is preferred.
  • Experience setting strategy across a portfolio of studies or an asset, rather than a single study, is preferred.
  • Knowledge of global regulatory requirements for human biological samples is preferred.
  • Experience mentoring or coaching colleagues is preferred.

About the Company

GSK

Develops medicines, vaccines, and consumer health

GSK is a global healthcare company focused on three main areas: Pharmaceuticals, Vaccines, and Consumer Healthcare. It develops medicines, vaccines, and consumer health products to improve health outcomes worldwide. Its products address diseases in respiratory, HIV, oncology, and immuno-inflammatory areas; vaccines for influenza, shingles, and COVID-19; and over-the-counter wellness products. The company relies on substantial R&D and strategic partnerships to bring new products to market and to address health needs. Revenues come from sales of medicines, vaccines, and consumer health items, often complemented by patient support programs and collaborations with governments and biotech partners.

Company size
10,001+
Company stage
IPO
Headquarters
London, United Kingdom
Founded
1891

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