Biosampling Project Leader

As Biosampling Project Leader, you will own biosampling strategy for your assigned assets (molecules, vaccines or projects) and oversee delivery across all the clinical studies within them.

You will be the primary point of contact for biosampling and laboratory strategy, working through matrix partnerships with Development Operations, scientific and therapeutic area leaders, external laboratories and vendors.

You will work alongside Biosampling Project Managers, our study delivery experts, and stay involved at study level where it matters most, particularly at set up, so that studies are started right and aligned across the asset.

Responsibilities

• Define and own the biosample strategy for your assigned asset(s), aligned with therapeutic area goals and ICH/GCP standards.
• Partner with Biosampling Therapeutic Area Leaders, Development Operations and scientific leaders to turn 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 first point of escalation for study-level biosampling and laboratory issues, defining corrective actions where needed.
• Own risk management and inspection readiness for your asset(s), and act as HBS custodian for studies within them.
• Mentor Biosampling Project Managers and contribute to functional and cross-R&D improvement initiatives.

Basic Qualifications

• Bachelor’s degree in life sciences, pharmacy, biomedical sciences, or a related field.
• Experience in clinical trial biospecimen management, including diverse sample types, laboratory management and LIMS, with a strong understanding of study set up requirements.
• Experience in clinical biomarker, bioanalytical and/or in vitro diagnostic development programs, with the scientific understanding to turn requirements into practical sampling plans.
• Proven experience managing and overseeing third-party vendors, contracts and budgets, including invoice approvals.
• In-depth knowledge of the clinical development process, GxP and global regulatory requirements.
• Strong communication and interpersonal skills, with demonstrated success influencing and leading through matrix teams without direct authority.
• Self-motivated and proactive, able to work independently while collaborating across disciplines.

Preferred Qualifications

• Advanced degree (Doctoral or Master’s) or equivalent experience.
• Experience setting strategy across a portfolio of studies or an asset, rather than a single study.
• Knowledge of global regulatory requirements for human biological samples.
• Experience mentoring or coaching colleagues.