Responsibilities:
- Drive implementation of clinical diagnostic plans for oncology programs (early/late stage), ensuring audit readiness.
- Develop diagnostics biosample collection, processing, and storage strategies (feasibility and cost effectiveness).
- Plan and implement biosample collection: define materials, create/review lab manual, oversee kit development, set up databases, etc.
- Forecast and plan biosample analysis and sample management costs.
- Contribute to protocols and ICFs to ensure sample testing aligns with the diagnostic plan.
- Partner with Clinical Operations to draft site communications/training; train CROs/internal teams on sample collection/processing.
- Project manage assay implementation at reference labs and centralized testing vendors; ensure assay/data delivery; serve as key contact for assay lab.
- Align outputs with Data Management/Biostatistics needs; provide input into data transfer agreements.
- Serve as first point of contact for diagnostic biosample operational issues; coordinate with internal/external partners (e.g., laboratory study management, clinical ops, diagnostic leads, CROs).
- Provide regular study-level status updates and tracking reports for select samples.
- Identify/document/manage project risks; lead or contribute to process/system improvements; own assigned governance/training/task area.
- Coach/mentor as subject matter expert and model GSK values.
Basic Qualifications:
- Bachelorβs degree in biological sciences (or related).
- 4+ years industry experience.
- Clinical trial specimen management experience.
- Oversight of third-party vendors/labs including contracting.
- Oncology therapeutic area experience.
- Diagnostic assay development and validation experience.
Preferred Experience:
- Masterβs/Doctoral (or equivalent).
- Matrix/line management experience.
- Diverse sample types, LIMS, and project management experience.
- Strong communication/interpersonal/matrix skills.
- Knowledge of global diagnostic regulatory requirements (including sample exportation).
Compensation/Benefits (US locations): Base salary range $151,500β$252,500 plus annual bonus and eligibility for long-term incentive; health/insurance, retirement, paid holidays/vacation, and paid caregiver/parental and medical leave.
How to Apply:
- Submit application with a short note on what excites you and how your experience matches the role.