Senior Vendor Laboratory Manager Clinical Laboratory & Biospecimen Management
BioMarin Pharmaceutical Inc.
August 12, 2026
Remote friendly (United States)
United States
$98,000 - $130,000 USD yearly
Operations
SUMMARY DESCRIPTION:
Senior Vendor Laboratory Manager (SVLM) within CLBM responsible for program-level laboratory and biospecimen management oversight. Serves as subject matter expert, strategic partner, mentor, and matrix leader to ensure compliant, efficient, high-quality delivery.
KEY RESPONSIBILITIES:
- Lead CLBM delivery across complex/multiple studies/programs; ensure alignment with protocol requirements, timelines, intended use, and decision needs.
- Oversee study start-up, maintenance, close-out, and vendor transition; meet clinical timelines/deliverables.
- Identify cross-study dependencies/risks/process gaps and drive resolution via action plans and stakeholder alignment.
- Provide senior-level oversight of CLBM deliverables, risks, and milestones.
- Lead/sponsor complex vendor relationships and escalations; contribute to sourcing, selection, scope development, contracting, pricing assumptions, and performance oversight.
- Evaluate vendor capabilities/operating models/technologies/assay feasibility.
- Act as SME for assay intended use, biomarker implementation, biospecimen governance, and regulatory expectations.
- Triage/respond to health authority/regulatory questions; consult on residual biospecimen integrity, future use, and disposition.
- Lead resolution of complex quality/compliance/biospecimen/data delivery issues; execute risk mitigation and CAPA with escalation.
- Support audit/inspection readiness; monitor trends and recommend scalable improvements.
- Perform financial/contractual review (scope alignment, invoice review, accruals, cost modeling, budget variance); advise on cost strategies and operating models.
- Mentor/train VLMs and junior staff; lead functional/CLBM initiatives and represent CLBM in cross-functional forums.
QUALIFICATIONS:
- PhD with 5+ years, or Master’s with 8+ years, or Bachelor’s with 10+ years in relevant areas (project management, clinical/lab/biomarker/specimen or vendor management).
- Relevant experience in pharma/biotech, clinical research, clinical/diagnostic or central/specialty labs, biorepositories, CROs, clinical operations, translational sciences operations, biomarker operations.
- Preferred: PMP certification.
REQUIRED/PREFERRED SKILLS & KNOWLEDGE:
- Clinical drug development; ICF/ICH GCP/GLP; IVDR 2017/746; GDPR; clinical lab specimen handling; assay intended use.
- Biospecimen lifecycle management; informed consent implications; biorepository operations; research-use requests; integrity and disposition.
- Experience managing complex protocols, global vendor relationships, biomarker workflows, and biospecimen data pathways.
- Cross-functional leadership without direct authority; strategic planning, negotiation, operational judgment; risk/quality/compliance execution.
EQUIPMENT & SYSTEMS:
- Microsoft Office; sample tracking/LIMS (e.g., Labmatrix, central lab systems); project tools (e.g., Monday.com, Smartsheet).
Senior Vendor Laboratory Manager (SVLM) within CLBM responsible for program-level laboratory and biospecimen management oversight. Serves as subject matter expert, strategic partner, mentor, and matrix leader to ensure compliant, efficient, high-quality delivery.
KEY RESPONSIBILITIES:
- Lead CLBM delivery across complex/multiple studies/programs; ensure alignment with protocol requirements, timelines, intended use, and decision needs.
- Oversee study start-up, maintenance, close-out, and vendor transition; meet clinical timelines/deliverables.
- Identify cross-study dependencies/risks/process gaps and drive resolution via action plans and stakeholder alignment.
- Provide senior-level oversight of CLBM deliverables, risks, and milestones.
- Lead/sponsor complex vendor relationships and escalations; contribute to sourcing, selection, scope development, contracting, pricing assumptions, and performance oversight.
- Evaluate vendor capabilities/operating models/technologies/assay feasibility.
- Act as SME for assay intended use, biomarker implementation, biospecimen governance, and regulatory expectations.
- Triage/respond to health authority/regulatory questions; consult on residual biospecimen integrity, future use, and disposition.
- Lead resolution of complex quality/compliance/biospecimen/data delivery issues; execute risk mitigation and CAPA with escalation.
- Support audit/inspection readiness; monitor trends and recommend scalable improvements.
- Perform financial/contractual review (scope alignment, invoice review, accruals, cost modeling, budget variance); advise on cost strategies and operating models.
- Mentor/train VLMs and junior staff; lead functional/CLBM initiatives and represent CLBM in cross-functional forums.
QUALIFICATIONS:
- PhD with 5+ years, or Master’s with 8+ years, or Bachelor’s with 10+ years in relevant areas (project management, clinical/lab/biomarker/specimen or vendor management).
- Relevant experience in pharma/biotech, clinical research, clinical/diagnostic or central/specialty labs, biorepositories, CROs, clinical operations, translational sciences operations, biomarker operations.
- Preferred: PMP certification.
REQUIRED/PREFERRED SKILLS & KNOWLEDGE:
- Clinical drug development; ICF/ICH GCP/GLP; IVDR 2017/746; GDPR; clinical lab specimen handling; assay intended use.
- Biospecimen lifecycle management; informed consent implications; biorepository operations; research-use requests; integrity and disposition.
- Experience managing complex protocols, global vendor relationships, biomarker workflows, and biospecimen data pathways.
- Cross-functional leadership without direct authority; strategic planning, negotiation, operational judgment; risk/quality/compliance execution.
EQUIPMENT & SYSTEMS:
- Microsoft Office; sample tracking/LIMS (e.g., Labmatrix, central lab systems); project tools (e.g., Monday.com, Smartsheet).