DescriptionClinical Laboratory & Biospecimen Management (CLBM) is a high-impact partner within the Global Development Organization (GDO), enabling BioMarin's clinical development success through industry-leading vendor oversight and ethical biospecimen management. CLBM implements standardized best practices to ensure the delivery of reliable, high-quality data that supports confident, data-driven decision-making in rare disease development and reduces operational and compliance risk across the clinical development portfolio.
In addition to vendor oversight, CLBM is responsible for the governance and long-term stewardship of clinical trial biospecimens, including biorepository management to support ongoing and future research initiatives.
SUMMARY DESCRIPTION:The Senior Vendor Laboratory Manager (SVLM) is a senior operational leader within CLBM responsible for program-level laboratory and biospecimen management oversight. In addition to independently performing the responsibilities of the Vendor Laboratory Manager, the SVLM serves as a functional subject matter expert, strategic partner, mentor, and matrix leader. The SVLM leads complex programs, resolves high-impact vendor and operational issues, strengthens CLBM tools and operating practices, and influences cross-functional decision-making to ensure compliant, efficient, and high-quality delivery across the clinical development portfolio.
KEY RESPONSIBILITIES:Program -Level Laboratory and Biospecimen Leadership - Lead CLBM delivery across complex studies, multiple studies, or selected programs, ensuring laboratory and biospecimen activities remain aligned with protocol requirements, timelines, intended use, and decision-making needs.
- Provide senior-level oversight of study start-up, maintenance, close-out, and vendor transition activities to ensure clinical timelines and deliverables are met.
- Identify cross-study dependencies, risks, and process gaps and drive resolution through structured action plans and stakeholder alignment.
- Review senior leadership top-line updates and ensure CLBM deliverables, risks, and milestones are accurate, current, and appropriately represented.
Strategic Vendor Management and Operational Oversight- Serve as CLBM lead or senior advisor for complex vendor relationships, high-risk operational issues, and escalations requiring advanced judgment.
- Contribute to vendor sourcing, selection, scope development, contract modeling, pricing assumptions, and performance oversight for central and specialty laboratories.
- Evaluate vendor capabilities, operational models, emerging technologies, and assay feasibility to inform future program needs and vendor strategy.
- Partner with Global Study Operations (GSO), Business Operations, Data Management Sciences, Translational Sciences, Procurement, Legal, Clinical Sciences (CLS), Research, and vendors to drive vendor accountability and delivery excellence.
Scientific, Regulatory, and Assay Intended-Use Expertise- Serve as a CLBM subject matter expert for assay intended use, biomarker implementation, biospecimen governance, informed consent considerations, and applicable regulatory expectations.
- Ensure vendor and assay recommendations consider study protocol objectives, patient management implications, clinical endpoints, regulatory context, and data integrity needs.
- Triage and support responses to health authority or regulatory questions related to biospecimen management, informed consent, laboratory operations, or vendor deliverables.
- Provide scientific and operational consultation on the availability, suitability, integrity, future research use, and disposition of residual clinical biospecimens.
Risk, Quality, Compliance, and Inspection Readiness- Identify and lead resolution of complex vendor, quality, compliance, biospecimen, and data delivery issues across assigned programs or studies.
- Define and execute risk mitigation strategies, corrective actions, preventive actions, and escalation pathways for high-impact operational risks.
- Support audit and inspection readiness by ensuring documentation, decisions, vendor oversight, and biospecimen governance activities are complete, traceable, and inspection-ready.
- Monitor trends across studies and vendors and recommend scalable improvements to prevent recurring issues.
Financial, Contractual, and Business Management- Perform financial and contractual review for assigned programs, including scope alignment, invoice review, accruals, cost modeling, and budget variance assessment.
- Provide senior-level input into vendor cost strategies, laboratory scope assumptions, and operating models that balance quality, compliance, timelines, and cost effectiveness.
- Coach VLMs on financial review, contract interpretation, invoice reconciliation, and escalation of material budget or scope risks.
Functional Leadership, Mentorship, and Capability Development- Mentor, train, and coach VLMs and junior staff in vendor oversight, study execution, risk management, biospecimen governance, financial review, and cross-functional communication.
- Lead cross-functional or CLBM functional initiatives that improve tools, templates, processes, metrics, operating models, standardization, scalability, and inspection readiness.
- Represent CLBM in higher-level cross-functional discussions such as CLS, Data Sciences, central and specialty laboratory strategy, biospecimen governance, and operational excellence forums.
- Lead matrix teams to achieve shared objectives and model leadership behaviors
- Perform other duties related to the CLBM remit as assigned.
QUALIFICATIONS:Education and Experience- PhD degree with life sciences/laboratory background, including biomarkers, and 5+ years of project management, clinical operations, laboratory operations, biomarker operations, specimen management, or vendor management experience; or
- Master's degree with life sciences/laboratory background, including biomarkers, and 8+ years of relevant experience; or
- Bachelor's degree with life sciences/laboratory background, including biomarkers, and 10+ years of relevant experience.
- Relevant professional experience in the pharmaceutical/biotechnology industry, clinical research setting, clinical/diagnostic laboratory, central laboratory, specialty laboratory, biorepository, CRO, clinical operations, translational sciences operations, biomarker operations, or vendor management environment.
- Project Management Professional (PMP) certification preferred.
Advanced Technical and Regulatory Expertise- Strong knowledge of clinical drug development, strategic planning for clinical research, ICF, ICH GCP, GLP, IVDR 2017/746, GDPR, clinical laboratory specimen handling, and assay intended use.
- Strong understanding of human biospecimen lifecycle management, informed consent implications, biorepository operations, research-use requests, specimen integrity, and disposition processes.
- Demonstrated experience managing complex clinical trial protocols, global vendor relationships, laboratory deliverables, biomarker workflows, and biospecimen-related data pathways.
Leadership and Business Capabilities- Demonstrated experience leading cross-functional initiatives beyond assigned studies and influencing decisions without direct authority.
- Strong strategic thinking, scenario planning, negotiation, operational judgment, and ability to build structure from ambiguity.
- Strong understanding and experience with risk identification, mitigation planning, issue resolution, quality management, and execution through close-out.
- Comprehensive understanding of financial and contract documents, including invoice reconciliation, accruals, scope alignment, cost modeling, and budget variance communication.
- Proven ability to mentor staff, develop operational capability, lead matrix teams, and communicate effectively at study, program, and functional leadership levels.
- Project management skills
EQUIPMENT & SYSTEMS- Microsoft Office products including Excel, Word, PowerPoint, Visio, Project, Teams, Outlook, One Note, SharePoint and AI agents.
- Sample tracking/LIMS tools including Labmatrix and central laboratory systems.
- Project management software such as Monday.com, Smartsheet, or equivalent tools.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Ireland Safety Responsibility
Support the organisation's commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.
