Senior Vendor Laboratory Manager Clinical Laboratory & Biospecimen Management

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San Rafael

BioMarin Pharmaceutical

Senior Vendor Laboratory Manager Clinical Laboratory & Biospecimen Management

Location: San Rafael, United States

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Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on peopleâ€s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our R&D engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.

Clinical Laboratory & Biospecimen Management (CLBM) is a high-impact partner within the Global Development Organization (GDO), enabling BioMarinâ€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.

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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.

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SUMMARY DESCRIPTION:Â

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.Â

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KEY RESPONSIBILITIES:

Program â€"Level Laboratory and Biospecimen LeadershipÂ

• 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.

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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
• Masterâ€s degree with life sciences/laboratory background, including biomarkers, and 8+ years of relevant experience; or
• Bachelorâ€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.

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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.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility

Support the organisationâ€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.

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Recruitment Fraud Alert Notice

Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.

In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.

If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.

For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, email Applicant_accommodations@bmrn.com with your request.

This email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team â€" please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us at talentacquisition@bmrn.com.

Applicants, please do not use this email address to submit resumes â€" if you do so, you will be redirected to apply through the website.

Click here to review "EEO Is The Law" poster. Click here to review the Pay Transparency Nondiscrimination Statement. Click here to review the Notification of Employee Rights under Federal Labor Laws.

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