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Director, Clinical Laboratory & Biospecimen Management

Location San Rafael, California Workstyle Open to Hybrid
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

SUMMARY:

Clinical Laboratory & Biospecimen Management (CLBM) is part of BioMarin’s Development Sciences Operations (DSO), which coordinates the execution of the various phases of clinical trials during drug development.  CLBM is comprised of three groups: 1.) Study Operations & Sample Request, 2.) Technical Operations and 3.) Vendor & Operational Performance Support. The 3 CLBM groups either directly manages or supports the management of the central and specialty laboratories and tracks biospecimens (human) from collection to their final disposition. CLBM accomplishes these activities by ensuring all processes and procedures are efficient, effective, well-documented and align with the protocols, informed consents, testing requirements and protocol timelines.

The Director in CLBM oversees the Study Operations & Sample Request group and reports to the Senior Director of CLBM. The Director is a leadership position within CLBM and has extensive experience in the following areas: Clinical Trial Operations, Procedures and Regulations; Biospecimen Management, Vendor Sourcing & Contracting, Informed Consent (ICF) Design & Interpretation, Central and Specialty Lab Testing and Management; Strategic Planning; Biospecimen Inventory System Use; and Shipping and Custom Regulations.

As a seasoned and well-respected leader, the Director plays a pivotal role in setting the direction of the Study Operations & Sample Request group within CLBM and collaborates continuously with CLBM’s other groups, i.e., Technical Operations and Vendor and Operational Performance Support. The Director assists Technical Operations in utilizing and improving CLBM’s systems and technologies. Likewise, this position also works closely with Vendor & Operational Performance Support group to develop all BioMarin biospecimen governing documentation. H/She is also a key contributor to cross-functional activities needed to successfully execute on clinical trials, operational improvement, and change initiatives that impact biospecimen and central and specialty laboratory management.

CLBM’s Study Operations & Sample Request group is responsible for working with Clinical Operations/GMAF Study Management, Development Sciences Business Operations, Clinical Data Management, Legal, GCP Compliance, Development Science Quality, and research teams to ensure a smooth process flow for all biospecimen-related activities. 

RESPONSIBILITIES:

  • Be a strategic, scientific and service pricing SME during vendor sourcing and selection process for new or existing central and specialty labs or other vendor types as needed as considered for BioMarin clinical trials.
    • Act as a primary stakeholder with others in CLBM, as needed, in the central and specialty laboratories sourcing process that includes identification, evaluation, and selection of new vendors that would be the best fit for each study’s needs and documenting recommendations and decisions.
      • Including participating in “virtual” and in-person operational visits, when scheduled.
    • Define and clarify cross-functional expectations during sourcing and management of central and specialty labs so that standardized practices and procedures can be implemented.
    • Leverage input for more accurate price alignment between central and specialty lab cost proposals with actual biospecimen and testing needs.
    • Participate on conference calls with biobank vendor or any vendor as a SME or a point of escalation, as needed.
  • Advise CLBM and cross-functional staff on central and specialty lab vendor management using “BioMarin’s best practices” when new protocols are starting especially as related to contracting and subcontracting scenarios.
  • Be a point of guidance and/or escalation for existing central and specialty laboratories to address any operational questions/issues that may arise and need to be resolved or triaged to the appropriate individual or cross-functional group.
    • Review various documents and plans to ensure BioMarin’s and vendor’s expectations are aligned and standardized, so vendor performance and quality metrics are developed, agreed to and implemented.
    • Join as needed in vendor conference calls on relevant topics.
    • Review, access and escalate, when necessary, unresolved operational issues to JOC and/or EOC Chair and other cross-functional teams, as needed.
    • Be available as a SME and/or coach for vendor invoice review and payment from the internal accounting system and provide input to CLO/GMAF study management for their final approval of pending invoices.
  • Provide guidance and act as the interface to CLBM and BAS/TS staff for assays in early development to be added to protocol testing or to seamlessly transition testing of clinical biospecimens BAS/TS to a specialty lab
  • Participate in Study Execution Team (SET) and other cross functional meetings as an adhoc member throughout the life cycle of a clinical trial to provide input, if needed:
    • On escalated vendor and biospecimen handling issues.
    • On escalated decisions regarding biospecimen collection, processing, storage, and shipping; kit design, data deliverables and contract modifications.
      • Be well-versed in International Air Transport Association (IATA) and Customs Regulations for biospecimen and ancillary supply shipments.
    • Participate in defining and periodically reviewing study-related data in the clinical biospecimen inventory tracking system.
      • Review the standardized inventory data template and maintain all planned biospecimen-relevant information, i.e., relevant details for each biospecimen type collected.
      • Acts as the Business Owner of CLBM systems – provides business requirements for system operational design and enhancements.
    • Perform steward duties for Analysis Request (AR), if needed.
      • Be the point of contact with BAS/TS colleagues that have questions about availability and suitability for future research use of residual clinical biospecimens.
      • Has a strong scientific background in a relevant field to appreciate biomarker discovery research topics that are relevant to AR review for future research.
      • Participate in inquiries related to the appropriateness or integrity of biospecimens, work with CLBM Stewards on disposal requests as appropriate.
    • Participate in CLBM process improvement projects, as needed.
    • Be the project manager for the Biospecimen Authorization Committee (BAC) who oversees the ethical use of clinical biospecimens.
    • Recommend strategic goals to CLBM and Development Sciences Operations senior management.
    • Be the chair of the Biospecimen Core Working Group to obtain cross-functional input from BAS/TS, Legal, GCP, and RDQ on biospecimen-related issues or assessment of BioMarin’s approach to new regulations.
      • For example, ICF wording for biospecimen-related sections to ensure standardization across all BioMarin protocols.
    • Be an effective staff career developer and coach that aligns with CLBM’s strategic plans.


Experience:

Required Skills:

The Director of Study Operations and Sample Request is expected to demonstrate mastery level (extensive, expert-level of understanding and proven performance) in the following Core Competencies: Leadership, Communication, Problem Solving and Decision Making, Influencing and Persuasion, Planning, Prioritization, and Organization, Teamwork and Relationship Building, Proactivity and Initiative and People Management including:

  • Actively contributing to cross-functional team definition of goals, roles and tasks.
  • Proactively expanding one’s network and work relationships outside the department.
  • Ability to create inclusive and collaborative cross-functional team and meeting environments.
  • Ability to recognize and articulate and prioritize key issues that arise based on understanding of objectives so that issues are resolved.
  • Ability to analyze and evaluate problems and seek-out and recommend possible solutions before escalation.
  • Leveraging data effectively to communicate points of view and influence outcomes.
  • Effectively lead meetings, track action items.

Desired Skills:

The Director should demonstrate a mastery level of knowledge (extensive, expert-level of understanding and proven performance) across all primary technical competencies, including Biospecimen Management Processes & Logistics, Vendor Management & Lab Operations, Contracting, Sourcing, ICF Review, Clinical Trial Operations, Shipping and Custom Regulations, Budget Generation and Review, Project Management, and Lab Operations, Good Practices and Compliance, and Drug Development, Study Design & Study Execution, and IT, Biospecimen Systems & Data Analysis. Specifically, this includes:

  • Understanding of end-to-end biospecimen management lifecycle, i.e., biospecimen collection, processing, storage, shipping and destruction.
  • Understanding of informed consent and its impact on biospecimen management.
  • Understanding of managing central and specialty lab’s handling of biospecimens, biospecimen collection kits, protocol deliverables, timelines and test results as related to the 3 phases of a clinical trial, i.e., Protocol Concept & Study Start-up, Enrollment & Maintenance, and Close-Out Phases.
  • Understanding of GxP principals and how they impact biospecimen operational and vendor management activities, and what appropriate steps and path need to be taken to escalate.
  • Understanding of study protocol objectives and methodology.
  • Understanding of financial documents for review, standardization and coaching.

Education:

  • BA/BS in life sciences or related degree. Advanced degree preferred. Experience in lieu of education accepted.
  • 12 years of relevant experience working in the pharmaceutical industry (including CROs, clinical sites, labs and biorepositories).
  • 6 years of relevant technical experience working with biospecimen management, lab management, biobanking, or similar organizations.
  • At least 5 years of people management and coaching experience.


PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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