Manager, Vendor Support
Manager, Clinical Laboratory & Biospecimen Management, Vendor Support
Department / Cost Center:
Clinical Laboratory & Biospecimen Management
Reports to (Job Title):
Executive Director, Clinical Laboratory & Biospecimen Management
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 four groups: 1.) Study Operations & Sample Request, 2.) Technical Operations, 3.) Vendor & Operational Performance Support and 4.) Vendor Support. The 4 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 Manager reports to the Executive Director of CLBM and is a critical leadership position in CLBM that oversees the Vendor Support group and participates in key CLBM internal initiatives. The Manager demonstrates foundational/advanced level of independence in engaging cross-functional colleagues to assist in sourcing activities, financial reviews and determining if there is a need for specialty lab services and the related scientific and operational criteria for laboratory selections. The Manager’s responsibilities also include partnering with other CLBM groups, cross-functional colleagues and cross-functional working groups to develop optimized business processes and workflows to achieve department and corporate goals.
At the Manager level, this individual should demonstrate foundational/advanced abilities across multiple core competencies: Communication, Problem Solving, Planning, Teamwork, and Proactivity. Likewise, the Manager needs technical skills across several key central competencies for CLBM, which include: Project Management, Central and Specialty Lab Vendor Management, Biospecimen Management, Finance and Budget Tracking and Management, and Vendor Sourcing/Selection.
The Manager, CLBM Vendor Support position is a key leader in the CLBM Management Team and participates in strategic and leadership meetings and discussions. A Manager has begun demonstrating foundational/advanced of relevant biospecimen technical content and can be relied on to take on a range of possible roles, including:
• Vendor Support Roles: The manager will be part of the CLBM team that is involved in various vendor sourcing activities, financial reviews and metric generation along with interfacing with the various scientists to obtain needed vendor information for specialty lab selection. The manager will partner with Biospecimen Operations Managers (BOMs) and Biospecimen Operations Associates (BOAs) to support the management of central and specialty labs as related to sourcing, contract review, analyte and specialty lab selection.
The Manager, CLBM Vendor Support, will also take on leadership roles focused on developing relevant SOPs and WIs in collaboration with CLBM’s Vendor & Operational Performance Support group and training of BOMs on pertinent contract financial tracking.
The Manager, CLBM Vendor Support, may manage a small team in the future.
The Manager, CLBM Vendor Support, has demonstrated foundational/advanced skills, at a minimum, in all relevant core competencies and likewise has demonstrated foundational/advanced skills of most technical competencies.
Central Lab/Specialty Labs
- Serve as BOM for one program or select studies as necessary.
- Collaborate with Senior Biospecimen Operation Manager (s) and/or Associate Director to track historical performance of central and specialty labs to help CLBM team make informed sourcing decisions.
- Collaborate with CLBM Vendor & Operational Performance Support group to develop SOPs and WIs related to financial and contractual review.
- Collaborate with CLBM’s Technical Operations and Study Operations & Sample Request groups to develop solutions that build efficiencies in vendor support processes.
- Perform financial and contractual review in support of all BOMs.
- Observe trends and inconsistencies and then identify and recommend standardized sourcing, contracting and financial processes for CLBM as well as with cross-functional groups.
- Play a leadership role at Business Review meetings (e.g., contract/budget meetings and Joint Operation Committees [JOC]) for all relevant vendors.
- Interact with scientists in BioAnalytical Sciences and Clinical Genomics to define and identify the appropriate biospecimen type for a planned analyte and its associated assay that needs to be performed by a specialty lab that is recommended by our scientific colleagues as dictated by the protocol.
- Generate, provide and store relevant metrics and performance perspective in support of Executive Operation Committee (EOC) meetings and to support internal cross-functional colleagues requests.
- Take a leadership role in smaller CLBM functional improvement projects and/or participate in major functional or cross-functional initiatives.
- Coach BOMs on review of contracts and budgets.
The Manager, CLBM Vendor Support, will work closely with the CLBM team and other cross-functional groups such as: Development Sciences Business Operations, Global Strategic Sourcing, Clinical Operations/GMAF Study Management, Clinical Data Management, Legal, Development Sciences Quality, Translational Sciences, and other Development Sciences teams as well as external Labs.
This section is for external use. When using this template to create an external job posting, remove the Level of Mastery Expectations tables below.
The Manager, CLBM Vendor Support should demonstrate foundational/advanced skills in Leadership, Problem Solving and Decision Making, and Influencing and Persuasion. In order to be successful in the role, the Manager must be able to:
- Successfully mediate conflict, develop rapport with decision makers, and solve problems in a big-picture and stakeholder-supported way.
- Foster mutually beneficial working relationships and skillfully leverage recognition of team values and goals for motivation.
- Motivate and empower teams, including by inspiring individuals, gaining buy-in, and adjusting style to the needs and maturity level of the team.
Individuals in this role are also expected to have foundational/advanced variety of technical competencies, including Biospecimen Management Processes, Vendor Management and Lab Operations, and Good Practices and Compliance. This includes:
- Knowledge of CLBM best practices and an ability to leverage this knowledge to lead continuous improvement efforts within and outside of the CLBM team.
- Deep familiarity with potential for vendor “push-back” on escalated issues and an aptitude for resolving these issues effectively and efficiently.
- Understanding of the regulatory environment, relevant changes, and their impact on study design, execution, and biospecimen-related processes.
COMPETENCIES: LEVEL OF MASTERY EXPECTATIONS
This section is for internal use.
BioMarin has defined core and technical competency expectations for each title within Clinical Laboratory & Biospecimen Management. These expectations are outlined in the Competency Matrices. Please refer to the matrices and detailed levels of mastery descriptions for more detail.
Below is a high-level summary of the core and technical competency expectations:
Mastery: Extensive, expert-level understanding and proven performance in the skill area
Advanced: Comprehensive level of knowledge and skilled execution in the skill area
Foundational: Strong baseline understanding and demonstrable implementation of the skill area
In Development: Early performance of competency and development of the skill area
Core CompetenciesTechnical Competencies
Problem Solving and Decision Making: F/A
Influencing and Persuasion: F/A
Planning, Prioritization, and Organization: F/A
Teamwork and Relationship Building: A
Proactivity and Initiative: F/A
People Management: F/A
Biospecimen Management Processes and Logistics: F/A
Vendor Management and Lab Operations: A
Good Practices and Compliance: A
Drug Development, Study Design, Study Execution and Therapeutic Area: F/A
IT, Biospecimen Systems, and Data Analysis: F/A
Vendor sourcing, contracting and financial review: F/A
Project Management: F/A
Opportunities for Career Development are outlined in the CLBM Career Pathway Overview.
This role may manage up to 2 direct reports at some time in the future.
EDUCATION AND EXPERIENCE
- BA/BS in life sciences or related degree. Advanced degree preferred. Project/program management preferred. Experience in lieu of education accepted.
- 8 years of relevant experience working in the pharmaceutical industry (including CROs, study sites, central labs, specialty labs, and biorepositories).
- 4 years of relevant technical experience working with biospecimen management, lab management, biobanking, biomarker operations or similar organizations.
- 4 years of relevant vendor management experience including contracting, financial review, meeting management, timeline tracking, deliverables and risk management.
- At least 1 year of people management experience.
WORK ENVIRONMENT / PHYSICAL DEMANDS / TRAVEL
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
- Computer work utilizing common business software programs.
- Experienced in the following software: Microsoft Office Products, Visio, Project Management, SharePoint, Labmatrix (track biobank biospecimens and processes) and Monday.com.
- Internal: Information Technology (IT), Development Sciences Operations (DSO), Legal, Compliance, Data Management (CDM), Translational Sciences (TS), Regulatory Affairs, Biomarker Discovery, Research, Global Medical Affairs (GMAF), Finance, Human Resources.
- External: Vendor personnel, counterparts or appropriate team members at partner companies, candidates for open positions.