Manager, Development Sciences Business Operations - Vendor Management, Clinical Operations - United States
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.
BioMarin’s Development Sciences group is responsible for everything from research and discovery to post-market clinical development. Development Sciences 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. Come join our team and make a meaningful impact on patients’ lives.
Overview: Development Sciences Business Operations
The Development Sciences Business Operations (Business Operations) Group is the center of excellence for providing industry best practice operational support for the conduct of BioMarin’s clinical trials, including vendor management, clinical financial spend analysis and management, contract management and clinical site and vendor contract and budget support. The group utilizes rigorous processes, procedures, and tools to ensure financial discipline and transparency in vendor spend, assists with financial and resource projections across clinical projects and studies, manages the development, negotiation and execution of clinical site and vendor contracts, as well as facilitates effective vendor oversight.
The Business Operations Group consists of several teams that operate collaboratively to provide distinct specialist skills in support of BioMarin’s Clinical Development.
The Strategic Vendor Management team is responsible for leading the establishment and on-going health of our service provider relationships. This team manages vendor relationships, governance, performance, and quality at the portfolio level, as well as playing a key role in vendor selection activities. This includes vendor due diligence, scope and budget negotiations, relationship building and maintenance, assessing and managing vendor performance, serving as an escalation point, and communicating with vendors. The relationship manager is responsible for coaching and guiding the vendor on how to best collaborate to build a healthy, long-term partnership with BioMarin.
The Manager typically leads relationship management for a high volume of Tier 2 and 3 vendors. The Manager’s tasks include managing vendor scoring, participating in vendor selection activities, leading the Business Operations vendor on-boarding activities, reviewing and presenting to clinical study teams on vendor KPIs, serving as a liaison in communications with the vendor, acting as a point of escalation for issue resolution, and delivering trainings to the clinical study teams.
Following demonstrated success in the role, the Manager may have opportunities for increasing cross-functional influence and responsibility, including assignment to additional Tier 2 vendors and some Tier 1 vendors.
Manage vendor scoring process.
Lead vendor on-boarding activities.
Generate and maintain vendor management central file documents.
Ensure alignment between the vendor and clinical team on expected deliverables and quality.
Work closely with vendors to help them understand and adopt BioMarin governance processes and materials.
Ensure vendor management central file is “inspection ready” at all times and document BioMarin Sponsor oversight.
Facilitate business review meetings for Tier 1 and 2 vendors, including agenda development and pre-meeting reviews of vendor presentation materials.
For assigned vendors, collaborate with Global Strategic Sourcing (GSS) and Vendor Selection Team in performing activities including: defining required vendor services; providing feedback on existing vendors; defining vendor selection criteria; and proposal review and due diligence.
Facilitate and/or manage requests to/from vendors for additional detail on capabilities, assumptions, costs or other term in order to effectively compare multiple proposals/bids (for competitive bids).
Negotiate budget and scope with vendors, as appropriate.
Vendor Performance Management:
Responsible for portfolio-level identification of trends, quality management, and risk mitigation, including receiving KPI reports and audit reports.
Proactively address issues and risks escalated from the functions and guide the vendor toward improvement.
Monitor vendor KPIs.
Develop tools for assessing vendor performance.
Conduct vendor performance assessment (VPA) and share outcomes with GSS and the Vendor Selection Team as part of vendor selection process.
Vendor Relationship Management:
Act as point of escalation for issue resolution, including performance, compliance, and financial issues to ensure the study stays on track and on budget.
Communicate results of VPAs to key stakeholders and provide recommendations to improve the relationship.Maintain awareness of vendor status, trends, and high-level risks through regular communication with vendor counterpart.
Communicate via monthly relationship status report to Executive (Tier 1) and Senior (Tier 2) Sponsors.
Assist the vendor in connecting with key stakeholders and other divisions to help build vendor’s portfolio and ensure success across BioMarin.
Develop training and reference materials for use primarily by the clinical project teams.
Deliver training to vendor on BioMarin governance, business processes, and KPI metric reporting.
Attend clinical study team meetings and other DevSci forums as required.
Coordinate with others in Business Operations to drive vendor accountability and quality of deliverables.
Individuals in the Manager position are expected to demonstrate advanced core competence in the areas of communication, planning and prioritization, teamwork and proactivity. This includes:
an ability to distil and articulate complex issues to a wide range of audience types
proactively identifying opportunities for operating more efficiently.
The Manager also demonstrates foundational leadership skills by motivating teams, and helping them clarify goals, tasks and responsibilities.
In addition, the Manager must have established an advanced understanding of Drug Development and Study Design, as well as and Vendor Performance and Quality Management. This includes the application of GCP principles to vendor performance and an ability to resolve escalated vendor issues.
No people management responsibilities.
Education and Experience:
- BA/BS. Experience in lieu of education considered.
- Clinical Operations, Project Management, Clinical Outsourcing, and/or Service Provider management experience required. Process Improvement, Change Management, Clinical Quality Management experience is a plus.
- At least 5 years’ experience in a pharmaceutical or CRO (drug development) environment with knowledge of all stages of drug development, clinical operations, clinical outsourcing, and Good Clinical Practice.
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 and fingers; 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.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.