Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD 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 genetic diseases.
Role OverviewKey responsibilities for assigned programs:- Overall accountability for site-budget related financial management including executing on the global site budget and contracting strategy, overseeing all site-budget related financial activities and deliverables
- Responsible for the development of complex global site budget templates and leading budget negotiations directly with sites, or managing teams for outsourced negotiations through CRO/vendor to achieve business objectives
- Primary point of contact (POC) for site budget and CTA management, responsible for compiling CTA agreement packages in collaboration with key stakeholders and resolving any site-specific budget, contract or payment issues
- Responsible for managing the overall site budgeting processes including site payment vendor for assigned programs
- Responsible for identifying, developing and implementing relevant process improvements and driving strategic contract strategies
- Act as the BizOps SME, providing expertise on the impact the study protocol, schedule of events (SOE’s) and assessments will impact budget cost drivers
- Proactively leverage previous experience to accelerate contracting process and operationalization of SOE tasks into Fair Market Value
- Advanced understanding of country requirements as related to site budgets and contracts, study participant stipends/travel reimbursements, and payments, directly or through CRO and payment vendor relationships
- Be able to lead discussions with cross-functional departments involved in, or impactful to, clinical contracts, budgets or payments
- Ensure relevant knowledge and expertise in current industry best practices and standards for fair market value evaluation, budget build and negotiation, and site payments
- Quantifies and/or qualifies impact of gaps, risks and liability to programs or business and takes the necessary steps to mitigate or address
Detailed ResponsibilitiesSourcing and Selection- Selection/Feasibility - provide advice and expertise regarding site selection and feasibility (timelines, cost, budget/contracting relationship, budget negotiation)
- Start-up - coordinate with GSO, CRO, GPM, and Legal to establish and align on site budgets and CTAs prioritization / start-up timeline
- Reference Materials -- protocol, SET, BizOps forums, BOARD
Budget Development- Budget analysis and estimation:
- Review protocol synopses and draft protocols of increased complexity to understand procedures and schedule of patient assessments to identify key cost drivers
- Identifies issues, areas of financial risk or opportunity to facilitate scenario development or savings opportunities for study and BioMarin
- Leverage deep understanding alongside available bench marking tools and historical site cost data to derive robust per patient cost estimates for study team planning
- Site budget development:
- Demonstrates comprehensive understanding of protocol defined services and the relationship to investigator site / CTA and financial budgets
- Determine and advise on appropriate budget line items based on final protocol
- Develop study budget template and payment strategy, and obtain study team approval
- Collaborate with key stake holders (GSO, CDM) to develop payment strategy, with the goal of streamlining invoicing and mitigating overpayments
- Draft country level budget templates, where required
- Complete or oversee completion of advanced site-benchmarked budgets for all sites on assigned studies
- Thorough knowledge of the available bench marking tools, alongside the ability to leverage historical price data whilst using sound financial judgement to determine appropriate budget line item costs
- Site budget development continued:
- Ability to independently calculate acceptable negotiation parameters for all key budget line items that are in line with and support overall BioMarin financial goals
- Collaborate with GSO to finalize budgets for submission to regulatory bodies, sites, and/or CRO
- Budget Negotiation
- Lead budget negotiation for each site, collaborating and driving discussion with study team members as necessary
- Provide clear rationale for all budget line items as required and promptly respond to any site or CRO queries regarding budget items
- Proactively drive sites and CROs to reach agreement on budget line items in line with approved budget parameters and timelines
- Hold study Teams, sites and CROs accountable to deliverables and resolution of budget fee disagreements,
- Act as a key escalation point if agreement within parameters cannot be reached with study teams, sites or CRO
- Track communication and status of all site budget development, budget amendments, and budget negotiations in BOARD system
- Exhibits a focus on performance measurement to track progress toward objectives and timelines
- Advocate for the appropriate controlling of costs in line with corporate objectives in all site budget negotiations
- Observes site financial performance across all sites for a study to identify potential issues and escalates as appropriate
- Advise stakeholders (SET/GSO/CRO/REG) on budget-related risks to timelines, potential mitigations, and align on prioritization of cost vs speed when needed
- Ongoing Budget Maintenance
- Build and maintain strong relationships with SET, CRO, and sites in order to maintain awareness of any changes that may impact budgets or site and/or vendor contracting
- Attend relevant study team meetings/CRO calls to gather information that may impact budget development and management and provide effective outcome and resolutions
- Act as primary contact and expert for all internal and external questions regarding site budgets and related parameters
- Evaluate need for budget amendment based on all protocol amendments according to established process, and ensure all site budgets are updated in a timely manner, when required
- Process site amendments as applicable based on study protocol or site updates
- Reference Materials
- Protocol, Site List, Contract Lifecycle Management System, BOARD; Sites contracts capsule
Clinical Trial Agreements- Collaborate with Legal to draft, negotiate and complete the Clinical Trial Agreement (CTA) package (including approved budgets) for each site
- Act as first point of contact for any CTA-related questions from sites/CROs
- Facilitate stakeholder negotiation and internal contract approval to resolve escalations or complex issues
- Review existing Clinical Trial Agreements (CTA) to gauge potential risk and identify improvement opportunities
- Implement contracting process and negotiations by managing site agreements (using CTA template), conducting moderately complex contract negotiations directly with sites and vendors, and tracking all activities using BioMarin’s Contract Lifecycle Management System and BOARD
- Evaluate terms and conditions of contracts using Legal Department-approved playbooks, drive contracting process, and escalate to Legal Department, as appropriate
- Ensure all contract versions are provided to Legal for entry to BioMarin’s Contract Lifecycle Management System, and filed in appropriate BizOps’ filing system(s) as necessary
- Upload executed contract/budget to DrugDev (DD) SharePoint to trigger system set up/payments
- Process site amendments as applicable based on study protocol or site updates
Site payments- Collaborate with GSO, CDM, and payment vendor to establish data driven payments in accordance with established processes that address visit budget template (VBT), payment triggers, EDC vs. Secondary sources, etc.
- Attend ongoing payment vendor meetings
- Facilitate the reconciliation of site payments with responsible parties during maintenance and closeout
- Partner/collaborate with GSO to address and resolve any queries or issues regarding payment to sites to optimize the value of site payment vendor relationship
- Support study closeout according to established process
Oversight and Management- Forecast - Update Total Contract Value (TCV) and monitor study assumptions to ensure alignment between budget CTA and study forecast
- Reference Materials - SET/BizOps forums, TCV table
- Payments - Support GSO on the Investigator Payment Process for Site Activity Review and Approval (SARA) funding
- Reference Materials - TCV Table, DD VBT
- Execute payment vendor change orders as appropriate
- Exhibits a focus on performance measurement to track progress toward objectives
- CRO oversight - Sets the context for work tasks by linking to functional / corporate goals and objectives
- Facilitates small and large meetings efficiently and effectively across functions
- Distills complex issues to simple terms for all skill levels; drives information dissemination up and down the organization and within the CRO to influence appropriate outcomes
- Focuses on operational efficiency, ensuring procedures are in compliance and inefficiencies are identified, acted on
Site Vendor Management- Manage the vendor relationships with site payment vendor; facilitate resolution of any vendor issues; lead contracting and change requests efforts
Process Development and Improvement- Play a key role in developing and implementing the Site Contracts and Budget process and workflow for the completion of site budgets; leverage industry best practices to define processes and create / update appropriate documentation (e.g., work instructions, process documents)
- Identify and provide ongoing feedback on key metrics to measure and monitor performance; support development mechanisms for tracking and reporting efficiency and accuracy of site contracts and budget development
- Strives to improve data quality and data standards to support financial reporting objectives
- Identify opportunities to partner with cross-functional stakeholders to optimize use of company resources and align on standards/processes, and tools/systems (such as EDC, benchmarking databases, negotiation tools, etc.)
- Holds team or function accountable for goal achievement and high performance by creating a shared sense of ownership for success, ensuring positive and supportive morale
System Optimization- Provide training and continuous support to new BPSM team members on use of internal and external financial systems
- Monitor and oversee updates to Office360/LiveLink database of existing CTAs and budgets, providing access to GSO and additional stakeholders
- Partner with Analytics / DSA to optimize use of site data in BioMarin Analytics program
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.
