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 Operations (DSO) 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.
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 global clinical trials, including strategic vendor management, clinical financial spend analysis and management, vendor contract management and clinical site 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 budgets and vendor contracts, as well as facilitates effective vendor oversight.
The Business Operations Group consists of several subgroups that operate collaboratively to provide distinct specialist skills in support of BioMarin’s global clinical development.
The Clinical Contracts & Grants (“CC&G”) subgroup is responsible for developing and managing site budgets and supporting site contract negotiations either directly or through managing a CRO, as well as collaborating with other Business Operations colleagues on forecasts and related scenario analyses for all BioMarin clinical studies.
Key responsibilities include: site scenario planning during site selection and study start-up; site budget development and related negotiation; assisting with site forecast calculation; and, site budget amendment updates. Key deliverables are the site budgets and site contract support, as well as key metrics for measuring site financial performance.
Within Business Operations, the Manager is a critical position focusing on leading CC&G activities across a portfolio of studies and projects, including site budget development and negotiations. The Manager will also be a contributor to the broader Business Operations project portfoliofinancial strategy and planning by supporting site budget analysis and forecasting. It is expected that the Manager would mentor the site budget development and negotiation activities of junior staff members and may have direct reports in the future.
Site Budgets and Clinical Trial Agreements:
The Manager may be assigned one or more complex studies and be expected to manage the following for each study and/or sites involved in the study:
Budget analysis and assessment;
Reviewing protocol synopses and draft protocols to understand procedures and schedule of patient assessments to identify key cost drivers; and
Leveraging best practice databases and historical site costs data to derive estimated per patient costs for study team planning.
Site budget development:
Determining appropriate budget line items based on final protocol;
Developing study budgettemplate and obtaining study team approval;
Negotiating or managing CRO negotiation of site budgets for all sites on assigned studies;
Leveraging benchmark pricing database (Grants Manager), historical price data and sound financial judgement to determine budget line item costs;
Calculating acceptable negotiation parameters for all key budget line items (high, mid, low) that are in line with and support BioMarin’s overall financial goals; and
Collaborating with Study Teams to finalize budgets for submission to Sites/CRO.
Supporting the budget negotiation for each site in partnership with the Study Teams;
Providing rationale for all budget line items and promptly responding to any site or CRO queries regarding budget items;
Proactively driving sites and CROs to reach agreement on budget line items in line with approved budget parameters;
Working with Study Teams, sites and CROs to resolve disagreements on budget line items, and escalating, as appropriate, where agreement within parameters cannot be reached;
Tracking communication and status of all site budget development, budget amendments and budget negotiations; and
Advocating for appropriately controlling costs in line with corporate objectives in all site budget negotiations.
Ongoing Budget maintenance:
Building and maintaining strong relationships with Study Teams, CROs, and sites in order to maintain awareness of any changes that may impact budgets or site and/or vendor contracting;
Attending study team meetings/CRO calls to gather information that may impact budget development and management;
Acting as primary contact for all internal and external questions regarding site budgets and related parameters;
Updating all site budgets based on protocol amendments; and
Collaborating with Study Teams to transition all legacy budgets to CC&G group for maintenance going forward.
Clinical Trial Agreements:
Collaborating with the Legal Department to draft, negotiate and complete the Clinical Trial Agreement (CTA) package (including approved budgets) for each site;
Acting as first point of contact for any CTA-related questions from sites/CROs;
Escalating any legal feedback to the Legal Department, as appropriate;
Facilitating internal contract approval and stakeholder negotiation to resolve complex issues and assist in disputes;
Reviewing existing Clinical Trial Agreements (CTAs)/budgets to gauge performance and identify where improvements can be made; and
Evaluating terms and conditions of contracts using Legal Department-approved playbooks, driving contracting process, and escalating to Legal Department, as appropriate.
Supporting the reconciliation of site payments with responsible parties, including Study Team and BioMarin’s third party payment vendor (DrugDev);
Supporting junior staff in efforts to collaborate with Clinical Operations to address and resolve any queries or issues regarding payment to sites to optimize the value of site payment vendor relationship;
Serving as subject matter expert and liaison to BioMarin’s site payment process vendor for all site budget related matters; and
Serving as initial point of escalation for site budget related items that impact site payments.
Managing the vendor relationships with site payment and patient travel vendors including:
establishing communication and collaborative work practices;
establishing performance metrics;
facilitating resolution of any vendor issues; and
leading vendor contracting and change requests.
Process Development and Improvement:
Participating in the development and implementation of the CC&G process/workflow for the completion of site budgets;
Leveraging industry best practices to define processes and create/update appropriate documentation (e.g., work instructions);
Providing training and continuous support to CC&G team on using the Grants Manager (GM) planner system; and
Partnering with other Business Operations colleagues to optimize use of site data in BioMarin’s analytics program.
Individuals in the Manager role are expected to demonstrate advanced proficiency in the areas of communication, planning and prioritization, teamwork and proactivity. This includes:
an ability to distill and articulate complex issues to a wide range of audience types; and
proactively identifying opportunities for operating more efficiently.
The Manager also demonstrates growth in technical competence with advanced skills in clinical trial agreements and site financial management, including:
understanding basic study protocol objectives, methodology, biostatistical concepts and data analysis;
observing site financial performance across all sites for a study to identify potential issues and escalate as appropriate;
understanding and applying appropriate methods and tools (historical data, GM) for conducting site budget planning analysis;
working collaboratively with technology teams to implement changes in technology to support budget development and tracking; and
adeptly analyzing metric data and articulating any data issues.
EDUCATION AND EXPERIENCE:
BA/BS in finance/accounting, life sciences or related degree with 4+ years of relevant experience working in the pharmaceutical industry (including CROs) or relevant experience working in an academic medical center - OR - Master's degree with 2+ years of relevant experience working experience.
2+ years of relevant technical experience working with project and study financial forecasts.
2+ years experience in a supervisory role.