Strategic R&D Business Operations Manager
Description
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.
The Manager, Development Science Business Operations will also contribute to the overall clinical portfolio business operations activities including vendor contracting management and financial management of clinical trials.
Key responsibilities for assigned programs include but are not limited to the following:
- 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
- Aligning with Global Study Operations on the clinical trial strategy in order to successfully contribute to trial execution
- Primary point of contact (POC) for site budget and Clinical Trial Agreement (CTA) management, responsible for compiling CTA agreement packages in collaboration with key stakeholders and resolving any site-specific budget, contract, or payment issues.
- Develop clinical trial assumptions and program drivers and drive delivery of the milestones and metrics.
- Selection/Feasibility - provide input into site selection and feasibility (limited to contracting timelines, cost, budget/contracting relationship, budget negotiation)
- Determine appropriate budget line items based on final protocol
- Develop study/country/site budget template from the Protocol Schedule of Assessments, suitable payment strategy, and obtain study team approval
- Budget analysis and estimation. Leverage available bench marking tools, historical data and sound financial judgement aligned with fair market value principles to determine budget line-item and patient visit proposed costs
- Proactively drive sites or CROs/vendors used for site contracting to reach agreement on budget line items in line with approved budget parameters
- Draft country and site CTAs and act as first point of contact for any CTA-related questions and escalations from sites/CROs
- Implement contracting process and negotiations by managing site agreements (using CTA template), conducting moderately complex contract negotiations directly with sites and CRO/vendors in coordination with Legal, and tracking all activities using the company’s software systems
- Ensure all contract versions (including final executed CTA) are adequately tracked, and filed in the appropriate filing system(s) as necessary
- Process site amendments as applicable based on study protocol or site updates
- Support and facilitate the reconciliation of site payments with responsible parties during maintenance and closeout using established processes
- Maintain awareness 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.
- Supporting vendor/CRO performance oversight for outsourced work
- Advise internal stakeholders on budget-related risks to timelines, potential mitigations, and align on prioritization of cost vs speed when needed
- Liaise with cross-functional departments involved in, or impactful to, clinical contracts, budgets or payments.
Must have: Minimum Requirements:
Education:
- BA/BS in finance, accounting, health sciences, or related degree. Advanced degree preferred. Experience in lieu of education is considered.
Experience & Key Competencies
- 8+ years of relevant experience working in the pharmaceutical industry (including CROs).
- 5+ years of relevant technical experience working within Clinical Operations or within Business Operations, including experience with clinical site and/or vendor contracts and budgets.
- Robust knowledge of site contracting and budgeting process U.S. and Rest of World
- Demonstrates ability to effectively lead, develop and manage the lifecycle of the site contracting process for assigned programs with minimum oversight.
- Ability to plan, prioritize, and organize work timelines, resources, and tasks to support timely execution.
- Excellent written and oral communication skills.
- Experience and confidence collaborating with multiple functional areas and facilitating communication across multiple levels of internal/external teams to drive solutions.
- Demonstrates commitment to business ethics.
- Demonstrates resilience to change; can find solutions in challenging environments.
- Effective problem-solving skills; full analysis; searches for hidden problems.
Nice to have:
- Overall understanding of clinical site payments process and region-specific nuances is a plus.
- Good understanding of clinical trial protocols, in particular those sections that may impact site contracts and budgets