Strategic R&D Business Operations Manager

Bio Marin 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. Bio Marin will continue to focus on advancing therapies that are the first or best of their kind.

The Manager, Strategic Research and Development Business Operations, holds a key support position within Business Operations acting as the Business Programs Site Manager (BPSM) for assigned programs. Under the leadership of the Site Contracts Functional Lead, the BPSM is responsible for managing the lifecycle of clinical trial site contracts and budgets from development to close‑out. The Strategic R&D Business Operations (Business Operations) group is the centre of excellence for providing industry best practice operational support for the conduct of Bio Marin’s global clinical trials, including clinical vendor and site contract management, strategic vendor oversight, and clinical financial spend analysis and management.

The group utilizes rigorous processes, procedures, and tools to ensure financial discipline and transparency in clinical vendor and trial site spend.

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.

• 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 benchmarking 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 close‑out 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…