Manager, Development Sciences Business Operations

Who We Are

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.

 

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 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 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, by managing the development, negotiation and execution of vendor and clinical site budgets and contracts and managing the financial and resource projections across clinical projects and trials.

Key Responsibilities of Business Operations include:

• Aligning with Global Clinical Development on the clinical trial strategy in order to successfully contribute to trial execution;

 

• Portfolio and program-level vendor selection and contracting strategy, including negotiation of scope and budget for proposed vendor services in line with clinical trial assumptions, program drivers and milestones;

• Quantitative analysis of vendor bids and proposals;

 

• Drafting and negotiating vendor and clinical site contract and budget documents;

 

• Liaising with clinical development teams regarding all aspects of financial strategy and management;

 

• Supporting vendor contract management and performance oversight.

About the Opportunity:

 

The Manager, Development Science 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 Business Operations Program Lead (BPL), the BPSM is responsible for managing the lifecycle of clinical trial site contracts and budgets from development to close-out. 

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.

 

• Responsible for the development of global site budget templates and leading budget negotiations directly with sites or managing outsourced negotiations through CRO/vendor.

 

• 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 and payment processes for assigned programs.

 

• Budget analysis and estimation. Review protocol synopses and draft protocols to understand procedures and schedule of patient assessments to identify key cost drivers. Leverage available bench marking tools and historical site cost data to derive estimated per patient cost estimates for study team planning

• Responsible for vendor oversight for outsourced site contracts/payments services

 

• Responsible for identifying, developing and implementing relevant process improvements.

 

• Act as the Business Operations SME on the study protocol regarding the schedule of events (SOE’s) and how sites will operationalize SOE tasks into a fair budget.

 

• 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.

 

• Liaise with cross-functional departments involved in, or impactful to, clinical contracts, budgets or payments.

 

• Stay abreast of current industry best practices for fair market value evaluation, budget build and negotiation, and site 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.

 

 

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

 

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.