Senior Director, Development Sciences Business Operations

OVERVIEW:

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 documents;
• Liaising with clinical development teams regarding all aspects of financial strategy and management;
• Supporting vendor contract management and performance oversight.

This role will contribute to the overall clinical portfolio business operational activities across Business Operations in collaboration with Legal, Financial Planning & Analysis, Global Strategic Sourcing (GSS) and Global Clinical Development key stakeholders to optimize clinical trial spend and empower Clinical Development Teams and Study Execution Teams regarding vendor and site-related decisions without sacrificing quality, timelines or performance.  The Senior Director, Business Operations will participate in one or more compound-focused program teams in support of BioMarin’s global clinical trial execution.

KEY RESPONSIBILITIES:

Contracting and Oversight

• Provide critical support to Business Operations team members, as well as other key stakeholders, to ensure timely and efficient drafting and negotiation of clinical trial agreements and associated vendor scopes of work within the guidelines established in collaboration with Legal, including communications with these third parties.
• Support and provide input into the vendor and clinical trial site contracting strategy across programs.
• Collaborate with GSS around strategic outsourcing and vendor selection activities.
• Partner with GSS and the Study Execution Teams in the review of vendor proposals, including the qualitative analysis and comparison of vendor proposals and budgets in competitive bidding.
• Lead the quarterly Business Operations/Legal joint meeting and drive improvements in the contracting and oversight activities for which Business Operations is responsible, including providing input on the operational consequences of business terms within master services agreements.
• Proactively investigates and resolves complex contracting and budgeting issues.

Financial Management

• Partner with Study Execution Teams to establish key assumptions required for the development of clinical study budgets and support the review and management, including both clinical site costs and external trial costs.
• Partner with Study Execution, Clinical Develop Teams and the Finance, Procurement & Accounting Teams to provide guidance on financial and operational consequences of study design decisions, including cost savings and/or cost increases resulting from changes in outsourcing strategy, contracting, and/or clinical trial assumptions.
• Support key stakeholders in vendor contract financial management, including aligning vendors with BioMarin processes.
• Support financial transparency and accountability in vendor and clinical trial site contracting.

General Responsibilities

• Ensure timely execution of clinical site agreements and vendor scopes of work by supporting systems, processes and structures that support achievement of aggressive operational and scientific goals.
• Identify and drive implementation of opportunities for building efficiencies into the clinical trial agreement and vendor scope of work contracting processes.
• Partner with the Study Execution Teams, Clinical Development Teams, functional area SMEs, and Business Operations colleagues to understand the financial and operational impact of identified changes to trial scope, supplier scope, budgets and forecasts.

EDUCATION & EXPERIENCE  

• BA/BS in health sciences, legal studies or related degree. Advanced degree or Juris Doctorate preferred.  Experience in lieu of education may be considered.
• 12+ years of relevant experience working in the pharmaceutical industry (both industry and CRO experience preferred), including a minimum of 5 years of relevant technical experience with negotiating clinical site and/or vendor contracts and budgets.
• Robust knowledge of applicable law and guidance (e.g., GCP guidelines, OIG Fraud and Abuse laws, Sarbanes-Oxley Act, General Data Protection Regulation, PhRMA code guidelines) and their impact on each stage of the trial from start-up through close-out.
• 6+ years of people management experience, including successful management of senior level performers.
• 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 and ensuring that colleagues understand and adhere to core business values.
  • Demonstrates ability to effectively lead, develop and manage high performing teams.
  • Demonstrates resilience to change; can find solutions in challenging environments.
  • Appropriately delegates tasks; shares responsibility and accountability.
  • Effective problem-solving skills; full analysis; searches for hidden problems.