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Associate Director, Development Sciences Business Operations

Location San Rafael, California

Associate 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 strategic vendor oversight, clinical financial spend analysis and management, and clinical vendor and site contract management. The group utilizes rigorous processes, procedures, and tools to ensure financial discipline and transparency in vendor and clinical trial site spend, assists with financial and resource projections across clinical projects and trials, manages the development, negotiation and execution of vendor and clinical site budgets and contracts, as well as facilitates effective clinical vendor oversight.

Key responsibilities of Business Operations include: developing and managing clinical trial forecasts and budgets in partnership with key stakeholders; aligning with Clinical Operations and Clinical Sciences on understanding clinical trial strategy in order to successfully contribute to trial execution; portfolio- and/or program-level vendor selection and contracting strategy, includingnegotiation of scope and budget for proposed vendor services in line with clinical trial assumptions, drivers and milestones; quantitative analysis of vendor bids and proposals; drafting and negotiating vendor and clinical site contract documents; liaising with trial execution teams regarding all aspects of financial strategy and management; and contributing to vendor performance oversight.

SUMMARY DESCRIPTION:

The Associate Director, Business Operations, holds a key position within Business Operations. Under the leadership of the Executive Director, Business Operations, this role will lead the team in the development and management of clinical trial forecasts, budget and long-range plan, as well as clinical program cost modeling.  The Associate Director, Business Operations will also contribute to the overall clinical portfolio business operational activities across Business Operations in collaboration with Global Strategic Sourcing and Clinical Operations to optimize clinical trial spend and empower Study Execution Teams regarding vendor and site-related decisions without sacrificing quality, timelines or performance. The Associate Director, Business Operations will participate in one or more compound-focused program teams in support of BioMarin’s clinical trial execution.

KEY RESPONSIBILITIES:

Financial Management

  • Responsible for the overseeing the financial planning and budgeting of all new studies, including the development of scenario analyses based on outsourcing strategy and clinical trial strategy and assumptions.
  • Lead alignment effort between Corporate Finance and various functions within Global CIinical Developmentregarding processes for variance analyses, forecasting and long-range planning of clinical studies.
  • Responsible for management of clinical study financial management platform (BOARD), including internal stakeholder training for the routine study planning, simulation, budgeting and change order planning.
  • Directly lead and supervise staff developing clinical study variance analyses, forecasting and budgeting models.
  • Drive cross-departmental process improvement initiatives relating to clinical trial spend, such as improving financial reporting of vendor spend, generating and analyzing value earned analyses, developing vendor financial metrics, aligning processes for the PO assignment and GL reporting, and improving communication with key stakeholders and Global Clinical Development senior management.
  • Supporting Global Clinical Development senior management in analyzing program and trial variances, includingguiding discussions relating to trade-off decisions, identifying program savings opportunities and anticipating financial and strategic impact of outsourcing strategy, timing and clinical trial assumption changes.
  • Lead the development of scenario financial planning for existing and potential clinical development programs based on corporate drivers and clinical study assumptions.
  • Partner with Study Execution Teams to establish key assumptions required for the development of clinical study budgets.  Provide ongoing support to Study Execution Teams in the review and management of clinical study budgets, including both investigator grants and external trial costs.
  • Provide critical support to internal Business Operations team members, as well as other key stakeholders in the review and analysis of program and clinical study forecasting and variance analyses.
  • Support Key Stakeholders in vendor contract financial management, including adherence to applicable leading financial review activities with key vendors and aligning vendors with BioMarin processes.
  • Support the clinical study vendor selection process, with focus on CRO spend management, including budget development and improvement, quantitative bid analyses, historical price analyses and budget negotiations.
  • Partner with others on the Business Operations team in the use of the BOARD platform to improve financial management and forecasting of study costs.
  • Support financial transparency and accountability in vendor and clinical trial site contracting.
  • Drive discussions relating to cost savings and/or cost increases resulting from changes in outsourcing strategy, contracting, and/or clinical trial assumptions.
  • Support the financial oversight of clinical vendors, including advising key stakeholders of trends and potential financial risks, as well as reviewing financial information for quarterly Executive Oversight Meetings.

Vendor Contracting and Oversight

  • Support the vendor contracting strategy within assigned programs and provide input for the same at the portfolio level.
  • Collaborate with Global Strategic Sourcing (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.
  • Support the drafting and negotiation of vendor scopes of work and budgets, including communications with vendors and drafting of final contracts.

General Responsibilities

  • Ensure timely delivery of clinical trial forecasts and budgets by supporting systems, processes and structures that support achievement of aggressive operational and scientific goals.
  • Partner with the Study Execution Teams, functional areas SMEs, and Business Operations colleagues to understand the impact of identified changes to trial scope, supplier scope, budgets and forecasts. Work with Finance on any accruals and forecast updates associated with such changes.
  • Identify opportunities for building efficiencies into the process of clinical trial financial management.

KEY COMPETENCIES:

TheAssociate Director, Business Operations is expected to demonstrate mastery across a range of Business Operations core competencies, including:

  • building, inspiring, motivating and empowering high-performing teams, including conflict resolution;
  • demonstrating commitment to business ethics and ensuring that colleagues understand and adhere to core business values;
  • ability to plan, prioritize, and organize work timelines, resources, and tasks to support timely execution;
  • using rigorous logic to address challenges;
  • leveraging knowledge of the organization to support decision-making and resolution of complex issues;
  • driving for results in self and others, including a commitment to model proactivity and continuous improvement;
  • being recognized as a subject matter expert and persuasively presenting positions and solutions; and
  • communicating complex concepts and results clearly and comfortably to Business Operations leadership.

The Associate Director, Business Operations must also demonstrate a level of mastery in multipletechnical competency areas, including:

  • driving cross-functional decisions regarding financial impact of contracting;
  • understanding big picture implications and considerations of drug development strategies;
  • providing significant input into weighing vendor preferences due to trial/project synergies, executive preference, etc. with the preferences of a particular team to optimize BioMarin’s financial and operational performance;
  • contributing to an organization-wide view on how financial and accounting decisions are made and the impact on corporate finance, reporting, and executive decision-making;
  • embracing a culture that values the importance of process, technology, and performance measurement to drive improvement;
  • demonstrating robust knowledge of GCP guidelines and their impact on each stage of the trial (start-up through close-out) and actively contributing to discussions with vendors and project team on GCP compliance issues;
  • contributing to scenario analyses and identifying financial implications of project and vendor decisions;
  • understanding global competitive environment for executing a clinical project/trial in a therapeutic area; and
  • proactively investigating and resolving complex contracting and budgeting issues.

EDUCATION AND EXPERIENCE:

  • BA/BS in finance, accounting, health sciences, or related degree. Advanced degree preferred. Experience in lieu of education is considered.
  • 8-10 years of relevant experience working in the pharmaceutical industry (including CROs).
  • 5-7 years of relevant technical experience working within Clinical Operations or within Business Operations, including experience with clinical site and/or vendor contracts and budgets.
  • People management.

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