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Senior Manager, Development Sciences Business Operations

Location San Rafael, California

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

Key responsibilities of Business Operations include: 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 contract strategy and management; contributing to vendor performance oversight; and developing and managing clinical trial forecasts and budgets in partnership with key stakeholders.

SUMMARY DESCRIPTION:

The Sr. Manager, Business Operations, holds a key support position within Business Operations. Under the leadership of the Business Operations Program Lead, the compound-focused Business Operations teams are responsible for the following deliverables for their clinical development program: contract and budget development, negotiation and management for both vendors and sites; vendor oversight; and financial oversight.

The Sr. Manager, Business Operations, will contribute to the overall clinical portfolio business operationalactivitiesacross Business Operations in collaboration with Global Strategic Sourcing and Clinical Operations to optimize clinical trial spend and empower Study Execution Teamsregarding vendor-related decisions without sacrificing quality, timelines or performance. The Sr. Manager, Business Operations will participate in one or more compound-focused program teams in support of BioMarin’s clinical trial execution.

KEY RESPONSIBILITIES:

Clinical Site Contracting

  • Contribute to the successful collaboration of Business Operations with key stakeholders (e.g.: Study Execution Teams, Global Project Management and GSS) to collect key assumptions required for the development of clinical trial contracts and associated budgets.
  • Draft and negotiate clinical site budgets and contracts, including direct communication with sites and/or managing vendors where these activities are outsourced to a third party (e.g., contracts with sites outside of the US).
  • Partner closely with BioMarin’s Legal Department in the drafting and negotiation of site contracts.

VendorContracting and Oversight

  • Understand and assist in driving 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.
  • Negotiate vendor scopes of work and budgets, including communications with vendors and drafting of final contracts.
  • Support vendor selection on behalf of the Study Execution Teams for any vendors not directly supported by GSS, including DSMB, Steering Committees, and Regulatory vendors.
  • Support Study Execution Teams in the management and oversight of clinical study vendors.

Financial Management

  • Partner with others on the Business Operations team in the use of the BOARD platform to improve financial management and forecasting of study costs, including for purposes ofcontractmanagementand vendor oversight.
  • Support financial transparency and accountability in vendor and clinical trial site contracting.
  • Understand 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.
  • 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.

General Responsibilities

  • Ensuretimelycontract execution by supporting systems, processes and structures that support achievement of aggressive operational and scientific goals.
  • Collaborate with Compliance and Development Sciences Quality to ensure coordination of vendor audits and relevant follow up activities. Ensure proper documentation, archiving and inspection-readiness of all Business Operations managed contracts.
  • Identify opportunities for building efficiencies into the process of clinical contracting.

KEY COMPETENCIES:

TheSr. Manager, 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 Sr. Manager, Business Operations must also demonstrate a level of mastery in multipletechnical competency areas, including:

  • contributing to cross-functional decisions regarding financial impact of  contracting;
  • understanding big picture implications and considerations of drug development strategies;
  • providing 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.
  • 5-8 years of relevant experience working in the pharmaceutical industry (including CROs)
  • 2-5 years of relevant technical experience working within Clinical Operations or within Business Operations, including experience with clinical site and/or vendor contracts and budgets

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San Rafael

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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