Manager/Sr. Manager, Development Sciences Business Operations

Location:  San Rafael, California Category: Clinical

Description

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, vendor contract management and clinical site budgets.  The group utilizes rigorous processes, procedures, and tools to ensure financial discipline and transparency in vendor and site spend, assists with financial and resource projections across clinical projects and studies, manages the development, negotiation and execution of clinical site budgets and vendor 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, including negotiation 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 contract documents; liaising with study 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 Manager/Sr. Manager, Business Operations, holds a key support position within Business OperationsUnder the leadership of the Business Operations Program Lead, the program-focused Business Operations teams are responsible for the following deliverables for their clinical development program: contracts management; vendor oversight; clinical site budgets; and financial oversight. 

The Manager/Sr. Manager, Business Operations, will 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-related decisions without sacrificing quality, timelines or performanceThe Manager/Sr. Manager, Business Operations will participate in one or more Program Teams in support of BioMarin’s clinical trial execution. 

KEY RESPONSIBILITIES:

Vendor Contracting 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 proposals and budgets, including communications with vendors.

          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.

          Ensure timely clinical vendor contract execution by supporting implementation of system, processes and structure that support achievement of aggressive operational and scientific goals.

          Draft and negotiate vendor contracts and budgets. 

          Partner with the Study Execution Teams, functional areas SMEs, and Business Operations colleagues to understand the impact of identified changes to study scope, supplier scope, budgets and forecasts.  Work with Finance on any accruals and forecast updates associated with such changes.

          Support contract and financial approvals process in accordance with BioMarin policies.

          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 vendor selection projects and contracts.

          Identify opportunities for building efficiencies into the process of clinical vendor contracting.

 

Financial Management

          Partner with others on the Business Operations team in the implementation of the BOARD platform to improve financial management and forecasting of study costs for vendor contract management and vendor oversight.

          Support financial transparency and accountability in vendor contracting.

          Understand savings and/or cost increases resulting from changes in outsourcing strategy, contracting, and/or clinical assumptions.

          Contribute to the successful collaboration of Business Operations with Key Stakeholders (e.g.: Study Execution Teams, Global Project Management and Global Strategic Sourcing) to collect key assumptions required for the development of clinical study contracts and associated budgets

          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.

 

KEY COMPETENCIES:

The Manager/Sr. Manager, Business Operations is expected to demonstrate mastery across a range of Business Operations core competencies, including:

          building, motivating and empowering high-performing teams, including conflict resolution;

          demonstrating commitment to business ethics and ensuring that teams 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;

          inspiring and motivating others;

          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 continuous improvement;

          being recognized as a subject matter expert and persuasively presenting positions and solutions;

          communicating complex concepts and results clearly and comfortably to Business Operations leadership; and

          modeling and encouraging a culture of proactivity and self-improvement.

 

The Manager/Sr. Manager, Business Operations must also demonstrate a level of mastery in multiple technical competency areas, including:

          contributing to cross-functional decisions regarding financial impact of vendor contracting;

          understanding big picture implications and considerations of drug development strategies;

          providing input into weighing vendor preferences due to study/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 clinical project/study 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