Senior Director, Investigator Budgets

Role Summary

Provides strategic direction on all operational aspects of investigator budget management. Develops and oversees the execution of global site budget plans for timely study startup for Investigator-sponsored and EXEL-sponsored protocols. Develops and manages data/analytics and quality control teams for all clinical trial budgets. Develops and oversees the subject injury claim (SIC) process at Exelixis. Establishes departmental processes and ensures adherence to Exelixis's standards, and all applicable regulations and guidelines. Manages staff and provides assessment of training needs based on role description and project needs.

Responsibilities

• Manages investigator budgets and payments for Clinical Operations according to protocol specifications.
• Analyzes and negotiates investigator budgets for Medical Affairs according to protocol specifications.
• Manages SIC process and committee reviews.
• Develops written and efficient departmental processes that comply with applicable regulatory requirements.
• Oversees CRO’s budget negotiations between site personnel and company investigators for global and late phase studies.
• Develops and enhances relationships with clinical investigators, internal stakeholders, and vendors.
• Collaborate directly with Exelixis vendors to improve vendor services and/or software to facilitate trial execution.
• Develops management reports and metrics.
• Ensures that Investigator grants are compliant with Corporate Compliance.
• Manages input and reporting to the Clinical Trials Management System (CTMS) for CT budgets.
• Reviews and approves budget templates to be sent to sites for negotiations according to study protocol.
• Reviews and approves clinical outsourcing specifications for RFPs dealing with site budgets.
• Ensures adherence to Exelixis's SOPs, policies and all applicable regulations and guidelines.
• Sets departmental strategy for resourcing and departmental goals.
• Participates in or leads change initiatives including process improvement efforts.
• Stays abreast of latest developments in site budget management to ensure site budget negotiations are fair and allow for timely site activation.
• Promotes and communicates the role of the Clinical Operations department.

Qualifications

• Typically requires a minimum of 16 years of related experience and at least 8 years of management and 5 years of dept management experience.
• Demonstrated leadership, especially in complex matrix run organizations.
• Has extensive experience in site budget negotiations including best in class processes.
• Develops technical and/or business solutions to complex problems.
• Expert knowledge of GCP, Medicare, medical service billing/coding, and FCPA regulations related to the conduct of clinical trials worldwide.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Guides the successful completion of major programs, projects and/or functions.
• Leads or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Determines organizational or team objectives and interprets company policies.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.
• Applies strong analytical and business communication skills.

Skills

• Demonstrated leadership in complex matrix organizations.
• Strong analytical and business communication skills.
• Ability to develop technical and/or business solutions to complex problems.
• Experience guiding cross-functional teams in clinical operations or budget management.

Education

• BS/BA degree in Science, Business, or related discipline and a minimum of 15 years of related experience; or
• MS/MA degree in Science, Business, or related discipline and a minimum of 13 years of related experience; or
• PhD in Science, Business, or related discipline and a minimum of 12 years of related experience; or
• Equivalent combination of education and experience.
• May require certification in assigned area.