Investigator Budgets Manager (Biotechnology)

SUMMARY / JOB PURPOSE :

The Investigator Budgets Manager is responsible for developing and negotiating budgets for clinical trials in accordance with protocol specifications. They conduct budget negotiations with sites, create and maintain tracking systems, and oversee Investigator Budgets (IB) Process Manager roles. Additionally, they may supervise and train staff, conduct Medicare coverage analyses, and assist in CRO relationship management.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Develop clinical trial budgets according to protocol specifications.
• Independently manage clinical trial budget negotiations with sites, including those conducted through Contract Research Organizations (CROs) within service-level agreements.
• Maintain a tracking system of all clinical study agreements, issues, and communications with internal and external sources regarding contract and budget status.
• Responsible for directly interacting with USA and CAN sites and CROs in executing ongoing clinical trial budget negotiation reviews.
• Review and negotiate investigator-prepared budgets for FMV compliance.
• Develop management reports to support budgeting and forecasting.
• Contribute to the design, format, and content of CRO and site budget guides and template instructions.
• Prepare presentations for Investigator and vendor meetings related to budgets and site payments.
• Has internal contact with relevant departments such as Drug Safety, Clinical Operations, Legal, Medical Affairs Operations, and others as necessary.
• Participate in clinical study team meetings.
• Perform Medicare coverage analyses and may train staff or other depts.
• Coordinate CRO relationships and manage performance.
• Help foster good relationships with clinical investigators.
• Ensure compliance with Exelixis' policies and procedures.
• May hold the role of Investigator Budgets (IB) Process Manager for Investigator-Sponsored Trials (ISTs) FMV negotiations, EXEL-Sponsored Trials (ESTs) escalations and quality control (QC), Contract amendments, Data team, etc., and is responsible for the developing work instructions, internal and external training, managing workload and preparing and monitoring tracking systems.
• With the appropriate competency and skills, may supervise staff, assign work, and perform performance appraisals.

SUPERVISORY RESPONSIBILITIES :

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

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Experience / The Ideal for Successful Entry into Job :

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JOB COMPLEXITY :

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EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS :

LIVES THE EXELIXIS CORE VALUES DAILY :

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#LI-JD1!

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $124,500 - $177,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.