Senior Investigator Budgets Analyst (Biotechnology)

SUMMARY/JOB PURPOSE:

Performs clinical trial budget negotiation, analysis, and administration; assists in clinical trial budget template development; and QC reviews.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Assist in developing investigator grant budgets according to protocol specifications.
• Negotiate clinical study budgets with investigators or designated site personnel, typically through a CRO adhering to published service levels.
• Review and negotiate investigator-prepared budgets for FMV compliance, with Medical Affairs/IB Manager oversight adhering to published service levels.
• Contribute to timely updates to tracking systems for progress developed for all clinical site and Investigator-Sponsored Trials (ISTs) budgets, issues, and communications with internal and external sources.
• Participate in clinical working group meetings.
• Assist in coordinating IB management meetings, prepare agendas, draft, and finalize minutes, and track action items to completion.
• Assist in the development of management reports to support budgeting and forecasting.
• Perform Medicare coverage analyses.
• Perform final budget quality check (QC) in accordance with established SOPs.
• Assists with various other business needs and projects as required to support the organization.

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and a minimum of five years of related experience; or,
• MS/MA degree in related discipline and a minimum of three years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

• Experience in developing and/or negotiating clinical trial research budgets and payment terms
• Experience with administration of site budgets and grants, including independent preparation of clinical trial budgets and/or site payment management
• Experience with performing clinical trial research budgets and payment terms quality check
• Experience in research protocol budget analyses
• Experience in Medicare Coverage Analyses (MCA)
• Experience in interactions with outside vendors, e.g., CROs and contract labs
• Strong Excel knowledge required
• Proficiency in MS Office required and Smartsheet preferred
• Prior experience in Biotech/Pharmaceutical industry preferred
• Oncology company experience preferred

Knowledge/Skills:

• Ability to perform thorough reviews of budget documents in MS Excel quickly and without errors.
• Performs various complicated tasks with a wide degree of creativity and latitude.
• Determines methods and procedures for new assignments.
• Has wide-ranging experience in area of specialization.
• Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Has a complete understanding and wide application of technical principles, theories, concepts, and techniques.
• Knowledge of the clinical development process and associated regulations (e.g., FDA, CMS, FCPA, etc.)
• Has good general knowledge of other related disciplines.
• Applies strong analytical and business communication skills.
• Ability to successfully collaborate with multiple stakeholders and execute clinical trial contracts according to company timelines.
• Ability to problem-solve.

JOB COMPLEXITY:

• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results.
• Networks with key contacts outside own area of expertise.
   

DESIRED BEHAVIORS:

• Ability to study, analyze and understand new situations and business problems and identify appropriate solutions
• Operationally excellent and drives others towards excellence
• Resilient in the context of a rapidly changing environment
• Organized with a systematic approach to prioritization

EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS:

• We drive for results, so patients can survive and thrive.
• We are resilient in the face of adversity and tireless in advancing our science.
• We celebrate our long history of prolific drug discovery and rigorous drug development.
• We unite to launch innovative medicines for difficult-to-