Senior Clinical Site Budget Specialist

About this role

Company Overview ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.

Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. • Work with a collaborative team with the ability to work across different areas of the company. • Ability to join a growing company with professional development opportunities.

Position Summary The Senior Clinical Trial Budget Specialist position will develop, deploy and administer standardized approaches to suppliers, contracts, and budgets for clinical trial operations.  The role will build clinical trial budgets for negotiation as well as provide budget and administrative policy guidance to the clinical operations departments.  The senior Clinical Trial Budget Specialist may mentor, coach and train lesser experienced budget team members.

Essential Functions • Guide and support clinical operations departments in the site budgeting process for ImmunityBio trials, as well as investigator initiated trialsincluding the preparation, negotiation and execution of clinical trial budgets, service contracts and agreements

• Identify opportunities for improvement to the clinical trial business process and recommend and draft Standard Operating Procedures (SOPs) and templates

• Monitor budget timelines, provide regular updates to trial stakeholders, and recommend tactics to achieve clinical program milestones

• Provide reports/analysis of trends in negotiation of budgets/agreements to management

• Triage incoming protocols for coverage analysis and budget build

• Perform detailed coverage analysis for clinical trials based on Center for Medicare and Medicaid Services (CMS) Policy, National Coverage Determinations (NCDs), Local Coverage Determination (LCDs), Drug Compendia, etc.

• Develop, review, and negotiate clinical trial budgets

• Partner and communicate with Legal, Finance/Accounting, and Clinical Operations Teams.

• Develop and maintain study-specific site budget templates and negotiate parameters for the budgets and contracts.

• Assist in budget, forecasting, auditing, and variance management activities

• Respond to coverage analysis, billing compliance, and budget-related questions

• Act as subject matter expert to select the best method to address billing compliance issues and negotiate budgets

• Educate others on the processes for budgets and billing compliance as needed

• Provide mentoring, coaching, and training to lesser-experienced members of the budget team

• Performs ad-hoc and cross-functional projects as assigned to support business needs and provide developmental opportunities.

Education & Experience • Bachelor’s degree with 7+ years’ progressive experience in budget and contract development required

• 4+ years’ experience in clinical research required

• Experience with contract negotiations preferred

• Experience with domestic and international research studies preferred

Knowledge, Skills, & Abilities • Knowledge and expertise in the use of Clinical Trial Management Systems and excel for budget development and negotiation

• Advanced skills in Excel

• Knowledge in coverage analysis and CPT coding

• Sound judgment, problem solving, matrix management, and collaboration in selecting methods and techniques for obtaining solutions to problems.

• Knowledge of the drug development process and cross-functional responsibilities

• Ability to influence various teams without direct reporting structure

• Extremely flexible, highly organized, and able to balance and quickly shift priorities

• Excellent project and process management skills with a track record of accomplishing tasks and delivering results

• Excellent interpersonal and communication skills, strong customer-service orientation, and the ability to work effectively with all levels of the organization and with a wide range of clients, individually and in groups

• Ambitious and driven with a keen interest in improving processes and development, both as a team and personally

• Understands supplier management and billing/regulatory compliance guidelines.

• Proven ability to handle extremely confidential information

• Experience using Veeva CTMS and payments

Working Environment / Physical Environment • This position works on either onsite in El Segundo, CA or Torrey Pines, CA

• Regular work schedule is Monday – Friday, within standard business hours.  Flexibility is available with manager approval.

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

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