Senior Clinical Site Budget Specialist

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.

About the role

The Senior Clinical Trial Budget Specialist 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 less experienced budget team members.

Responsibilities

• Guide and support clinical operations departments in the site budgeting process for ImmunityBio trials, as well as investigator-initiated trials, including 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 less-experienced members of the budget team.
• Perform ad-hoc and cross-functional projects as assigned to support business needs and provide developmental opportunities.

Requirements

• Bachelor’s degree with 7+ years’ progressive experience in budget and contract development.
• 4+ years’ experience in clinical research.
• Experience with contract negotiations preferred.
• Experience with domestic and international research studies preferred.

Skills

• 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.

Schedule

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

Pay

The annual base pay range for this position is $136,500 (entry-level qualifications) to $150,000 (highly experienced) annually. The specific rate will depend on the successful candidate’s qualifications, prior experience, as well as geographic location. This position is eligible for a discretionary bonus and equity award.

Benefits

• Medical, Dental, and Vision Plan Options.
• Health and Financial Wellness Programs.
• Employer Assistance Program (EAP).
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability.
• Healthcare and Dependent Care Flexible Spending Accounts.
• 401(k) Retirement Plan with Company Match.
• 529 Education Savings Program.
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance, and Employee Discounts, Rewards, and Perks.
• Paid Time Off (PTO) includes:
  • 11 Holidays.
  • Exempt Employees are eligible for Unlimited PTO.
  • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days, and 1 Cultural Day.