Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Manager of Global Clinical Budget Development reports to the Associated Director and who works under limited supervision and guidance. This position serves as a subject matter expert in the clinical trial budget development space. Candidate will frequently interact interdepartmentally with R&D, Purchasing and Supply Management (PSM) and Finance business teams/functional areas including Study Forecasters/Financial Analysts, Legal, Clinical Payments, and Global Clinical Site Contracting teams for clinical study budget development. The Manager of Global Clinical Budget Development is also expected to identify and resolve issues that arise to ensure budgets are compliant with study protocol requirements, are aligned with overall study budget projections and consistent with the Fair Market Value (FMV) benchmarking tool (GrantPlan) pricing and thus reflecting the overall financial requirements to support AbbVie’s clinical trials.

Responsibilities:

• Provides operational expertise and strategic leadership, support, guidance, and training to teams on all aspects of global clinical budget development.
• Influences and efficiently partners with AbbVie R&D to build global clinical site study budgets in compliance with all applicable policies, procedures, and objectives.
• May assist in leading and managing the clinical budget analyst staff, including, but not limited to the workload management, quality of deliverables and escalation of issues to management when needed.
• Develop, maintain, and train stakeholders on the use of the global budget development documents, including the Exhibit A and other Fair Market Tool Assessments, Act as the first line of contact to stakeholder to provide strategic insight, when required, into budget building process with difficult protocol situations (i.e., complex clinical protocols, difficult therapeutic areas with high priority studies).
• Independently creates global and country specific clinical trial budget templates, FMV benchmarks, etc. using clinical budgeting tools and systems (i.e., GrantPlan, Conga, SharePoint etc.)
• Actively and effectively communicates status of budget build with key internal and external stakeholders in a timely manner. Communicates issues to stakeholders that could impact project timelines or other aspects for study start-up.
• Closely works with Clinical Development Operations (CDO) Study Project Manager (SPM), Study Management Associate (SMA), Project Lead (PL), Therapeutic Area Medical Director’s (TAMD), Legal, Outside United States (OUS), Contract Managers (CM), Payments, to mitigate, and resolve budget and/or FMV issues as they arise during any point in the clinical trial. Lead Clinical Study Agreement (CSA) Budget Strategy calls and present at Study Kick-off Meetings with cross-functional team members.
• Develops the most current and transparent budget that is also in-line with industry standards. Serve as a subject matter expert in medical/CPT code competencies across multiple therapeutic/functional areas.
• Applies United States Medicare Coverage Analysis (MCA) guidelines for applicable therapeutic areas and have a solid understanding of MCA requirements. Able to analyze budgets and identify cost drivers where applicable.
• Ability to review and analyze complex protocol amendments and decide budget impact and will work with SPMs, OUS, and CMs to be agile in determining the impact of the protocol and if the changes constitute in a budget amendment. Identify and participate in ongoing process improvement initiatives when appropriate (i.e., Budget Innovation Tool (BIT), new templates/processes etc.).

Qualifications

Minimum Qualifications:

• BA/BS is required
• Expertise with Excel is required.
• Minimum of 4 years of related job experience with 2 years of clinical budget experience

Preferred Qualifications:

• Science degree is preferred
• Clinical research experience is highly desirable.
• Expertise with clinical cost benchmarking tools and/or ICD-9/10 and CPT codes is highly preferred
• Clinical budget experience in a scientific setting is highly preferred.
• Customer support focused expertise is highly desirable.

Other Required Skills:

• Must have demonstrated ability in negotiation skills, project management skills and effective communication and relationship management abilities.
• Must have extreme attention to detail along with an understanding of the quality/compliance environment.
• Ability to sustain high levels of performance in a constantly changing environment.
• Proven experience in managing all levels of key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into process improvements as appropriate.
• Hybrid model 3 days/week onsite.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html