Manager - Trial Budgeting & Outsourcing

About the Department                                                                                                                                               

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

The Position

This position is responsible for the financial management and oversight of internal and external strategic collaborations to optimize alliance performance by building relationships, developing and maintaining strong communication channels.

This position is accountable for the financial management and budget development of North America Clinical Operations (NACO). Responsible for driving financial oversight across trial portfolios to ensure adherence to the trial strategy and execution to targets. Co-leads communication to global and local stakeholders to ensure consistency. Proactively identifies financial opportunities or risks and partners with stakeholders to plan and execute on mitigations or opportunities. Leads third-party negotiations with suppliers and is responsible for tracking and management of performance and contract financials. Responsible for financial reporting, analytics, and submission of key financial deliverables including anchor budget (AB), month end, and rolling estimates (REs). Develops operational financial modeling and scenario analyses.

Relationships

Reports to the head of Trial Budgeting and Outsourcing. This position requires strong collaboration with stakeholders across Clinical Medical and Regulatory (CMR), including the NACO senior leadership team and line of business management team, as well as the broader North America Clinical, Medical and Regulatory (CMR) function and global stakeholders in Global Development (GD) and Research and Development (R&D), locally with Procurement and Legal.

Essential Functions

• Leads the coordination and preparation of RE/AB budget support and documentation from draft protocol through trial closure for North America Clinical Operations (NACO)
• Manages and communicates financial status of ongoing clinical trials, including identification of variance and risks. Identifies opportunities and potential mitigations and develops new forecasts as required
• Ensures that clinical trial budgets remain on track and aligned with global planning estimates.  Continuously monitors and reports on status and expected outcomes
• Ensures all clinical trial-related SAP transactions are posted appropriately
• Oversees payments to clinical trial investigators through third party supplier
• Drives the creation of trial -level financial strategies across the portfolio in collaboration with Trial Management
• Collaborates effectively with global and local stakeholders, including but not limited to Procurement, Finance, Legal, Global Development and R&D Finance
• Accountable for all aspects of vendor management for assigned trials, effectively negotiates third party clinical contracts in adherence to Fair Market Value and internal policies
• Directly negotiates contracts with suppliers in accordance with established policies, regarding SOWs, processing invoices and change orders
• Participates in cross-functional teams locally/globally to assure timely attainment of project milestones
• Develops solutions for process improvements; enhance quality and budget accuracy via financial modeling and automation
• Responsible for creating, compiling, analyzing, and reporting all required financial forecasting and analysis as part of the RE and annual budget submission
• Responsible for the portfolio guidance to SAM staff with respects to site contracting, FMV adherence, site payments, ancillary and printing supplies
• Ensures financial transparency between R&D Finance and clinical operations while maintaining data consistency and accuracy across financial and operational systems
• Proactively manages financial risks though root cause analysis and coordination of cross functional teams to implement corrective and preventive action plans

Physical Requirements

0-10% overnight travel required.

Qualifications

• A Bachelor’s degree is required
• Advanced degree is preferred
• 7 years of relevant accounting/financial experience, including at least 3 years relevant experience with a pharmaceutical, biotechnology, CRO and/or healthcare setting required
• Foundational skills in designing and implementing innovation/improvement initiatives, including the required change management
• Advanced knowledge of MS office
• Demonstrated strong communication (verbal, written, presentation) and stakeholder management skills
• Demonstrated core understanding of clinical operations and budgeting with respects to trial start up through trial closure
• Ensures contract compliance in accordance with established policies
• Ability to think strategically and initiate strong and persuasive contractual arguments to support business policies and objectives
• Demonstrated analytical skills and critical thinking to resolve issues in a variety of complex situations requiring new solutions
• Ability to influence, lead and effectively interface within a matrixed environment and with varying professional levels
• Demonstrated commitment to quality, attention to detail and providing the highest quality services to internal and external stakeholders
• Demonstrated competencies in the technical, regulatory, and legal terminology of contracts, preferably in clinical trials
• Must work with minimal direction. Ability to plan, schedule, and arrange activities in accomplishing objectives

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.