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Manager - Trial Budgeting & Outsourcing

Employer: Novo Nordisk
Location: Plainsboro, NJ
Start date: Nov 12, 2024

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Discipline: Administration, Accounting, Finance, Clinical, Science/R&D, Biotechnology
Required Education: Bachelors Degree
Position Type: Full time
Hotbed: Pharm Country, Best Places to Work

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Job Details
Company

Job Details

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.

Company

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

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