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

The Senior Director, Innovative Trials leads the development and execution of specific RWD strategic initiatives and programs for the randomized real-world trials through internal and external customer engagement, communication, and advanced randomized evidence generation. The Senior Director leads the innovative trials working group, a cross-functional team focused on advancing the organizational use and adoption of innovative trials. This individual will also educate the organization on the value, use and design of innovative trials.

The Senior Director communicates the innovative real-world trials strategy and project execution to internal and external stakeholders in Novo Nordisk Inc., (NNI) and more broadly across NN as well as serves as an advisor on randomized real-world evidence methods. This individual will grow NN innovative trials expertise both within NN as well as externally within the broader scientific community.

Relationships

The Senior Director, Innovative Trials reports to the head of Clinical Development Strategy and Research (CDSR). The Senior Director is responsible for the functional area leadership within CDSR through proactive stakeholder engagement and associated randomized RWE execution, communication of innovative trials strategy and RWE to internal and external stakeholders, and leadership in the use of randomized designs to generate RWE.

Essential Functions

• The incumbent acts as a strategic partner and leads customer engagement in the development of innovative randomized trial designs with NNI stakeholders across Clinical Development and Outcomes Research as well as within Clinical, Medical and Regulatory more broadly to include North America Clinical Operations, Regulatory and other functions outside of CMR to include commercial functions such as Marketing, Market Access and Public Affairs. This individual will also work closely with global colleagues in Medical & Science, Epidemiology, Data Science and Real-World Evidence
• The role will lead the development and execution of innovative randomized trial designs in the development of real-world evidence
• Serves as the function area leader in the execution of specific in-house real world randomized pragmatic trials across the entire Novo Nordisk portfolio utilizing the Novo Nordisk data platform as well as working with external platforms housing real world data (including electronic health records, administrative health claims, as well as uniquely sourced health data)
• Leads and manages the execution of the innovative trial design functional area conducted internally, with partners and with vendors
• Develops and maintains stakeholder relationships to ensure optimal utility of innovative trials designs within the entire Novo Nordisk organization
• Mentors junior staff
• Communicates RWE from innovative trial designs to internal stakeholders, customers and scientific community
• Leadership in the implementation and further development of innovative trial designs including pragmatic trials and registry based randomized designs
• Acts as a key subject matter expert in methodological and advanced analytic functions related to innovative trial designs and provides consultation to / collaborates with key internal and external stakeholders directly to provide tangible solutions that are aligned to portfolio strategy

Physical Requirements

10-20% overnight travel required.

Qualifications

• Minimum of a Master’s degree in relevant field required (e.g., epidemiology, biostatistics, health services research, health economics); MD or PhD preferred
• Ideally 9 years-of experience in leading RWD analytics, development of RWE and key stakeholder engagement roles preferred
• Minimum 9 years of experience in research using innovative randomized real-world data and its applications in clinical and business decision making preferred
• Experience in innovative trial design analytics
• Demonstrated prior research accomplishment (e.g., publications in peer-reviewed journals and presentations at scientific conferences)
• Excellent leadership, strong communication and critical thinking skills with keen knowledge of real-world randomized designs
• Excellent process and project management skills
• Strong business acumen and a team player
• Strong strategic thinking skills

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.