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 Food & Drug Administration (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?
1 of 2 Positions
Provides strategic & tactical leadership to staff, including line/business managers, within the Operational Strategy and Planning (OS&P) function of North America Clinical Operations (NACO). Provides input and takes ownership to deliver upon near & mid-term NACO goals, including those specifically aligned with the planning & successful delivery of studies within the clinical trial portfolio.
Reports to head of Operational Strategy and Planning function within NACO. Establishes & manages mutually beneficial relationships with external partners relevant to the design & implementation of clinical trials improvement/innovation projects for NACO & Novo Nordisk (e.g. Health Systems, Contract Research Organizations, Clinical Vendors and Site Management Organizations etc.). Establishes & manages senior level relationships positively with multiple internal stakeholders relevant to the design & implementation of clinical trials improvement/innovation projects for NACO & Novo Nordisk (e.g., across NACO, Clinical Medical Regulatory (CMR), International Operations (IO), Headquarter (HQ) R&D, & Commercial). Supervisory responsibilities within OS&P, including both direct & indirect reports.
- Identifies, creates & leads complex improvement/innovation projects for NACO and/or as part of a global team and as aligned to a business case, goals &/or future aspirations
- Provides leadership in complex and continually changing CMR and Global environment, via a future focused approach, leveraging competencies, tools and technology, and with change management skills
- Ensures business needs are met through alignment of business plans and operational need across OS&PSM and NACO and by efficiencies and optimization of organizational resource allocation
- Accountability for quality and performance related to managing strategy, planning, training, communication and governance across NACO portfolio clinical trial sites, document handling and trial product handling
- Ensures alignment & support is in place to design, plan & deliver all relevant services/tasks in support of the design, planning & quality delivery of clinical trials
- Develops & oversees relevant contracts & budgets – including compiling, forecasting, tracking & revising
- Formulates & drives the objective setting, prioritization & tracking within OS&P for direct/indirect reports; considers relevant input and guidance to other functional areas within NACO
- Works with Senior Leadership team to prepare, develop and execute clinical development strategy
- Oversees training & development of staff as required across NACO by assuring training plans (NACO level & project level) are developed & deployed at the functional level & for direct/indirect reports
- Ensures that all personnel within function understand the priorities of the business, that they are focused on those priorities and that their level of accountability is understood and accepted
- Demonstrates technical expertise within functional responsibility area, staying up-to-date of new approaches & practices and building knowledge of emerging trends and advances within area
- Contribute to local and global team initiatives
10-20% overnight travel required. May require occasional work outside of standard business hours to support special requests/events.
- A Bachelor’s degree is required (in science-related discipline preferred)
- A minimum of 12 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting, of which 10 years must be directed related to clinical trial execution. The last 5 years must be within a leadership or senior management position with supervisory requirement associated within a function of clinical trial execution
- Expert in International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) principles and the application of those principles to trial design, planning & conduct of clinical trials
- Excellent communications skills (verbal, written, presentation) in English
- Strong analytical, negotiation, meeting management, cross-functional team and leadership skills required as demonstrated from international representation at a senior management level
- Expert in ICH-GCP principles and the application of those principles to trial design, planning & conduct of clinical trials
Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
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.