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 Responsible for overseeing and managing various aspects of operational activities within NACD. Takes ownership to deliver upon near & mid-term NACD goals, including those specifically aligned with the planning & successful delivery of studies within the clinical trial portfolio. Assists in creating, leading & delivering upon complex improvement/innovation projects for NACD and/or as part of a global team and as aligned to a business case, goals &/or future aspirations. Leads and supports the team 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 NACD & CMR and by efficiencies and optimization of organizational resource allocation. Relationships Reports into NACD Operations Director/Associate Director. Establish and manage relationships with external partners relevant to the design & implementation of clinical trials improvement/innovation projects for NACD & Novo Nordisk (e.g. Investigators and site staff, Health Systems, Contract Research Organizations and Site Management Organizations etc.) Establish and manage senior level relationships positively with multiple internal stakeholders relevant to the design & implementation of clinical trials improvement/innovation projects for NACD & Novo Nordisk (e.g., across NACD, CMR, International Operations (IO), HQ R&D, & Commercial). Supervisory responsibilities including both direct and indirect reports, as well as supporting contingent workers. Essential Functions
Planning and Strategy: Developing operational plans and strategies to achieve organizational goals, ensuring alignment with overall business objectives. Align on project strategy with Portfolio Director and TA heads
Resource Management: Managing resources such as personnel, equipment, and materials to ensure optimal utilization and allocation
Recruitment and Onboarding: Primarily responsible for recruitment and onboarding of operational roles, in partnership with Talent Acquisition and CMR Training
Performance Monitoring: Tracking key performance indicators (KPIs) to measure operational performance, identifying trends, and implementing corrective actions when necessary
Risk Management: Assessing and mitigating risks associated with operations, implementing measures to maintain a safe and secure work environment
Cross-Functional Collaboration: Working closely with other departments and teams to coordinate operational activities, facilitate communication, and foster a collaborative work culture, including direct partnership with the Portfolio Director(s)
Training and Development: Identifying training needs for operational staff, providing guidance, and facilitating professional development opportunities to enhance skills and knowledge
Budgeting and Cost Control: Plan operational budgets, monitor expenses, and implement cost-saving measures
Continuous Improvement: Encouraging a culture of continuous improvement, promoting innovation, and seeking ways to optimize operations through new technologies or practices
Stakeholder Management: Engaging with internal and external stakeholders, such as customers, suppliers, and partners, to build relationships, address concerns, and ensure effective and efficient operations
Physical Requirements
20% overnight travel required. May require occasional work outside of standard business hours to support special requests/events.
Development of People
Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
Qualifications
A Bachelor’s degree is required. An advanced degree preferred
A minimum of 9 years’ experience in the design, planning and conduct of GCP clinical trials; with at least 5 of those most recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/CRO) is required
Experience in managing/monitoring clinical research sites (in-house or on-site) prior onsite monitoring experience an added plus
Expert in ICH-GCP principles and the application of those principles to trial design, planning & conduct of clinical trials
In-depth knowledge & direct experience/interactions with the FDA (or equivalent regulatory authority) in relation to the design, planning & conduct of GCP clinical trials
Excellent communications skills (verbal, written, presentation) in English
Foundational skills in designing and implementing innovation/improvement initiatives, including the required change management
Strong analytical and problem-solving skills – adept at problem-solving and capable of addressing operational challenges and optimizing processes
A minimum of 5 years’ experience in coaching and developing others is required – shown ability to indirectly lead and direct teams
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.