Address
Form of workAbout 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
Drive study management activities and manage cross-functional study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance. Proactively track, monitor and report trial risks, progress/performance, timelines, and financial metrics on an ongoing basis to study and program teams. In collaboration with internal and external partners, identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs and patient recruitment and retention strategies to deliver enrollment targets. Accountable for overall performance management of trial managers and CSLs, who contribute to the planning, conduct and reporting of clinical trials. Ensures business needs are met through alignment of business plans and operational need within the Therapy Area and in partnership with Operational Excellence & Delivery (OED) regarding efficiencies and optimization of organizational resource allocation. 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.
Relationships
Reports into North American Clinical Development (NACD) Therapy Area Head. 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 CDD, & Commercial).
Supervisory responsibilities including both direct and indirect reports, as well as supporting contingent workers.
Essential Functions
- Planning and Strategy: Develops and drives goal setting, prioritization, and operational implementation plan for their respective Therapy Area in partnership with OED; considers relevant input and guidance to other areas within NACD including Operations Director and TA Heads
- People Management: Provides daily people management individual contributors to ensure effective performance management, team collaboration, training and development, employee engagement, and recognition
- Change Management: Identifying areas for improvement in operational processes and implementing changes to enhance efficiency, productivity, and quality. Encouraging a culture of continuous improvement, promoting innovation, and seeking ways to optimize operations through new technologies or practices
- Finance & Resource Management: Track and forecast resource capacity in collaboration with OED, utilization, and allocation to optimize productivity and ensure alignment with TA Head. Collaborate with OED, CMR Strategic Operations, and Finance to develop and ensure alignment managing resources such as personnel, equipment, and materials to ensure optimal utilization and allocation, and operational budgets, monitoring expenses, and implementing cost-saving measures
- Performance Monitoring: Tracking key performance indicators (KPIs) to measure operational performance, identifying trends, and implementing corrective actions when necessary. Monitor and manage performance of external service providers, escalate issues where appropriate, and make the appropriate changes to ensure trial conduct is completed in compliance and meets Novo Nordisk’s business standards
- Risk Management: Assessing and mitigating risks associated with operations, implementing measures and staying current with regulations/practices/industry trends. Ensure staff is adequately trained in ICH, GCP, regulatory guidelines and internal processes/SOPs
- Cross-TA Collaboration: Responsible for implementation of best practices and standards for clinical operations, including sharing lessons learned. Partner closely with other departments and teams to coordinate operational activities, facilitate communication, and foster a collaborative work culture, including direct partnership with the Operations Director(s)
- Stakeholder Management: Build strong internal and external relationships with key stakeholders across CMR, NNI, NNCI, and HQ-CDD
Physical Requirements
10-20% overnight travel required.
Development of People
Supervisory, 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 required
- A minimum of 11 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting, of which 10 years must be directly related to clinical trial execution. At least 3 years must be within direct trial management
- A minimum of 3 years supervisory or 5 years of project team leadership experience required
- 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
- Excellent skills in designing and implementing innovation/improvement initiatives, including the required change management
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.
