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Director - NACD (North America Clinical Dev) Operations

Employer
Novo Nordisk
Location
Plainsboro, NJ
Start date
Apr 13, 2024

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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

Provides daily people management to line of business managers (LoBMs) and individual contributors to ensure effective performance management, team collaboration, employee engagement, and recognition.

 

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, change management skills, and cross-TA collaboration and role consistency.

 

Accountability for quality and performance related managing clinical trial sites (i.e. data quality, document handling, and trial product handling, etc).

 

Relationships

Reports into 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 R&D, & 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 Portfolio Director and TA Heads
  • Analyze and Anticipate Business Needs: Utilizes knowledge of processes, talent, internal and external drivers, and industry standards and trends to inform and direct operations planning and strategy. Proven ability to proactively identifies opportunities/risks and partners with internal and external stakeholders and team members to develop, plan and execute on the opportunity or mitigation
  • People Management: Provides daily people management to line of business managers (LoBMs) and 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: Collaborating 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
  • Risk Management: Assessing and mitigating risks associated with operations, implementing measures and staying current with regulations/practices/industry trends
  • Cross-TA 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)
  • Stakeholder Management: Build strong internal and external relationships with key stakeholders across CMR, NNI, and HQ
  •  

    Physical Requirements

    10-20% overnight travel required. 10-20% 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 12 years’ experience in the design, planning and conduct of GCP clinical trials; with at least 8 of those most recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/CRO)
  • 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 8 years in a supervisory role in clinical development/trials required
  •  

    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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    Company info
    Website
    Phone
    617-612-6200
    Location
    75 Hayden Avenue
    Lexington
    MA
    02421
    US

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