Director – Site Management

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Company: Novo Nordisk
Location: Princeton, NJ

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  • Clinical Development and Medical
  • Princeton

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?


The Position

Provides strategic & tactical leadership to staff, including line/business managers, within the Site Management (SM) 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. 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 SM and NACO and by efficiencies and optimization of organizational resource allocation. Accountability for quality and performance related to managing clinical trial sites, document handling and trial product handling.


Relationships

Reports to head of Site Management 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, CMR, International Operations (IO), HQ R&D, & Commercial). Supervisory responsibilities for a function within Site Management, including both direct & indirect reports.


Essential Functions

  • 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, including assessment and allocation of resources for in house CRAS/Document Management staff/Site Specialists, training and operational aspects of planning and managing site performance, documentation strategies, protocols and processes
  • Develops & oversees relevant contracts & budgets – including compiling, forecasting, tracking & revising
  • Formulates & drives the objective setting, prioritization & tracking within SM & 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


Physical Requirements

Approximately 10-20% overnight travel required (with notice). May on occasion be required to work &/or travel on weekends &/or company holidays.


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 (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 directly 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 ICH-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.

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.