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BRIAN PERRELLA
CHERYL PEDOTA
Prabhdeep Singh
USA

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VP - CLINICAL DEV & OUTCOMES RESEARCH Job

Date: May 12, 2019

Location: Plainsboro, NJ, US

Company: Novo Nordisk

About the Department

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk, Inc. (NNI) 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.


Position Overview


The Vice President - Clinical Development & Outcomes Research serves as the Head of Clinical Development & Research (CDR), Health Economics and Outcomes Research (HEOR) and Real World Evidence (RWE). As a member of the NNI Clinical Medical Regulatory Management (CMR) Team the VP will provide strategic leadership, and medical and scientific support for all therapeutic areas within NNI. Within these therapeutic areas, the VP is responsible for Phase I through IV clinical development as well as RWE/RWD in the United States in support of Global Development and local market needs. Individual will lead, mentor, and ensure training of the NAO Project teams as well as interface with Global Project Teams (GPT) and Project Vice Presidents to facilitate and advance Global Development Plans by providing integrated and consolidated US input to development activities. Sharing best practices, attaining consistency across regions and across projects, and optimizing resource utilization is key to the role. Interface with Discovery, Marketing, Market Access & Public Affairs, Medical Affairs and U.S and global Regulatory counterparts to design and implement the overall global development strategy for the Novo Nordisk portfolio across all therapeutic areas.


Relationships


Reports to the Senior Vice President of Clinical Development, Medical and Regulatory Affairs and is accountable for managing multiple internal relationships within NNI (e.g. Market Access & Public Affairs, Marketing, CMR areas and Legal Affairs) and NNAS (including Global Development, Market Access & Public Affairs and Global Project Teams in general). External relationships include working with national societies, key opinion leaders (KOLs), advisory boards and consultants, as well as the broader medical community and health systems.


Essential Responsibilities
  • Proactively share medical, scientific and regulatory best practice with relevant Global functions and other CMR regions. Includes but not limited to hosting meetings at NNI for development projects, clinicians attending GPT and/or Medical & Science meetings and active participation in the Global Medical Management Council. Is overall responsible for the organizing and conducting the North America Portfolio Advisory Board (NA PAB) in the US in collaboration with the Global CMO office
  • Drive personal and team development of leaders and employees in terms of clinical and scientific expertise, drug development methodology, RWE and RWD capabilities as well as leadership capabilities and team management skills. Attend relevant scientific meetings, conferences and courses
  • Primary ownership for the NAO Evidence Generation planning process. Drive development of integrated (Clinical Development as well as RWE), long term Evidence Generation Plans for key products and secure alignment and synergies across the portfolio. Ensure direction and leadership to NAO Project teams and foster cross-functional and cross-organizational collaboration and alignment
  • Primary ownership for the NAO product development plan (PDP) process including coordination and content, supported by the NAO PDP Forum Secretariat. Overall responsible for planning, preparation, execution and communicating outcome from the NAO PDP Forum meetings as well as ensuring Senior Vice President (SVP), CMR is fully apprised for Global PDP Council meetings
  • Oversee and provide strategic guidance for all medical and scientific aspects of clinical trials in North America, including input to PDP’s, Trial Outlines and Protocols as well as training activities
  • Coordinate Novo Nordisk medical and scientific input into global regulatory agencies for development projects; providing medical representation at Regulatory meetings and coordinating medical and scientific input to advisory committee
  • Oversee all activities for Investigator Sponsored Studies in NNI, including compliance and alignment with Global strategies
  • Oversee and provide strategic guidance for all HEOR, RWE and RWD activities in NNI and ensure alignment with NNI enterprise strategy, portfolio and product strategies as well as Global strategies. Drive understanding and appropriate use of RWE and RWD in the organization and secure compliant processes are in place
  • Participate as a strategic, contributing member of the CMR senior leadership team and oversee NNI due diligence and other senior level oversight associated with the role
  • Foster development of relationships with US and Global KOL’s and thought leaders, including but not limited to the function, serving as a driver toward Novo Nordisk’s goal of being a “Center of Excellence” in global clinical development and representing the company in external professional societies, pharma associations, seminars and conventions


Qualifications
  • PhD or MD required, with 12+ years industry experience
  • 5+ years of experience from at least one of the relevant areas of Clinical Development, HEOR or RWE/RWD
  • Pharmaceutical development or research experience, including expertise in clinical trial methodology, pragmatic trials, observational studies, statistical research methodology, medical product support and regulatory experience preferred
  • Managerial responsibilities in an institutional setting required
  • Comprehensive understanding of the US Healthcare system as well as market - and patient - access dynamics required
  • Previous experience leading a complex matrixed organization, management of managers
  • Strong interpersonal, collaborative, relationship building and communication skills
  • Demonstrable strategic and tactical planning experience within a pharmaceutical environment is required
  • Must maintain necessary credentials and remain in good standing within the medical/scientific community

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.


Requisition ID: 59772BR
State/Provinces: Plainsboro
Job Category: Clinical Development


Nearest Major Market: New Jersey

Job Segment: Clinic, Medical, Medical Research, Clinical Research, Healthcare, Research