Life-Changing
Careers

BRIAN PERRELLA
CHERYL PEDOTA
Prabhdeep Singh
USA

Share this Job

Director - Clinical Development & Research Job

Date: Aug 14, 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. Are you ready to make a difference?


The Position
Use medical and clinical expertise in design, implementation and monitoring of clinical studies (from Phase 1 to 4) in a team setting. Provide medical and scientific support in other aspects of company activities in the assigned therapeutic area.


Relationships
Reports to the Executive Director - Clinical Development & Research. Internal relationships include working with Headquarters, North America (NA) CMR including Clinical Trial Management, Medical Affairs, Regulatory Affairs and other NNI skill areas. External relationships include expert advisory board members, investigators, regulators, academic and pharma associations and other consultants.


Essential Functions
  • Provide regional medical & scientific input to regional evidence generation planning and project strategic documents, including NNI evidence Generation Plans and Product Development Plans
  • Provide regional medical & scientific input on trial outlines, trial protocols and informed consent form (ICF)
  • Provide input on country and site feasibility, as well as Site Selection and Initiation trainings for the monitors
  • Review medical monitoring plan and conduct monitoring activities as per the plan
  • Manage all required local protocol amendments/deviations
  • Assist in the recruitment of investigators for clinical studies and provide medical support to investigator meetings
  • Provide protocol training, disease specific training and titration training
  • Assure timely initiation of studies; act as liaison with Regulatory, project teams, and investigators. Support recruitment & retention activities
  • Obtain expert medical community input
  • Write and/or review clinical sections of clinical trial reports, statistical reports, investigator’s brochures, Investigational new drug application (INDs), New drug application (NDA) and responses to Regulatory questions
  • Provide medical and scientific input to advisory committee hearings when requested
  • Provide medical and scientific input to labelling
  • Assist in the interpretation of regulatory guidelines and directives to judge risk and causality
  • Stay abreast of guidelines, current trends and medical practice in the assigned therapeutic area, including reports and intelligence on key and critical new technologies or treatment advances
  • Represent NN in investigators’ and expert advisory board meetings, external professional societies, pharma associations, seminars, and conventions
  • Provide medical and scientific input to Health Economics & Outcomes Research (HEOR) studies, Real World Evidence (RWE) studies and value dossiers for market access
  • Provide medical and scientific input to Marketing/Market Access departments as needed
  • Assist in developing clinical program time lines, budgets, and strategies
  • Must maintain necessary credentials and remain in good standing with the medical community and medical ethics boards
  • Collaborate with other skill areas in Clinical Development & Outcomes Research (CDOR), CMR and NNI in general to ensure seamless collaboration across skill areas

Physical Requirements
0-10% overnight travel required.


Qualifications
  • MD required with a PhD additionally desired
  • A minimum of 6 years relevant experience required; pharmaceutical experience preferred
  • Relevant therapeutic area experience desired, Board certification in relevant therapeutic area desired

Novo Nordisk is an Equal Opportunity Employer /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: 60147BR
State/Provinces: Plainsboro
Job Category: Clinical Development


Nearest Major Market: New Jersey

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