Medical Director - Clinical Development and Research

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

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, NA CMR including Clinical Trial Management, Medical Affairs, Regulatory Affairs and other Novo Nordisk Inc. (NNI) skill areas. External relationships include expert advisory board members, investigators, regulators, academic and pharma associations and other consultants.

 

Essential Functions

• Evidence Generation Planning:
  • Provide regional medical & scientific input to regional evidence generation planning and project strategic documents, including NNI evidence Generation Plans and Product Development Plans
• Clinical Study Management
  • Provide regional medical & scientific input on trial outlines, trial protocols and 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

• Regulatory Liaison
  • Write and/or review clinical sections of clinical trial reports, statistical reports, investigator’s brochures, INDs, 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
• Medical and Scientific Support for Other Company Activities
  • 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 HEOR studies, RWE studies and value dossiers for market access
  • Provide medical and scientific input to Marketing/Market Access departments as needed

• Project Management Liaison:
  • Assist in developing clinical program timelines, budgets, and strategies
• Other Essentials:
  • Must maintain necessary credentials and remain in good standing with the medical community and medical ethics boards
  • Collaborate with other skill areas in NACD, CDSE, CMR and NNI in general to ensure seamless collaboration across skill areas

 

Physical Requirements

10-20% overnight travel required.

 

Qualifications

• MD or DO required; additionally, a PhD would be ideal, not required
• A minimum of 6 years relevant experience required; academic research or pharmaceutical development experience preferred
• Board certification or relevant therapeutic area experience required
• Prior clinical research or related experience (e.g., monitoring of clinical studies, knowledge of drug development phases, statistical research methodology experience)
• Leadership skills; project management skills; effective communication and presentation skills
• St