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Senior Medical Director - Clinical Development & Research - NASH

Facility:  Clinical Development and Medical
Location: 

Plainsboro, NJ, US

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

Scientific leader independently overseeing and collaborating on regional and global clinical strategic development plans within assigned therapeutic area. 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 leadership in other aspects of company activities in the assigned therapeutic area. Collaborate with global clinical development to facilitate and advance global development by sharing best practices, attaining consistency across regions and across projects.

 

Relationships

Reports to the Executive Director - Clinical Development & Research. Internal relationships include working with Headquarters, North America (NA) Clinical Medical Regulatory (CMR) including Clinical Trial Management, Medical Affairs, Regulatory Affairs, marketing, market access, legal 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

  • Co-chair the North American evidence generation planning teams for preapproval products and through these - drive strategic planning of evidence generation needs for NN in the region
  • Provide regional medical & scientific input to regional evidence generation planning and project strategic documents, including NNI Evidence Generation Plans and Product Development Plans
  • Challenge the scientific, regulatory, and marketing assumptions and objectives of developmental plans and clinical trials
  • Oversee the development and provide medical oversight of the clinical studies within the independent area of expertise
  • 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
  • Coordinate the involvement of the medical liaisons in supporting a clinical trial including type of support and training (as required)
  • Obtain expert medical community input
  • Represent Clinical, Medical and Regulatory affairs (CMR) organisation in global teams (global project team and/or medical and science teams) and influence strategic project decisions.
  • Support Novo Nordisk’s goal of being a “Center of Excellence” in global clinical development
  • Assist in providing medical representation at Regulatory meetings
  • Write and/or review clinical sections of clinical trial reports, statistical reports, investigator’s brochures, Investigational New Drugs (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 labeling
  • Assist in the interpretation of regulatory guidelines and directives to judge risk and causality
  • Stay abreast of guidelines, current trends, regulatory requirements 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, regulatory interactions, 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 timelines, budgets, and strategies
  • Through the project team, ensure timely initiation and completion of planned development activities including evidence generation plan and clinical studies
  • Must maintain necessary credentials and remain in good standing with the medical community and medical ethics boards
  • Collaborates with other skill areas in Clinical Development & Outcomes Research (CDOR), CMR and NNI in general to ensure seamless collaboration across skill areas

 

Physical Requirements

10-20% overnight travel required.

 

Qualifications

  • M.D. required with a PhD additionally desired
  • A minimum of 6 years’ experience required - >3 years clinical and > 3 years of pharmaceutical experience desired
  • Relevant therapeutic area experience desired. Board certification in relevant therapeutic area desired
  • 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
  • Strong collaborative mindset required
  • Necessary credentials and in good standing within the medical community and medical ethics boards

 

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.