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Medical Director - Clinical Development & Research

Employer
Novo Nordisk
Location
Plainsboro, NJ
Start date
May 7, 2024

View more

Discipline
Clinical, Clinical Development, Clinical Research
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Best Places to Work

Job Details

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 Research & Development. Internal relationships include working with Headquarters, 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

  • Evidence generation planning:
  • Provide regional medical & scientific input to regional evidence generation plan-ning 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 Initia-tion 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 re-quested
    • 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 & critical new tech-nologies 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 time lines, budgets, and strategies
  • Other essentials:
  • Must maintain necessary credentials and remain in good standing with the med-ical community and medical ethics boards
  • Collaborate with other skill areas in CDOR, CMR and NNI in general to ensure seamless collaboration across skill areas
  •  

    Physical Requirements

    10-20% overnight travel required.

     

    Qualifications

    • M.D. 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 in diabetes, CV or Obesity 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
    • Strong collaborative mindset required
    • Must maintain necessary credentials and remain in good standing within the medical community and medical ethics boards its except those already vested, provided

     

     

    We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

     

    At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

     

    Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

     

    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.

    Company

    Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

    Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

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    Company info
    Website
    Phone
    617-612-6200
    Location
    75 Hayden Avenue
    Lexington
    MA
    02421
    US

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