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    Senior International Medical Director

    Novo Nordisk
    4+ years
    Not Disclosed
    Lexington
    10 Jan. 3, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior International Medical Director
    Location: Lexington, United States
    Job Category: Medical Affairs

    Apply Now

    About the Department:

    At Novo Nordisk, our East Coast Global Development Hub, located in Lexington, MA and Plainsboro, NJ, drives life science innovation. We focus on pioneering treatments, particularly in small interfering RNAs and monoclonal antibodies, overseeing a diverse and expanding pipeline from early research to late-stage clinical development. Our Novel Modalities team is committed to building a multi-talented community of drug developers to address key challenges in drug development and improve patient outcomes. We combine biotech agility with the resources and stability of a large pharmaceutical company to develop new medicines. If you are passionate about making a difference, we invite you to join us on this transformative journey.

    The Position:

    We are seeking an experienced Senior International Medical Director to lead the ATTR cardiomyopathy project within our Novel Modalities department. This position offers the opportunity to contribute to the development of cutting-edge treatments by providing medical and scientific expertise across clinical trials, data analysis, safety monitoring, and regulatory documentation. The Senior International Medical Director will lead strategic initiatives within the cardiovascular therapeutic area, collaborating with multiple teams and external stakeholders to drive the success of clinical programs.

    Key Responsibilities:

    Clinical and Scientific Leadership:

    • Serve as the medical lead for the ATTR cardiomyopathy program, providing clinical expertise to the design of studies, writing protocols, and preparing regulatory documents.
    • Contribute to the analysis and interpretation of clinical data, ensuring trial data integrity and assisting with the preparation of scientific summaries, abstracts, and manuscripts for publication.
    • Lead the execution of clinical trials, ensuring compliance with SOPs, ICH, GCP, and other national and international regulations.

    Collaboration & Cross-Functional Support:

    • Work with Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC, and Regulatory Affairs teams to deliver on clinical-stage program goals and timelines.
    • Interface with US/international regulatory authorities to support development objectives and assist with regulatory submissions and responses to inquiries.
    • Collaborate with the Global Project Team to provide medical support for emerging clinical-stage programs.

    Clinical Development Oversight:

    • Participate in internal review groups, offering novel solutions to clinical development challenges.
    • Support the Statistical Analysis Plan development and collaborate with statistical programming and data management teams.
    • Act as a liaison between the company, clinical site investigators, and Key Opinion Leaders (KOLs).
    • Participate in Safety Review Committees and Data Safety Monitoring Committees for ongoing clinical trials.

    Physical Requirements:

    • 10-20% overnight travel required for site visits and stakeholder engagement.

    Qualifications:

    Education & Experience:

    • MD or equivalent international degree required.
    • Minimum of 4 years of experience in clinical development within the pharmaceutical or biotech industry.
    • Cardiovascular therapy experience is preferred.

    Skills & Knowledge:

    • Strong background in reviewing and interpreting scientific and study data.
    • Proven track record of scientific publications is highly preferred.
    • Team-oriented with the ability to collaborate in a matrix environment.
    • Independent problem-solver with excellent written and oral communication skills.
    • Strong integrity, honesty, and a sense of personal accountability.
    • Ability to quickly adapt and provide innovative solutions to challenges as they arise.

    Why Join Novo Nordisk:

    At Novo Nordisk, we are committed to creating a diverse and inclusive culture where all employees feel valued. We believe that diverse perspectives drive innovation and we are dedicated to reflecting the communities we serve. By joining us, you become part of a mission to change lives and help improve global health.

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    Bucharest |

    Makkah :

    Jeddah | Rabigh | Najran | King Abdullah Economic City | Khulais | Riyadh |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Sao paulo | Brazil |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |