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    International Medical Director

    Novo Nordisk
    1+ years
    Not Disclosed
    Lexington
    10 Jan. 8, 2025
    Job Description
    Job Type: Full Time Education: MD 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: International Medical Director

    Location: East Coast Global Development Hub (Lexington, MA & Plainsboro, NJ)
    Company: Novo Nordisk

    About the Department

    Novo Nordisk’s East Coast Global Development Hub unites cutting-edge life sciences innovation with global expertise. With facilities in Lexington, MA, and Plainsboro, NJ, the Novel Modalities department pioneers treatments using small interfering RNAs and monoclonal antibodies, overseeing a robust pipeline from early research to late-stage clinical development.

    We are cultivating a dynamic team of physician-scientist drug developers to address critical challenges and opportunities in drug development. Our collaborative and innovative approach merges biotech agility with pharmaceutical-quality resources to improve patients’ lives. Are you ready to make a difference?

    The Position

    As an International Medical Director, you will be a subject matter expert (SME) for products and data within a therapeutic area, particularly focusing on the ATTR cardiomyopathy project. You will collaborate across functional teams to support clinical trial design, data analysis, safety monitoring, and the development of scientific documents.

    This position also involves assisting the Senior Medical Director in strategic execution within the therapeutic area, including the development of patient-reported outcomes (PRO) and biomarker strategies.

    Key Responsibilities

    Drug Development & Clinical Expertise

    • Serve as a drug development expert for the Novel Modalities team across internal and external stakeholders.
    • Design clinical studies, draft protocols, and oversee regulatory-related documentation.
    • Analyze, interpret, and ensure the integrity of trial data.
    • Contribute to scientific reporting, including abstracts, summaries, and publications.
    • Provide medical leadership in the execution of clinical trials, ensuring compliance with SOPs, GCP, ICH, and global regulatory standards.

    Collaboration & Leadership

    • Partner with Clinical Operations, Non-Clinical Research, Medical Writing, CMC, and Regulatory Affairs teams to achieve program milestones.
    • Work with the Global Project Team to provide superior medical support for clinical-stage programs.
    • Interface with US and international regulatory authorities to support development objectives.
    • Act as a liaison with clinical site investigators, Key Opinion Leaders (KOLs), and Data Safety Monitoring Committees.

    Strategic Contributions

    • Participate in safety review meetings and provide medical monitoring for ongoing trials.
    • Contribute clinical expertise to Statistical Analysis Plan development, data management, and statistical programming.
    • Serve as a leading member of internal review groups to address clinical development challenges creatively.

    Physical Requirements

    • 10–20% overnight travel is required.

    Qualifications

    Education

    • MD or international equivalent required.

    Experience

    • 1+ years in pharmaceutical/biotech clinical development or academic clinical research.
    • Experience managing clinical trials, preferably in the cardiovascular therapy area.
    • Strong scientific background with expertise in reviewing and interpreting clinical data.

    Skills

    • Familiarity with biostatistics, data management, and clinical operations processes.
    • Understanding of the drug development lifecycle.
    • Strong publication record preferred.

    Attributes

    • Collaborative team player with problem-solving skills in a matrixed environment.
    • Excellent written and oral communication skills.
    • Integrity, ethical standards, and accountability.
    • Adaptability and innovation in addressing challenges.

    Equal Opportunity Employer

    Novo Nordisk values diversity and inclusion, striving to be the best company for the world by fostering a collaborative and innovative workplace. We welcome applicants from diverse backgrounds and ensure equal opportunity for all.

    For accommodation requests during the application process, contact us at 1-855-411-5290.

    Apply Now: Novo Nordisk Careers

    Together, we’re life-changing.

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