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    International Medical Director

    Novo Nordisk
    1+ years
    Not Disclosed
    Plainsboro
    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 – Liver Disease

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

    About the Department

    The Liver Disease Department at Novo Nordisk is based within the East Coast Global Development Hub, merging innovation, collaboration, and cutting-edge research to advance treatments for liver diseases like MASH (Metabolic Associated Steatohepatitis) and ALD (Alcoholic Liver Disease).

    Our team leverages biotech agility alongside pharmaceutical resources and quality to address key challenges in liver disease drug development. Focused on creating a vibrant R&D community, we emphasize collaboration, partnerships, and innovative modalities to bring new medicines to patients.

    We believe improving human health starts here, and patients rely on us. Are you ready to make a difference?

    The Position

    The International Medical Director is a subject matter expert in liver disease drug development and works on clinical development programs spanning preclinical through Phase 4. This position collaborates with cross-functional teams, designs and executes clinical trials, and assists in strategic planning for biomarkers, patient-reported outcomes (PROs), and scientific data interpretation.

    You will also partner with senior leadership to guide therapeutic area priorities while ensuring compliance with regulatory standards and trial integrity.

    Key Responsibilities

    Clinical Expertise & Trial Design

    • Serve as a liver disease subject matter expert for MASH and/or ALD programs to internal and external stakeholders.
    • Design clinical studies, draft protocols, and prepare regulatory and study-related documents.
    • Provide clinical leadership in trial execution, including data interpretation and reporting (e.g., abstracts, manuscripts).

    Strategic Collaboration

    • Partner with cross-functional teams (e.g., Clinical Operations, Non-Clinical Research, Medical Writing, Regulatory Affairs) to deliver clinical activities on time.
    • Contribute to biomarker and PRO strategy development for emerging programs.
    • Work with Global Project Teams to provide medical support for clinical-stage programs.

    Stakeholder & Regulatory Engagement

    • Interface with KOLs, principal investigators, and regulatory authorities to advance clinical objectives.
    • Act as a liaison with Safety Review Committees and Data Safety Monitoring Committees.

    Safety & Compliance

    • Ensure trials comply with ICH-GCP, SOPs, and national/international regulatory standards.
    • Participate in safety review meetings and contribute to medical monitoring.

    Data Management & Analysis

    • Collaborate on the development of Statistical Analysis Plans (SAPs) and oversee data integrity.
    • Assist in compiling regulatory submissions and responding to inquiries.

    Qualifications

    Education & Experience:

    • Required: MD (or international equivalent).
    • Preferred: Board-certified Hepatologist with clinical experience in MASH and/or ALD.
    • 1+ years in the pharmaceutical/biotech industry or academic clinical research.
    • Track record of scientific publications is highly desirable.

    Skills & Competencies:

    • Strong background in reviewing and interpreting scientific and clinical study data.
    • Ability to work collaboratively in a cross-functional, matrixed environment.
    • Excellent written and oral communication skills.
    • Demonstrates integrity, accountability, and adaptability in problem-solving.

    Additional Attributes:

    • Experience managing clinical trials is preferred.
    • Familiarity with clinical development strategies and regulatory compliance.
    • Innovative, forward-thinking approach to overcoming challenges.

    Physical Requirements

    • Travel: 10-20% overnight travel is expected.

    Equal Opportunity Employer

    Novo Nordisk is committed to diversity, inclusion, and providing equal opportunity to all applicants, regardless of race, gender, ethnicity, religion, sexual orientation, disability, or veteran status.

    If you require accommodations to apply, contact us at 1-855-411-5290 (for accommodation requests only).

    Apply Now: Novo Nordisk Careers

    Together, we’re life-changing.

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