International Medical Director

Novo Nordisk

1+ 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: International Medical Director
Location: Lexington, United States
Job Category: Clinical Development

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About the Department:

At Novo Nordisk, our East Coast Global Development Hub is home to a diverse group of life science innovators located in Lexington, MA and Plainsboro, NJ. Our Novel Modalities department leads the development of treatments involving small interfering RNAs (siRNAs) and monoclonal antibodies and manages a strong pipeline from early research through late-stage clinical development. We are assembling a dynamic team of physician-scientist drug developers dedicated to addressing key challenges and advancing drug development in order to improve the lives of those with diseases. Our hub blends the agility of biotech with the resources of a large pharmaceutical company, providing a unique environment to drive cutting-edge research. Together, we’re committed to changing lives—are you ready to be part of it?

The Position:

The International Medical Director will serve as a subject matter expert for our products and related data in the ATTR cardiomyopathy project within the Novel Modalities team. This role involves collaboration across functional teams to support the design and execution of clinical trials, drafting of scientific documents, monitoring safety, and data analysis. The International Medical Director will also assist the Senior Medical Director in the development and execution of strategic priorities within the therapeutic area and contribute to the development of PRO (Patient-Reported Outcomes) and biomarker strategies.

Key Responsibilities:

Clinical and Scientific Expertise:

Provide expert clinical and scientific support for the ATTR cardiomyopathy project, working with both internal teams and external stakeholders.
Lead the design of studies, including protocol development and other regulatory documents.
Analyze and interpret trial data, ensuring the integrity of clinical findings and supporting the preparation of scientific summaries, abstracts, and manuscripts.

Clinical Trial Execution:

Ensure compliance with SOPs, ICH, GCP, and other regulatory requirements.
Collaborate with Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC, and Regulatory Affairs to ensure the timely completion of all clinical activities.
Actively contribute to internal review groups and leverage innovative methods to resolve clinical development challenges.

Regulatory and Safety Oversight:

Interface with regulatory authorities and assist the Regulatory Strategy team in the compilation of submissions and responses to inquiries.
Provide clinical input to the Statistical Analysis Plan and work closely with data management and statistical programming teams.
Participate in Safety Review Committees and Data Safety Monitoring Committees, ensuring proper medical monitoring during ongoing trials.

Physical Requirements:

10-20% overnight travel may be required.

Qualifications:

MD or the international equivalent is required.
1+ years of experience in the Pharmaceutical/Biotech industry, including managing clinical trials, or relevant academic clinical research background.
Experience in the cardiovascular therapy area is preferred.
Solid understanding of clinical development and experience in interpreting scientific and clinical data.
Scientific publications experience is strongly preferred.
Knowledge of biostatistics, data management, and clinical operations is desirable.
Team player with the ability to work collaboratively in a matrix environment.
Excellent communication skills, with integrity and the ability to resolve conflicts independently.

Why Join Novo Nordisk:

At Novo Nordisk, we are committed to being the best company for the world, and we know that this can only be achieved by fostering a diverse, inclusive environment. We celebrate the diverse perspectives, backgrounds, and cultures of our employees and the communities we serve. Together, we are life-changing. Join us on our journey to make a global impact.

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