International Medical Director
Novo Nordisk
7 months ago
Remote friendly (Lexington, MA)
United States
Medical Affairs
The International Medical Director serves as the clinical medical lead and subject matter expert for products and related data within a Therapeutic Area, responsible for the clinical development plan for one or more products in liver diseases. Leads design and execution of clinical trials and supports drafting medical/scientific documents, safety monitoring, and data analyses. Works with the Senior Medical Director on strategic priorities and helps develop PRO and biomarker strategies.
Location: Lexington, MA or Plainsboro, NJ; remote in certain cases.
Essential Functions:
- Participate in early to late-stage clinical development and critical decisions for liver disease programs.
- Serve as medical lead/expert drug developer; provide input and guidance to internal and external stakeholders.
- Deliver strategic clinical development support for liver programs, including potential expansion into adjacent indications.
- Provide clinical and scientific expertise for study design, protocol writing, and study/regulatory documents.
- Analyze and interpret data; ensure trial data integrity; support reporting (scientific summaries, abstracts, manuscripts).
- Provide leadership and medical oversight during trial conduct.
- Give internal/external oral presentations and co-author publications.
- Ensure compliance with SOPs, ICH, GCP, and national/international regulatory requirements.
- Coordinate with Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, Product Supply, and Regulatory Affairs to complete clinical activities.
- Lead/participate in internal review groups to resolve clinical development problems.
- Interface with regulatory authorities and support submissions, meeting packages, and responses.
Physical Requirement:
- 10–20% overnight travel required.
Qualifications:
- MD (or international equivalent) required; board certified hepatologist or clinical experience in hepatology preferred.
- Strong scientific background reviewing/interpreting scientific and/or study data required.
- Scientific publications strongly preferred.
- 1+ years pharmaceutical/biotech industry experience (including managing clinical trials) or academic clinical research background.
- Desirable: working knowledge of biostatistics, data management, clinical operations, and scientific/technical processes.
- Working knowledge of the drug development process.
- Team player in a matrix environment; able to work independently.
- Excellent written and oral communication skills.
- Integrity, honesty, high ethical standards, and personal accountability.
- Ability to adapt and provide innovative solutions.
Benefits (as stated): Eligible for company bonus; long-term incentive compensation and/or company vehicles (based on level); medical/dental/vision; life and disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance; tuition reimbursement; voluntary benefits (e.g., group legal, critical illness, identity theft protection, pet insurance, auto/home insurance); time off (sick time, flexible vacation) and parental leave.
Base compensation (as stated): $300,000–350,000 base.
Application instructions:
- If you need special assistance/accommodation to apply, call 1-855-411-5290 (accommodation requests only).
Location: Lexington, MA or Plainsboro, NJ; remote in certain cases.
Essential Functions:
- Participate in early to late-stage clinical development and critical decisions for liver disease programs.
- Serve as medical lead/expert drug developer; provide input and guidance to internal and external stakeholders.
- Deliver strategic clinical development support for liver programs, including potential expansion into adjacent indications.
- Provide clinical and scientific expertise for study design, protocol writing, and study/regulatory documents.
- Analyze and interpret data; ensure trial data integrity; support reporting (scientific summaries, abstracts, manuscripts).
- Provide leadership and medical oversight during trial conduct.
- Give internal/external oral presentations and co-author publications.
- Ensure compliance with SOPs, ICH, GCP, and national/international regulatory requirements.
- Coordinate with Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, Product Supply, and Regulatory Affairs to complete clinical activities.
- Lead/participate in internal review groups to resolve clinical development problems.
- Interface with regulatory authorities and support submissions, meeting packages, and responses.
Physical Requirement:
- 10–20% overnight travel required.
Qualifications:
- MD (or international equivalent) required; board certified hepatologist or clinical experience in hepatology preferred.
- Strong scientific background reviewing/interpreting scientific and/or study data required.
- Scientific publications strongly preferred.
- 1+ years pharmaceutical/biotech industry experience (including managing clinical trials) or academic clinical research background.
- Desirable: working knowledge of biostatistics, data management, clinical operations, and scientific/technical processes.
- Working knowledge of the drug development process.
- Team player in a matrix environment; able to work independently.
- Excellent written and oral communication skills.
- Integrity, honesty, high ethical standards, and personal accountability.
- Ability to adapt and provide innovative solutions.
Benefits (as stated): Eligible for company bonus; long-term incentive compensation and/or company vehicles (based on level); medical/dental/vision; life and disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance; tuition reimbursement; voluntary benefits (e.g., group legal, critical illness, identity theft protection, pet insurance, auto/home insurance); time off (sick time, flexible vacation) and parental leave.
Base compensation (as stated): $300,000–350,000 base.
Application instructions:
- If you need special assistance/accommodation to apply, call 1-855-411-5290 (accommodation requests only).