International Medical Director
Lexington, MA, US
About the Department
Our Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown, Cambridge and Plainsboro reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients.
You will join a dynamic team consisting of a Team Lead and 8 Medical Specialists. This team operates across the full clinical spectrum, driving both early and late-stage development programs. The portfolio focuses on innovative liver disease assets, but also includes a late-stage cardiomyopathy asset. The team is anchored across two sites (Lexington, MA and Plainsboro, NJ) and also has one remote working team member.
The Position
The International Medical Director serves as the clinical medical lead and subject matter expert for our products and related data within a Therapeutic Area. The International Medical Director is a team player, detail oriented and strategic minded with prior research experience, either in academia or industry, preferably in the field of liver health. In this role, the International Medical Director is responsible for the clinical development plan for one or more products in the therapeutic area of liver diseases. The International Medical Director will work across different functional teams to lead the design and execution of clinical trials, and support the drafting of medical/ scientific documents, safety monitoring, and data analyses. The International Medical Director will work with the Senior Medical Director in the development and execution of strategic priorities within the liver disease therapeutic area, help develop PRO and biomarker strategies.
This position can be based out of Lexington, MA, Plainsboro, NJ and in certain cases a remote position will also be considered.
Relationships
Reports to: Director or Senior Director, Medical &Translational Science (M&TS). Work with Clinical Operations, Global Patient Safety, Global Medical Affairs, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and external stakeholders including Scientific experts, Health Authorities, Study Investigators and governance boards.
Essential Functions
- Be part of early to late-stage clinical development and the critical discussions/decisions that will pave the way for the clinical development program for different compounds with diverse mechanism of action in the therapeutic area of Liver diseases
- Support the clinical development program(s) as medical lead and expert drug developer, providing input and guidance to both internal and external stakeholders
- Work with the Global Project Team to deliver strategic clinical development support for the Liver programs, including plans for potential expansion into adjacent indications
- Provide clinical and scientific expertise to the design of studies, writing of protocols and other study and regulatory-related documents
- Participate in the analysis and interpretation of data, ensure integrity of trial data, and assist in reporting of study results including preparation of scientific summaries, abstracts and manuscripts
- Provide leadership in the execution of clinical trials including medical oversight during trial conduct
- Give oral presentations internally and externally and co-author publications
- Ensure compliance with SOPs, ICH, GCP and other national and international regulatory requirements
- Work with Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, Product Supply and Regulatory Affairs teams to deliver and drive the timely completion of all clinical activities related to emerging clinical-stage programs
- Serve as a leading member, or participant, at multiple internal review groups and utilize novel and creative methods to resolve clinical development problems
- Interface with regulatory authorities as appropriate in support of the development objectives for the project, and assist regulatory colleagues in the compilation of submissions, meeting packages, and responses to inquiries
Physical Requirements
10-20% overnight travel required.
Development of People
Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
Qualifications
- MD or the international equivalent is required; board certified hepatologist or clinical experience in hepatology preferred
- Strong scientific background with experience in reviewing & interpreting scientific and/or study data is required
- Track record of scientific publications strongly preferred
- 1+ years Pharmaceutical/Biotech industry experience, including time managing clinical trials, or academic clinical research background
- Working knowledge of biostatistics, data management, clinical operations and scientific and technical processes desirable
- Working knowledge of the drug development process
- Team player who works collaboratively in a challenging team matrix environment
- Ability to work independently to resolve challenges and conflicts
- Excellent written and oral communication skills
- Integrity, honesty and highest ethical standards and a sense of personal accountability
- Quickly adapt and provide innovative solutions to challenges as they present themselves
The base compensation range for this position is $300,000-350,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.
Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.