Senior International Medical Director
: Job Details :

About the Department

Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development 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. We recognize that improving human health starts here and that patients rely on us. We're changing lives for a living. Are you ready to make a difference?

The Position

The Senior International Medical Director serves as a subject matter expert for our products and related data within a therapeutic area. The Senior International Medical Director is a team player, detail oriented, ideally with prior research experience from either academia or industry.

In this role, the Senior International Medical Director will be the medical lead for clinical development of projects in the ALD therapy area. The successful applicant will work with different functional teams to support the design and execution of clinical trials, the drafting of medical/ scientific documents, safety monitoring, and data analyses. The Senior International Medical Director will also be the medical lead for the development and execution of strategic priorities within the therapeutic area, including PRO and biomarker strategies.

Relationships

Reports to: Senior Director of the Liver Disease department.

Work with the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams.

Will be interfacing with both internal and external stakeholders including KOLs and Principal Investigators.

Essential Functions

• Support the ALD clinical development program as medical lead and expert drug developer, providing input and guidance to both internal and external stakeholders

• 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

• 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

• Work with the Global Project Team to deliver strategic clinical development support for the ALD programs

• 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

• Lend clinical development expertise to the Statistical Analysis Plan development and data management, and work closely with statistical programming and data management

• Act as a liaison between the company and clinical site investigators and KOLs

• Interface with Safety Review Committees and Data Safety Monitoring Committees

• Participate in safety review meetings and conduct medical monitoring of ongoing clinical trials

Physical Requirements

10-20% overnight travel expected.

Qualifications

• MD or the international equivalent is required
4+ years of clinical drug development experience from the pharmaceutical or biotech industryScientific training at PhD level or equivalent preferably within basic and/or clinical research is preferred
• Scientific background with experience in reviewing & interpreting scientific and study data is required
• Track record of scientific publications strongly preferred
• 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

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.

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-###-####. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.