International Medical Director
3 weeks ago
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 Medical Director serves as the subject matter expert for our products and related data within a Therapeutic Area. The Medical Director is a team player, detail oriented with prior research experience, either in academia or industry.
In this role, Medical Director helps develop multiple products within the liver disease team working with MASH and ALD projects covering clinical drug development from preclinical assessment through Phase 1-4.. In doing so, the Medical Director will work across different functional teams to support the design and execution of clinical trials, the drafting of medical/ scientific documents, safety monitoring, and data analyses. The Medical Director will also assist the Sr. Medical Director in the development and execution of strategic priorities within a therapeutic area, help develop PRO and biomarker strategies.
Relationships
Reports to: Senior Medical Director
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 MASH and ALD team as the clinical lead for assigned programs to both internally and externally facing stakeholdersProvide clinical and scientific expertise to the design of studies, writing of protocols and other study and regulatory-related documentsParticipate 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 manuscriptsProvide leadership in the execution of clinical trialsEnsure compliance with SOPs, ICH, GCP and other national and international regulatory requirementsWork with, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely completion of all clinical activities related to emerging clinical-stage programsServe as a leading member, or participant, at multiple internal review groups and utilize novel and creative methods to resolve clinical development problemsWork with the larger Global Project Team to deliver excellent medical support for clinical-stage programsInterface with US/international regulatory authorities, as appropriate, in support of the development objectives for the and assist Regulatory Strategy staff in the compilation of submissions and in the responses to inquiriesLend clinical expertise to the Statistical Analysis Plan development and data management, and work closely with statistical programming and data management on the project levelAct as a liaison between the company and clinical site investigators and KOLsInterface with Safety Review Committees and Data Safety Monitoring CommitteesParticipate in safety review meetings and providing medical monitoring of ongoing clinical trials Physical Requirements 10-20% overnight travel required. QualificationsMD or the international equivalent is required1+ years Pharmaceutical/Biotech industry experience, including time managing clinical trials, or academic clinical research backgroundWorking knowledge of the drug development process required.Strong scientific background with experience in reviewing & interpreting scientific and study data is requiredTrack record of scientific publications strongly preferredTeam player who works collaboratively in a challenging team matrix environmentAbility to work independently to resolve challenges and conflictsExcellent written and oral communication skillsIntegrity, honesty and highest ethical standards and a sense of personal accountabilityQuickly 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 This contact is for accommodation requests only and cannot be used to inquire about the status of applications.-
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