Novo Nordisk
Senior International Medical Director
Novo Nordisk, Lexington, Massachusetts, United States, 02173
Novo Nordisk Senior International Medical Director Lexington, Massachusetts Apply Now
Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. Our Novel Modalities department pioneers development of treatments with small interfering RNAs and monoclonal antibodies and oversees a robust pipeline of projects from early research through late-stage clinical development. We are building a multi-talented team of physician scientist drug developers that works together to tackle key challenges and opportunities in drug development to improve the lives of people with disease. 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 PositionThe 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 with prior research experience, either in academia or industry. In this role, the Senior International Medical Director helps develop products within the Novel Modalities team as the medical lead of the ATTR cardiomyopathy project. In doing so, the Senior International 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.RelationshipsReports to: Senior Director of the Novel Modalities department. Work with the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC, and Regulatory Affairs teams. Will interface with both internal and external stakeholders including KOLs and Principal Investigators.Essential FunctionsSupport the Novel Modalities team as a drug-developer for assigned programs to both internally and externally facing 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, CMC, 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 larger Global Project Team to deliver excellent medical support for clinical-stage programs.Interface with US/international regulatory authorities, as appropriate, in support of the development objectives and assist Regulatory Strategy staff in the compilation of submissions and in the responses to inquiries.Lend clinical expertise to the Statistical Analysis Plan development and data management, and work closely with statistical programming and data management on the project level.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 provide medical monitoring of ongoing clinical trials.Physical Requirements10-20% overnight travel expected.QualificationsMD or the international equivalent is required.4+ years of experience with clinical development from the pharmaceutical industry or biotech industry.Experience within the cardiovascular therapy area 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.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.
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Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. Our Novel Modalities department pioneers development of treatments with small interfering RNAs and monoclonal antibodies and oversees a robust pipeline of projects from early research through late-stage clinical development. We are building a multi-talented team of physician scientist drug developers that works together to tackle key challenges and opportunities in drug development to improve the lives of people with disease. 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 PositionThe 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 with prior research experience, either in academia or industry. In this role, the Senior International Medical Director helps develop products within the Novel Modalities team as the medical lead of the ATTR cardiomyopathy project. In doing so, the Senior International 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.RelationshipsReports to: Senior Director of the Novel Modalities department. Work with the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC, and Regulatory Affairs teams. Will interface with both internal and external stakeholders including KOLs and Principal Investigators.Essential FunctionsSupport the Novel Modalities team as a drug-developer for assigned programs to both internally and externally facing 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, CMC, 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 larger Global Project Team to deliver excellent medical support for clinical-stage programs.Interface with US/international regulatory authorities, as appropriate, in support of the development objectives and assist Regulatory Strategy staff in the compilation of submissions and in the responses to inquiries.Lend clinical expertise to the Statistical Analysis Plan development and data management, and work closely with statistical programming and data management on the project level.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 provide medical monitoring of ongoing clinical trials.Physical Requirements10-20% overnight travel expected.QualificationsMD or the international equivalent is required.4+ years of experience with clinical development from the pharmaceutical industry or biotech industry.Experience within the cardiovascular therapy area 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.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.
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