- Support the Head of GNAT Program Initiation and Clinical Development as the US/international clinical lead for one or more internal GalXC or other development programs, interacting with both internal and externalstakeholders
- In conjunction with other relevant functional areas, help develop/ refine the strategic development plan for GalXC clinical development programs and other emerging novel therapeutics
- Provide clinical and scientific expertise to the design of studies, writing of protocols and other study and regulatory-related documents Dicerna TRU early clinical development programs
- 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 internal SOPs, ICH GCP, and other national and international regulatory requirements
- Work with the VP GNAT ED, and early clinical development functions such as Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC, and Regulatory Affairs to deliver and drive timely completion of all activities related to early clinical development programs
- Serve as a leading member or participant at internal review groups, and utilize novel and creative methods to resolve clinical development problems
- Work with the Lexington-based Boston Clinical Development group and contribute as a member of one or more Global Project Teams that are part of the Novo Nordisk organization, delivering excellent medical support to clinical development programs at all stages
- Interface with US/international regulatory authorities, as appropriate, in support of the development objectives for clinical programs, assisting Regulatory Affairs staff in compilation of submissions and responses to inquiries from regulatory authorities
- Leverage medical expertise in clinical specialty and subspecialty areas of training and certification (preferably related to endocrinology, diabetes, obesity, and metabolic disease) to guide and educate GNAT and the global Novo Nordisk organization regarding emerging advances and innovative opportunities in these therapeutic areas
- Lend clinical expertise to members of the biostatistics and data management groups as part of interactions atthe project level
- Act as a liaison between the company and external stakeholders such as clinical site investigators and KOLs
- Interface together with GNAT Head of Program Initiation and VP GNAT ED Development with internal Safety Review Committees and independent Data Safety Monitoring Committees
- Participate in safety review meetings and providing medical monitoring of ongoing clinical trials Physical Requirements 0-10% overnight travel required. Ability to lift 0-10 lbs. Qualifications
- MD or the international equivalent is required. Specialty and subspecialty training and expertise in indications that are at the core of Novo Nordisk's therapeutic interests, such as endocrinology, diabetes, obesity, and metabolic disorders are highly desired
- Strong scientific background with experience in reviewing & interpreting scientific and clinical trial data is required
- Clinical development experience in the therapeutic areas aligned with Novo Nordisk's disease focus of diabetes, obesity, and/or cardiovascular disease preferred
- Track record of scientific publications strongly preferred
- 2+ years Pharmaceutical/Biotech industry experience desired, 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 applicable US and EU regulatory requirements and of the drug development process
- Experience in building and maintaining effective relationships with external KOL's, advisory boards and other key external therapeutic area influencers desirable
- Proficiency in English required, and ability to converse or understand multiple additional languages desired but not required
- 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 This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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Medical Director - Lexington, United States - Novo Nordisk
Description
About the Department
Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge 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 greater Boston 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.
The Position
The Global Nucleic Acid Therapies (GNAT) Early Development (ED) unit within Novo Nordisk is seeking an enthusiastic research-oriented physician with solid scientific acumen who is excited by cutting-edge biotechnology and wishes to take part in the unique opportunity to bring innovative pharmaceutical products through clinical development to market. The candidate is a team player, detail oriented with prior research experience, ideally both in academic medicine and in pharma or biotech. The GNAT ED unit currently focuses on bringing compounds utilizing RNA interference (RNAi) technology into and through early clinical development.
As a primary responsibility, the Medical Director will participate on several cross-functional teams to plan, design, execute, and analyze first-in-human clinical studies and early proof-of-concept clinical trials conducted within the GNAT ED unit. The successful candidate will work with a nimble and dynamic team, where an emphasis will be place on completing trials that inform both the safety and potential efficacy of the drug candidate. The role will entail diverse skills and make key contributions to the strategic direction of the GNAT clinical development portfolio, as well as serving as the medical lead for several GNAT early development programs. This physician will also use their clinical and drug development background to assist a diverse team in identifying indications that may be best suited to RNAi. In this high visibility position, the candidate will be interfacing with both internal and external stakeholders including Novo Nordisk senior leadership and external Key Opinion Leaders (KOLs) and Principal Investigators (PIs).
Relationships
Reports to: GNAT Head, Early Program Initiation and Clinical Development.
Works with the VP GNAT ED, and early clinical development functions including Non-Clinical Research, Bioanalytics, Clinical Operations, Medical Writing, Program Management, CMC and Regulatory Affairs.
Interfaces with both internal GNAT and Novo Nordisk global development leadership, and external stakeholders including KOLs and PIs.
Essential Functions
