Senior Medical Director - Dicerna TRU

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 Dicerna Transformational Research Unit (TRU) within Novo Nordisk is seeking an enthusiastic Senior Medical Doctor with a high degree of scientific acumen who is excited by cutting-edge biotechnology and wishes to take part in the unique opportunity to bring highly innovative pharmaceutical products through clinical development to market. The candidate is a team player, detail oriented with prior research experience, ideally both in in academic medicine and in pharma or  biotech.

As a primary responsibility, the Senior Medical Director will work across different functional teams to plan, design, execute, and analyze early clinical development and proof-of-concept trials conducted by the TRU. The successful candidate will be a team player to work with a small but dynamic TRU team, where an emphasis will be place on completing trials that optimally inform both the safety and potential efficacy of the drug candidate.  The role will entail highly diverse skills, including strategic direction of the TRU portfolio, as well as serving as the medical lead for several TRU early development programs. This physician will also use their clinical and drug development background to assist a diverse TRU 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 TRU and Novo Nordisk senior leadership and external KOLs and Principal Investigators.

Relationships

Reports to: TRU Head, Early Program Initiation and Clinical Development. Work with the VP TRU Early Development, preclinical development including Non-Clinical Research Clinical Operations, , Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal TRU and Novo Nordisk global development leadership, and external stakeholders including KOLs and Principal Investigators.

Essential Functions

• Support the Head of TRU Program Initiation and Clinical Development as the US/international clinical lead for one or more internal GALXC or other development program to both internally and externally facing stakeholders
• In conjunction with other relevant functional areas, help develop/ refine the strategic development plan for TRU 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 SOPs, ICH, GCP and other national and international regulatory requirements
• Work with the TRU VP Early Development, 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 TRU early clinical development 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 TRU, Boston Clinical Development and Global Project Teams that are part of the Novo Nordisk organization to deliver excellent medical support development programs at all stages
• Interface with US/international regulatory authorities, as appropriate, in support of the development objectives for clinical programs assist Regulatory Strategy staff in the compilation of submissions and in the responses to inquiries
• Leverage medical expertise in clinical specialty and subspecialty areas of training and certification to guide and educate TRU and Global Novo Nordisk organization to emerging advances and innovative opportunities in these therapeutic areas
• 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 together with TRU Head of Program Initiation and TRU VP Early Development with Safety Review Committees and Data Safety Monitoring Committees
• Participate in safety review meetings and providing medical monitoring of ongoing clinical trials

Physical Requirements

Boston Research & Development Hub. Approximately 5-10% overnight travel. Ability to lift 0-10 lbs.

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. Specialty and subspecialty training and expertise in indications that are at the core of Novo Nordisk’s therapeutic interests, such as diabetes, obesity, endocrine disease, and/or orphan or rare diseases desired
• Strong scientific background with experience in reviewing & interpreting scientific and study 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
• 3+ 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 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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.