Job Information
Novo Nordisk Medical Director (Early Clinical Development) in Lexington, Massachusetts
About the Department
The Global Nucleic Acid Therapies area strives to be a global leader in nucleic acid therapeutics by developing innovative technology platforms and molecules that translate into novel genetic medicines to improve patients' lives.
Our mission is to bring curative and disease modifying therapies to individuals living with serious chronic conditions. We are a global team with locations in Massachusetts (Greater Boston Research & Early Development Hub), Colorado and Copenhagen, pushing technological innovation to expand the RNA and gene therapy application space. Our proprietary GalXC™ and GalXC-Plus™ RNAi technologies have the potential to address conditions that are difficult or impossible to treat with other modalities. The value chain spans from early research to phase 1 clinical studies.
Established as a Transformational Research Unit (TRU), Global Nucleic Acid Therapies is a unique organization within Novo Nordisk Research & Early Development that brings together the best of both worlds – the agility, collaborative pioneering spirit and calculated risk-taking profile of a biotech along with the scale, resources and capabilities of a global leader in drug development. We are a team of inventive and entrepreneurial thinkers pushing the boundaries of science. Together, we are driving change. Are you ready to make a difference
The Position
The Novo Nordisk GNAT (Global Nucleic Acid Therapies) Early Development Unit is seeking a Medical Doctor with a high degree of scientific acumen, as well as clinical care and drug development experience who is excited by cutting-edge biotechnology and wishes to take part in the unique opportunity to bring highly innovative pharmaceutical products through early clinical development. The candidate is a team player, detail oriented with prior research experience, ideally both in academic medicine and in pharma or biotech.
In this role, the incumbent will assist the team in the GNAT Early Development Unit to advance siRNA oligonucleotide molecules into clinical development. In doing so, they will work across diverse functional teams to plan, design, execute, and analyze early clinical trials, especially first-in-human (FIH) trials. They will be part of a small but dynamic GNAT Medical and Science group, with an emphasis on planning trials that address both initial human safety as well as proof-of-concept that assesses potential efficacy of the drug candidate. The role will entail highly diverse skills, including strategic direction of the GNAT drug candidates, as well as serving as the medical lead for several early development programs. In this high-visibility position, the candidate will be interfacing with both internal and external stakeholders including GNAT and Novo Nordisk senior leadership, external clinical experts, and Principal Investigators.
Relationships
Reports to: Senior Medical Director, GNAT Early Clinical Development.
Work with the Early Development Medical and Science group and the entire GNAT Early Development (ED) team, including the VP of Early Development, GNAT Project Vice-Presidents (PVPs), Program Management, Non-clinical Research, Pharmacology, Toxicology, RNAi Chemistry Manufacturing and Controls (CMC) staff and other functions. Collaborate and interface with relevant functions in the Novo Nordisk US Clinical Development Group, whose functions include Drug Safety, Regulatory Affairs, Clinical Operations, Medical Writing, Biostatistics, Data Management and other functions. Work collaboratively as required with the global Novo Nordisk drug development organization, including the NNI US corporate hub in New Jersey and world headquarters in Denmark.
Essential Functions
Support the Head of GNAT Early Development Program Initiation and Early Clinical Development unit as the US/international clinical lead for several internal GNAT development programs. In this role, the expected interaction will be with both internal and external stakeholders
In conjunction with other relevant functional areas, help develop/refine the strategic and tactical development plans for GNAT siRNA clinical development programs and other emerging novel therapeutics
Provide clinical and scientific expertise in the design of studies, writing of protocols and other study and regulatory-related documents for GNAT early 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 design and execution of clinical trials as chair of each assigned clinical development program’s Medical and Science Team (MST)
Ensure compliance with SOPs, ICH, GCP and other national and international regulatory requirements
Work within the GNAT Early Development Medical and Science group and with GNAT VP Early Development to deliver and drive the timely completion of all clinical activities related to GNAT early clinical development programs
Serve as a leading member or participant in multiple internal review groups and utilize novel and creative methods to resolve clinical development problems
Work with the East Coast Hub and Global Project Teams that are part of the Novo Nordisk organization to deliver excellent medical support to development programs at all stages
Provide support to Regulatory Affairs team members in the compilation of regulatory submissions and the responses to inquiries from US/international regulatory authorities and participate in RA interactions as appropriate
Leverage medical expertise in clinical specialty and subspecialty areas of training to guide and educate GNAT and global Novo Nordisk organization to emerging advances and innovative opportunities in these therapeutic areas
Lend clinical expertise to the Statistical Analysis Plan (SAP) development and data management, and work closely with biostatistics and data management leads in the project team
Act as a liaison between the company and clinical site investigators and KOLs
Collaborate with GNAT Head of Program Initiation and GNAT VP Early Development to support the work of program-level Safety Committees (and Data Safety Monitoring Committees if applicable) before and during clinical trial conduct
Participate in periodic safety review meetings during clinical trial conduct
Participate with other members of the GNAT Early Development Team in reviews of siRNA oligonucleotide targets initiated by GNAT preclinical pharmacology and biology drug discovery scientists. Provide clinical context for the proposed target-indication pairs, allowing insights into pursuit of indications with greatest medical impact and chance of clinical development success
Physical Requirements
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
1+ years of industry or academic clinical research experience including time managing clinical trials is required
Clinical competency based on post-graduate clinical training, as in a residency program 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 preferred
Strong scientific background with experience in reviewing & interpreting scientific and study data is required
Track record of scientific publications strongly preferred
Working knowledge of biostatistics, data management, clinical operations and scientific and technical processes preferred
Working knowledge of applicable US and EU regulatory requirements and of the drug development process required
Experience in building and maintaining effective relationships with external KOL’s, advisory boards and other key external therapeutic area influencers preferred
Proficiency in English required, and ability to converse or understand multiple additional languages 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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.