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Principal Toxicologist

Employer
Novo Nordisk
Location
Lexington, MA
Start date
Feb 6, 2025
View more categoriesView less categories
Discipline
Science/R&D, Toxicology
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Genetown, Best Places to Work

Job Details

About the Department

Dicerna, a Novo Nordisk company, is focused on driving innovation in RNAi (ribonucleic acid interference) to selectively target and silence genes that cause or contribute to disease. Our proprietary GalXC™ and GalXC-Plus™ RNAi technologies have the potential to address conditions that are difficult or impossible to treat with other modalities. Established as a Transformational Research Unit (TRU) following Novo Nordisk’s acquisition of Dicerna Pharmaceuticals, Inc. in December 2021, the Dicerna TRU is a unique new organization within Novo Nordisk 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. With approximately 200 researchers, scientists, drug developers and operational staff, we are a team of inventive and entrepreneurial thinkers pushing the boundaries of science to create and drive new RNAi-based therapies for both rare and more prevalent diseases from the bench to the clinic. Together, we are driving change. Are you ready to make a difference?

 

The Position

We are seeking a Principal Toxicologist to help advance the development of our growing pipeline of product candidates. The individual in this position will be responsible for the design and oversight of toxicology studies conducted internally or externally, interpretation of toxicology data, and writing of regulatory submissions.

 

Relationship

Reports to: Executive Director, Toxicology, Program Development.

 

Essential Functions

  • In conjunction with program teams, design and oversee conduct of external non-GLP investigative or GLP toxicology studies to support novel therapeutic agents through the drug development process
  • Review and provide feedback on related toxicology study protocols and reports
  • Contribute to the writing and preparation of nonclinical components for regulatory submissions
  • Collaborate on design of internal non-GLP investigative toxicity studies in support of development compounds as needed
  • Independently summarize and communicate toxicology data to program teams and executive leadership
  • Communicate toxicology timelines and budgets to stakeholders as needed
  • May monitor CRO toxicology studies
  • Independently manage complete toxicology programs (nonGLP and IND enabling)
  • May participate in CRO evaluation or site visits
  • Collaborate cross functionally with Research, Regulatory, Clinical, and Manufacturing and relevant program teams
  • Some travel may be required depending on project needs
  •  

    Physical Requirements

    Approximately 0-10% overnight travel. Ability to lift 0-10 lbs.

     

    Qualifications

  • Ph.D in a scientific discipline with 4+ years or Master’s degree in a scientific discipline with 8+ years of relevant pharmaceutical industry experience required. Degree in a toxicology-related discipline is preferred
  • Experience as a toxicologist supporting drug development programs required
  • Experience with oligonucleotides preferred
  • Knowledge of global regulatory guidances (e.g. ICH and geography-specific) and Good Laboratory Practice (GLP) standards required
  • Strong attention to detail, ability to critically evaluate all study documentation (eg. protocols, data, reports) required
  • Ability to critically evaluate written toxicology documents for overall quality and acceptability of scientific interpretation required
  • Effective organization skills and ability to work in a multi-tasking, fast-paced environment required
  • Experience in developing toxicology programs to support early and later stage drug development and in preparing regulatory filings such as INDs/CTAs. Experience in conduction GLP repeat-dose, reproductive, and genetic toxicology studies is preferred
  • Goal oriented, highly self-motivated and self-directing individual who enjoys working in different environments and multiple capacities preferred
  • Ability to work well in a team setting/matrix-type organization and to build strong cross-functional relationships preferred
  • Enthusiasm for meeting program timelines and goals preferred
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    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.

    Company

    Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

    Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by 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. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

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    Company info
    Website
    Phone
    617-612-6200
    Location
    75 Hayden Avenue
    Lexington
    MA
    02421
    United States

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