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 team is comprised of collaborative, diverse and passionate people who have a true sense of pride in their work and are committed to helping others grow and develop their careers. You’ll also have a platform to engage with key stakeholders on a global scale throughout the entire pipeline process. And while changing the future of diabetes, obesity and MASH treatment is no easy task, we also recognize the importance of an enjoyable workplace, which is why we’ve cultivated a culture of fun, ingenuity and innovation. And our competitive compensation package and support of a healthy work-life balance all add to a best-in-class employee experience. We are changing lives for a living. Are you ready to make a difference?

The Position

The Senior Scientist for Bioanalytical Sciences Outsourcing will work in a multi-disciplinary department within Novo Nordisk that manages multiple nonclinical, and early-stage clinical programs based on an innovative RNAi technology platform. The Senior Scientist will be responsible for managing the outsourcing of PK, biomarker and ADA assays to Contract Research Organizations (CROs) and serve as the team's bioanalytical assays subject matter expert.

Relationships

Reports to head of siRNA Nonclinical Development, is an individual contributor and does not have any direct or Indirect reports.

Works: Extensively with external vendors/CROs, Daily with various internal subject matter experts in the department. With Nonclinical and Clinical Assay Science (NCAS) colleagues in Denmark.

Essential Functions

• Bioanalytical Assay Outsourcing Management:
  • Ensure outsourcing of our PK, biomarker and ADA assays to Contract Research Organizations (CROs)
  • Identification of suitable CROs
  • Setting up contracts for validation of assays
  • Supporting nonclinical studies and trial sample analysis and ensuring transfer and cross-validation of assays from Novo Nordisk to the CROs
  • Serve as a subject matter expert in the application of bioanalytical assays (LC-MS, MSD, ELISA, qPCR, cell-based assays) to support PK, biomarker and immunogenicity objectives in nonclinical and clinical studies
  • Take part in routine vendor meetings, supply critical reagents, assess study plans, negotiate data transfer agreements, and review data and reports
  • Engage in the creation and review of regulatory paperwork for commencing clinical trials (e.g., IND and CTA) and obtaining drug approvals (e.g., NDA and MAA)
  • Attend program team meetings, acting as a cooperative and dependable bioanalytical representative and team member, to ensure study timelines are met and to advance programs
    • ​​​​​​​Communicate effectively across all organizational levels, functions, and cultures

Physical Requirements

Less than 10% overnight travel required.

Qualifications

• Master’s degree with at least 8 years relevant academic or industry experience or PhD with 4 years relevant industry or post-doctorate experience can be considered; BS/BA and At least 10 years relevant technical experience required.
  • ​​​​​​​It is preferred that qualified candidates will hold at least a Masters’ degree within Life Science (e.g., Biology, Human Biology, Biochemistry, Pharmacy, Biotech Engineering etc.) and a minimum of at least 8+ years of bioanalytical assays experience in the pharmaceutical industry, working with development and validation of bioanalytical methods (such as immunoassays (ELISA, RIA, MSD, AlphaLISA) and chromatography-based assays (LC-MS/MS, HPLC)
• Experience with nonclinical and clinical development outsourcing management, knowledge of the regulatory guidelines and the GLP/GCP principles
• Ability to deal with multiple priorities with aggressive deadlines
• Demonstrates excellent verbal and written communication skills, with an emphasis on presentation abilities
• Experience with nucleic acids (e.g., siRNA, ASO, gene therapy) preferred

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.