Senior Scientist II - Non-clinical Safety

Senior Scientist II - Non-clinical Safety

Facility:
Research

Location:

Lexington, MA, US

About the Department

Our Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown, Cambridge and Plainsboro 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 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 Senior Scientist II will be responsible for strategy implementation and operations for conducting and summarizing non‑clinical safety studies internally and externally on new drug substances. Designs toxicology, safety pharmacology and toxico‑pathological investigations in line with relevant GxP requirements in non‑clinical development programs. Studies the safety‑related effects of biological and chemical entities in in vitro systems and animals and conducts non‑clinical safety investigations on experimental drugs and other substances relevant to drug development.

Develops and improves in vitro and in vivo methods for non‑clinical safety evaluation, analyzes and prepares reporting of findings, performs advisory functions and communicates evaluations and implications of non‑clinical safety findings. Prepares and reviews non‑clinical safety sections of regulatory submissions as relevant.

Demonstrates subject matter expertise. Requires in-depth knowledge and experience. Solid knowledge and skills relevant for NN Business cross‑functional understanding. Strong knowledge within a specific process and extensive business understanding across SVP area. Uses best practices and knowledge of internal or external business issues to improve products or services. Works independently; receives minimal guidance. Acts as a resource for colleagues with less experience;

may direct the work of other staff members. Perceived as expert within one or several key processes across the VP/CVP area. Handling specialist tasks of high complexity critical to the CVP area.

Lead multiple projects as subject matter expert, function as project leader for projects comprising multiple experimental activities & coordination of activities to meet deadlines, communicate project updates & experimental results, provide expert‑level guidance to experimental plans & data interpretation; may propose & lead external research efforts to support project goals; attend & present at scientific conferences as an NN‑subject matter expert;

deep understanding of subject matter & demonstrate creative thinking & solutions for addressing critical scientific questions; may supervise junior staff; author internal reports & external publications; recommend, present, & champion new targets or methodologies. Demonstrated ability to map out long‑term work plan to address gaps with an understanding of the bigger picture of drug development & needs within a therapeutic area or target biology space.

May mentor or directly supervise less experienced team members based on business need, skill, and/or interest.

Relationships

Reports to the head of the relevant department at Novo Nordisk. Internal relationships include working closely with technical staff & other members of the scientific leadership team; regular collaborations with members of other research departments at Novo Nordisk; & frequent interaction with project managers & other colleagues across global R&D. Individual may direct the work of other staff members. Individual will interact with external research collaborators both academia‑ & industry‑based.

Essential Functions

• Lead Non‑Clinical Safety Studies
  • Design and oversee toxicology studies in line with GxP requirements (including clinical pharmacology, safety pharmacology, and histopathological endpoints)
  • Conduct and…