Senior Scientist II - Non-clinical Safety

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, analyses 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 summarize non-clinical safety studies
    • Ensure the application of best practices and innovative approaches to improve study outcomes
  • Analyze and Report Safety Findings
    • Analyze data from in vitro and in vivo safety evaluations to assess the safety-related effects of biological and chemical entities
    • Prepare comprehensive reports of findings and communicate evaluations and implications to relevant stakeholders
    • Provide expert advisory functions on non-clinical safety findings to support decision-making processes
  • Regulatory Submission Preparation
    • Prepare and review non-clinical safety sections of regulatory submissions, ensuring compliance with relevant guidelines
    • Collaborate with cross-functional teams to integrate safety data into regulatory documents
    • Act as a subject matter expert in discussions with regulatory authorities regarding non-clinical safety data
  • Strategic Improvement and Innovation
  • Utilize in-depth knowledge and experience to identify opportunities for process improvements and innovation in non-clinical safety evaluations
  • Implement strategies to enhance the efficiency and effectiveness of safety studies and reporting
  • Stay abreast of industry trends and advancements to maintain a competitive edge in non-clinical safety practices

Qualifications

• BS/BA with 12+ years of relevant experience; or master’s degree with 10+ years of relevant experience; or PhD with 6+ years’ of relevant experience required
• Demonstrates subject matter expertise in non-clinical safety evaluation
• Applies solid knowledge and skills relevant for cross-functional understanding within the business
• Uses best practices and knowledge of internal or external business issues to improve products or services
• Works independently with minimal guidance, handling specialist tasks of high complexity
• Analyzes and prepares reporting of findings, performing advisory functions and communicating evaluations
• Prepares and reviews non-clinical safety sections of regulatory submissions
• Designs and improves in vitro and in vivo methods for non-clinical safety evaluation

The base compensation range for this position is $150,000 to $190,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

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.