Principal Scientist – Toxicology Full-time NEW

Principal Scientist – Toxicology

Facility: Research

Location: Lexington, MA, US

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. Are you ready to make a difference?

The Position

This role is an opportunity to pioneer Novo Nordisk's strategy for small molecule early safety assessment. The position (Principal Scientist) requires a candidate with deep subject matter expertise in exploratory toxicology for small molecules, and an entrepreneurial spirit to work in the company's new and growing small molecule pipeline. In this role the candidate will be working together with experienced colleagues in exploratory and computational toxicology and will, as part of the global team, be responsible for small molecule early safety evaluation based on in vitro/in vivo toxicology screening data to support lead optimization and lead candidate selection. An important part of the role is to guide, manage, and interpret toxicity data performed at contract research organizations (CROs) in close collaboration with project scientists and key program stakeholders/leadership.

The candidate will be part of a subject matter expert team developing Novo Nordisk's strategy for early investigative/exploratory toxicology. The expert team will serve a critical advisory function by communicating evaluations and implications of the strategy across the value chain of Novo Nordisk's small molecule pipeline.

The role requires in-depth understanding of subject matter & relationship to other key areas related to small molecule drug development; expert-level guidance for project team related to experimental strategies to evaluate emerging research and technologies related to small molecules; propose & oversee CROs, external collaborations & strategic partnerships to further develop Novo Nordisk goals related to therapy and/or technology areas, including the use of New Approach Methodologies (NAMs) in toxicology.

Relationships

Reports to the head of Novo Nordisk GDDS Boston toxicology department, co-located with project chemists and ADME scientists, and part of the Novo Nordisk regulatory toxicology team. In addition, important stakeholders will include exploratory toxicologists located in GDDS Denmark, global project managers, non-clinical project managers, scientific leadership, and other colleagues across global R&D. Individual may direct the work of other staff members. Individuals will interact with external research collaborators both academia- & industry-based.

Essential Functions

Initiating, monitoring and reporting Exploratory Toxicology studies/data

Supervise the execution of in silico, in vitro and in vivo toxicology studies at CROs/technology providers to assess safety profiles and progress chemical leads.

Identify and secure optimal exploratory toxicology screening plans in alignment with a cross-functional team including chemists, biologists, and ADME scientists to secure a customized lead optimization process (design, make, test, analyze)

Analyze, interpret and contextualize data to inform safety assessments and decision-making

Lead, support, and develop the Small Molecule Exploratory Toxicology Strategy Implementation in close collaboration with global colleagues

Follow the development of the field of exploratory toxicology at industry peers, CROs and technology providers

Ensure alignment with relevant industry standards, GxP requirements and regulatory standards

Collaborate with cross-functional teams to integrate Exploratory Toxicology strategies into broader drug discovery and development plans

Support Due Diligence (DD) processes

Assess potential assets based on available safety related information and drug-ability and advise decision making based on data and possible follow-up strategies in collaboration with global DD teams

Advisory and Mentorship

Provide expert advisory functions on Exploratory Toxicology/non-clinical safety matters to relevant colleagues and stakeholders

Mentor and guide colleagues in developing their expertise in Exploratory Toxicology/non-clinical safety

Problem Solving and Innovation

Identify and solve complex safety-related challenges using a broad drug discovery and drug development perspective

Recommend innovative solutions and best practices to improve the Exploratory Toxicology/safety evaluation processes

Stay abreast of industry trends and advancements to maintain cutting-edge expertise

Qualifications

Master's degree with 12+ years of relevant experience, or PhD with 8+ years of relevant experience required.

Proven industry expertise in small molecule exploratory toxicology, successfully delivering industry standard clinical candidates based on cross discipline lead optimization.

Medicinal chemistry subject matter expertise is key to assess inherent molecular toxicity risks and to foster close discussion with project chemists

Strong background with in vitro assays and in silico analysis is advantageous

Experience with predictive toxicity SAR tools (e.g. DEREK) is an advantage

Experience working with cross functional teams and proven ability to communicate findings/results to non-SMEs.

Solves complex safety problems with a broad perspective, identifying innovative solutions to promote project progression.

Assess, evaluate and implement new in vitro and in vivo methods relevant for non-clinical safety evaluation/prediction.

Communicates evaluations and implications of non-clinical safety findings effectively.

Acts as a mentor for colleagues, fostering expertise within the organization.

Experience in regulatory toxicology and understanding of ICH guidelines is advantageous.