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 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 and in-depth knowledge and experience. Works independently; receives minimal guidance. Acts as a resource for colleagues with less experience;

may direct the work of other staff members.

• Lead multiple projects as subject‑matter expert and function as project leader for projects comprising multiple experimental activities, coordinating activities to meet deadlines, communicating project updates and experimental results, providing expert‑level guidance to experimental plans and data interpretation; may propose and lead external research efforts to support project goals; attend and present at scientific conferences; deepen understanding of subject matter and demonstrate creative solutions for addressing critical scientific questions;
  
  may supervise junior staff; author internal reports and external publications; recommend, present, and champion new targets or methodologies.
• 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 subject‑matter expert in discussions with regulatory authorities regarding non‑clinical safety data.
• Utilize in‑depth knowledge 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.

Reports to the head of the relevant department. Internal relationships include working closely with technical staff and other members of the…