Senior Scientist, Safety Assessment, Investigative Toxicology

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Lead the architectural design and implementation of data models that transform multi-dose toxicology data, clinical pathology tables, and safety pharmacology metrics into visually engaging, publication-ready tools.

• Develop exposure-margin heatmaps, benchmark dose plots, cumulative trend diagnostics, and other analyses to delineate therapeutic windows.

• Supervise the review and quality assurance of incoming regulatory SEND datasets from CRO vendors.

• Ensure compliance of SEND datasets, conduct schema validation, and align with finalized nonclinical study reports prior to regulatory submission and archiving.

• Perform scientific literature reviews to evaluate target-mediated and chemotype-specific safety risks.

• Integrate ambiguous biological data into technical memoranda that guide investigative toxicity strategies.

• Collaborate with Toxicology Leads to co-author data packages, briefing documents, and executive presentations.

• Advocate for safety strategies and secure program endorsements within Project Development Teams and internal governance committees.

• Coordinate with Safety Assessment, CMC, DMPK, and Project Management to ensure nonclinical safety deliverables are aligned with global project timelines.

• Act as a scientific and strategic hub, connecting internal toxicology leaders with Project Development Teams and related disciplines.

⛳️ Requirements

• B.S. or M.S. degree in Toxicology, Pharmacology, Cellular/Molecular Biology, Bioinformatics, or a comparable life sciences field.

• For candidates with an M.S. degree: 6–8+ years of directly relevant experience in biotechnology, pharmaceuticals, or tier-one CRO industries.

• For candidates with a B.S. degree: 8–10+ years of significant experience in industrial drug development, data management, and toxicology operations.

• In-depth understanding of preclinical toxicology datasets, histopathology reporting frameworks, and study designs.

• Practical experience in auditing, validating, or working directly with regulatory SEND data formats.

• Advanced skills in utilizing scientific data software to create complex data structures, including GraphPad Prism, Spotfire, Excel macros, or specialized Python/R data visualization tools.

• Excellent technical writing capabilities.

• Proven ability to convert complex data into clear, persuasive arguments for a variety of cross-functional scientific leaders.

• A strong sense of curiosity, adaptability, problem-solving skills, and a readiness to explore artificial intelligence and digital technologies.

🏝️ Benefits

• Company bonus based partially on company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, including an employee assistance program, fitness benefits, and involvement in employee clubs and activities.

• Access to employee resource groups and support networks.