Distinguished Scientist, Safety Assessment Project Expert (Toxicology)

Location: Cambridge, MA, United States; onsite

Salary: $178,500–$257,833 per year

Company

hirify.global is a global healthcare company developing medicines and advancing drug discovery and development.

What you will do

• Oversee nonclinical safety programs for R&D drug candidates across small molecules, biotherapeutics, oligonucleotides, and other modalities.
• Develop and implement toxicology and safety pharmacology strategies for early- and late-stage development and marketed products.
• Prepare and review nonclinical summaries for Investigator Brochures, INDs, CTAs, NDAs/BLAs, Pediatric Investigation Plans, and other regulatory documents.
• Review internal and external study reports and ensure high scientific standards in nonclinical safety and investigative toxicology studies.
• Provide expertise on global nonclinical safety issues, in-licensing opportunities, scientific publications, presentations, and special projects.
• Collaborate with multifunctional R&D project teams, internal functions, external laboratories, and global regulatory agencies.

Requirements

• PhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, pathology, statistics, or a related field.
• 12+ years of pharmaceutical industry experience.
• Knowledge of GLP and ICH policies and regulatory nonclinical testing requirements.
• Experience preparing and submitting IND and CTD submissions.
• English required.
• Excellent presentation and writing skills.

Nice to have

• Experience as a GLP Study Director.
• Experience conducting and interpreting ophthalmology toxicity studies and data.
• Experience with reproductive and developmental toxicity studies and data.
• American Board of Toxicology certification.

Culture & Benefits

• Work alongside a supportive, future-focused team on innovative drug development.
• Participate in global, multifunctional project teams.
• Career growth opportunities through promotion or lateral moves.
• Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Rewards and compensation package tied to contribution and experience.