Sr. Scientist, Toxicology

TL;DR

Sr. Scientist, Toxicology: Supporting nonclinical development and safety assessment across cell and gene therapy programs with an accent on designing, monitoring, interpreting, and reporting toxicology, pharmacology, biodistribution, and pharmacokinetic studies. Focus on integrated toxicology–pharmacology interpretation, CRO study strategy/execution, and preparation of IND/CTA-enabling regulatory documents for FDA/EMA/ICH-aligned submissions.

Location: Somerset, NJ or Philadelphia, PA, United States

Salary: $127,313 - $167,099 USD (base pay)

Company

hirify.global is a global biotechnology company developing advanced cell therapies for life-threatening diseases.

What you will do

• Support toxicology activities for discovery and development-stage cell and gene therapy programs.
• Design, monitor, interpret, and report nonclinical safety, pharmacology, biodistribution, and pharmacokinetic studies.
• Integrate toxicology and pharmacology data to enable candidate selection, risk assessment, and program progression.
• Contribute to study strategy and execution at CROs, including protocol review, monitoring, data interpretation, and final report review.
• Partner with Pharmacology, CMC, Clinical, Regulatory Affairs, and Program Management to advance development programs.
• Support preparation of regulatory documents (e.g., briefing packages, pre-IND/IND submissions) and responses to health authority questions.

Requirements

• Ph.D., DVM, PharmD, or equivalent degree in Toxicology, Pharmacology, Immunology, or a related discipline.
• Minimum 5 years of experience in nonclinical toxicology (or related) within biotechnology or pharmaceutical R&D, with working knowledge of pharmacology principles.
• Working knowledge of GLP toxicology studies, nonclinical pharmacology studies, CRO management, and regulatory expectations for nonclinical development.
• Understanding of FDA, EMA, and ICH regulations for toxicology and cell and gene therapy development.
• Scientific writing, communication, and presentation skills; ability to work independently in a collaborative, matrixed team environment.

Culture & Benefits

• Medical, dental, and vision insurance plus a 401(k) retirement plan with company match.
• Eight (8) weeks of paid parental leave after three (3) months of employment.
• Paid time off including vacation, personal time, sick time, floating holidays, and eleven (11) company holidays.
• Flexible spending and health savings accounts, life and AD&D insurance, and short- and long-term disability coverage.
• Additional voluntary benefits such as commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition.

Hiring process

• Interviews to assess scientific expertise in toxicology/pharmacology and experience with nonclinical study strategy and CRO collaboration.
• Discussion of regulatory submission experience (IND/CTA-enabling packages) and ability to communicate complex nonclinical findings.