Director Toxicology

Location: Remote/Home-Based roles available in Mississauga, Canada; London, UK; or California, United States

Salary: $204,000–$306,000 USD base pay annually for US-based candidates, plus potential bonus, equity, and benefits.

Company

hirify.global is a global biopharmaceutical company developing medicines for serious diseases, with a focus on sleep disorders, epilepsy, oncology, and neuroscience.

What you will do

• Lead global nonclinical regulatory and investigative toxicology for assigned pharmaceutical products.
• Design, oversee, and finalize GLP and non-GLP toxicology studies conducted by external CROs.
• Review toxicology reports, interpret multidisciplinary data, and define PK/PD and PK/toxicity correlations.
• Draft nonclinical sections for IND, CTA, NDA, BLA, and related regulatory submissions.
• Represent Toxicology on early development and cross-functional teams, identifying risks and developing mitigation strategies.
• Provide toxicology expertise to Regulatory, Quality, Clinical, CMC, Drug Safety, Medical Affairs, and external collaborators.

Requirements

• Ph.D. in Toxicology, Pharmacology, Pathology, Biochemistry, Biology, or a related field, with extensive pharmaceutical drug development experience.
• Extensive experience with small and large molecules; oncology and CNS experience is preferred.
• Experience managing CROs, outsourcing toxicology studies, and reviewing study data and reports.
• Strong knowledge of FDA, EMA, ICH guidance, and GLP regulations.
• Experience authoring nonclinical sections of IND, CTA, BLA, NDA, or sNDA submissions and responding to regulatory questions.
• Excellent scientific writing, communication, data interpretation, and cross-functional collaboration skills.

Nice to have

• Board certification such as DABT or ERT, or board eligibility with plans to take the examination.
• Experience in Discovery Toxicology and early-stage, non-IND-enabling development.

Culture & Benefits

• Fast-paced, hands-on, and highly collaborative scientific environment.
• Opportunity to contribute to innovative drug discovery and development programs.
• US-based employees may receive medical, dental, vision, 401(k), and paid vacation benefits.
• Potential eligibility for annual cash bonus or incentive compensation and discretionary equity grants.