Scientific Director (Toxicology)

Location: US - California - Thousand Oaks; hybrid, with remote work potentially available

Salary: $211,407.75–$286,022.25 annually

Company

hirify.global is a biotechnology company developing and manufacturing medicines across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead the Product Stewardship Toxicology function within the Environment, Health, Safety & Sustainability organization.
• Develop toxicology strategies supporting global product development, commercialization, and lifecycle management.
• Direct extractables and leachables, packaging, manufacturing materials, impurities, and product quality risk assessments.
• Lead occupational toxicology activities, including OEB classifications, OEL derivation, hazard assessment monographs, and worker health risk assessments.
• Provide toxicology expertise for medical devices and combination products, including ISO 10993 biological evaluations.
• Lead cross-functional scientific programs, mentor talent, monitor emerging regulatory expectations, and represent hirify.global in external scientific organizations.

Requirements

• PhD, PharmD, or MD with 5 years of directly related experience; or a master’s degree with 8 years; or a bachelor’s degree with 10 years.
• Significant pharmaceutical or biotechnology industry experience and deep expertise in occupational and pharmaceutical toxicology.
• Experience deriving Occupational Exposure Limits and Occupational Exposure Bands and conducting worker safety risk assessments.
• Extensive knowledge of extractables and leachables, chemical characterization, CMC, product quality, and manufacturing risk assessment.
• Experience with medical devices and combination products under ISO 10993 and with regulatory frameworks including ICH, ISO, PQRI, and BPOG.
• Strong scientific writing, technical communication, stakeholder influence, project leadership, and operational excellence skills.

Nice to have

• DABT, ERT, or equivalent professional certification.
• Experience with PDEs, TTC, ICH M7, Cramer TTC, OECD Toolbox, Toxtree, and Benchmark Dose software.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Comprehensive medical, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions and stock-based long-term incentives.
• Discretionary annual bonus program and award-winning time-off plans.
• Flexible work models where applicable, along with career development opportunities.

Hiring process

• Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
• Sponsorship for the role is not guaranteed.