Associate Director Toxicology
Acadia Pharmaceuticals
9 hours ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary
Associate Director (Translational Science) overseeing preclinical safety assessment/toxicology deliverables. Hybrid role (San Diego, CA; San Francisco, CA; or Princeton, NJ) requiring ~3 days/week in office.
Primary Responsibilities
- Plan and design preclinical safety/t toxicology programs (design, logistics, resourcing, schedules) and identify critical support needs.
- Provide scientific oversight from lead optimization through IND/NDA and nonclinical post-marketing approval requirements.
- Monitor CROs for quality/compliance and manage vendors/consultants (study design, execution coordination, quality, scientific rigor).
- Review and contribute to toxicology reports; oversee test compound delivery, shipment, and supply.
- Work cross-functionally, coordinate as needed, proactively communicate status/issues, and guide teams to resolve study/project issues.
Qualifications
- BS or MS in a relevant field.
- Target 8 years’ relevant experience in preclinical safety/t toxicology for drug development (pharma/biotech).
- DABT certification strongly preferred (or equivalent education/experience).
Key Skills/Knowledge
- Preclinical safety/t toxicology strategy execution; experimental/statistical tools; instrumentation.
- Knowledge of study types: acute/chronic toxicology, safety pharmacology, DART, genotoxicity, carcinogenicity.
- GLP study monitoring experience at CROs; report composition/review for accuracy/quality/compliance.
- Knowledge of GLP, ICH, FDA guidance, and regulations.
- Strong communication, influencing/problem-solving, collaboration in cross-functional/semi-virtual teams; willingness to travel.
Benefits (US-based employees)
Medical/dental/vision; employer-paid life/disability/travel/EAP; 401(k) match (1:1 up to 5%); equity/bonus; stock purchase plan; 15+ vacation days; paid holidays; paid sick time; paid parental leave; tuition assistance.
Associate Director (Translational Science) overseeing preclinical safety assessment/toxicology deliverables. Hybrid role (San Diego, CA; San Francisco, CA; or Princeton, NJ) requiring ~3 days/week in office.
Primary Responsibilities
- Plan and design preclinical safety/t toxicology programs (design, logistics, resourcing, schedules) and identify critical support needs.
- Provide scientific oversight from lead optimization through IND/NDA and nonclinical post-marketing approval requirements.
- Monitor CROs for quality/compliance and manage vendors/consultants (study design, execution coordination, quality, scientific rigor).
- Review and contribute to toxicology reports; oversee test compound delivery, shipment, and supply.
- Work cross-functionally, coordinate as needed, proactively communicate status/issues, and guide teams to resolve study/project issues.
Qualifications
- BS or MS in a relevant field.
- Target 8 years’ relevant experience in preclinical safety/t toxicology for drug development (pharma/biotech).
- DABT certification strongly preferred (or equivalent education/experience).
Key Skills/Knowledge
- Preclinical safety/t toxicology strategy execution; experimental/statistical tools; instrumentation.
- Knowledge of study types: acute/chronic toxicology, safety pharmacology, DART, genotoxicity, carcinogenicity.
- GLP study monitoring experience at CROs; report composition/review for accuracy/quality/compliance.
- Knowledge of GLP, ICH, FDA guidance, and regulations.
- Strong communication, influencing/problem-solving, collaboration in cross-functional/semi-virtual teams; willingness to travel.
Benefits (US-based employees)
Medical/dental/vision; employer-paid life/disability/travel/EAP; 401(k) match (1:1 up to 5%); equity/bonus; stock purchase plan; 15+ vacation days; paid holidays; paid sick time; paid parental leave; tuition assistance.