Sr. Scientific Director, Toxicology
Neurocrine Biosciences
August 14, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About The Role
As a Sr. Leader, leads and executes scientifically sound, regulatory-authority-acceptable toxicology strategies supporting safety assessments for an R&D portfolio from early drug discovery through clinical development and market authorization. Oversees safety pharmacology and toxicology studies (protocol design; execution; data interpretation; report review) for new therapeutic entities across modalities (small molecules, large molecules, peptide conjugates, oligonucleotides, gene therapies). Ensures studies meet applicable guidelines and regulatory test standards (FDA, ICH, WHO, GLP, ISO). Represents Toxicology and partners with R&D to integrate toxicology strategy into development plans and de-risk safety liabilities. Supports in-life resourcing, testing procedure maintenance, program development, performance monitoring, budget planning, and resource management.
Your Contributions (include, but are not limited to)
- Develop, implement, and direct toxicology strategies for R&D safety assessments.
- Plan and execute safety pharmacology and toxicology studies/data.
- Oversee assignments within regulatory toxicology to ensure timely completion.
- Evaluate and summarize safety results; provide strategic direction on program/clinical/regulatory impact.
- Direct preparation of toxicology sections of regulatory documents (INDs, CTAs, BLAs/NDAs/MAAs, briefing books, Investigator’s Brochures).
- Provide strategic oversight for data summaries and result presentations.
- Oversee SOP preparation/adherence and regulatory toxicologist compliance.
- Maintain knowledge of regulatory guidance/industry standards.
- Select, develop, and evaluate personnel in the toxicology group.
- Other tasks as assigned.
Requirements
- PhD in Toxicology, Pathology, or related field + 10+ years pharma/biotech experience (including managing clinical CROs).
- OR D.V.M. + 8+ years similar experience.
- Expert modality knowledge (desired: biotherapeutics incl. bispecific/trispecific antibodies, BBB shuttles, peptide conjugates; oligonucleotides; gene therapies).
- Demonstrated experience preparing INDs, CTAs, BLAs/NDAs/MAAs, briefing books, Investigator’s Brochures.
- Expertise in regulatory strategies (US, Canada, Europe).
- Expert global GLP and Health Authority requirements for nonclinical safety data.
- Extensive experience managing clinical CROs.
- Leadership and ability to influence across organizational levels.
Benefits
- Annual bonus (target 35% of earned base salary); eligibility for equity-based long-term incentive.
- Retirement savings plan (company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision).
Application instructions
- Apply even if your experience/qualifications don’t exactly match the job description.
As a Sr. Leader, leads and executes scientifically sound, regulatory-authority-acceptable toxicology strategies supporting safety assessments for an R&D portfolio from early drug discovery through clinical development and market authorization. Oversees safety pharmacology and toxicology studies (protocol design; execution; data interpretation; report review) for new therapeutic entities across modalities (small molecules, large molecules, peptide conjugates, oligonucleotides, gene therapies). Ensures studies meet applicable guidelines and regulatory test standards (FDA, ICH, WHO, GLP, ISO). Represents Toxicology and partners with R&D to integrate toxicology strategy into development plans and de-risk safety liabilities. Supports in-life resourcing, testing procedure maintenance, program development, performance monitoring, budget planning, and resource management.
Your Contributions (include, but are not limited to)
- Develop, implement, and direct toxicology strategies for R&D safety assessments.
- Plan and execute safety pharmacology and toxicology studies/data.
- Oversee assignments within regulatory toxicology to ensure timely completion.
- Evaluate and summarize safety results; provide strategic direction on program/clinical/regulatory impact.
- Direct preparation of toxicology sections of regulatory documents (INDs, CTAs, BLAs/NDAs/MAAs, briefing books, Investigator’s Brochures).
- Provide strategic oversight for data summaries and result presentations.
- Oversee SOP preparation/adherence and regulatory toxicologist compliance.
- Maintain knowledge of regulatory guidance/industry standards.
- Select, develop, and evaluate personnel in the toxicology group.
- Other tasks as assigned.
Requirements
- PhD in Toxicology, Pathology, or related field + 10+ years pharma/biotech experience (including managing clinical CROs).
- OR D.V.M. + 8+ years similar experience.
- Expert modality knowledge (desired: biotherapeutics incl. bispecific/trispecific antibodies, BBB shuttles, peptide conjugates; oligonucleotides; gene therapies).
- Demonstrated experience preparing INDs, CTAs, BLAs/NDAs/MAAs, briefing books, Investigator’s Brochures.
- Expertise in regulatory strategies (US, Canada, Europe).
- Expert global GLP and Health Authority requirements for nonclinical safety data.
- Extensive experience managing clinical CROs.
- Leadership and ability to influence across organizational levels.
Benefits
- Annual bonus (target 35% of earned base salary); eligibility for equity-based long-term incentive.
- Retirement savings plan (company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision).
Application instructions
- Apply even if your experience/qualifications don’t exactly match the job description.