Sr. Scientific Director, Toxicology
Neurocrine Biosciences
July 02, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About The Role
As a Sr. Leader, leads and executes scientifically sound and regulatory authority-acceptable toxicology strategies supporting safety assessments across an R&D portfolio from early discovery through clinical development and market authorization.
Your Contributions (include, but are not limited to)
- Develop, implement, and direct toxicology strategies for safety assessments across R&D.
- Plan and support Safety Pharmacology and Toxicology studies/data for all programs.
- Oversee and direct regulatory toxicology assignments to ensure timely completion.
- Evaluate, interpret, and summarize safety pharmacology/toxicology results; provide strategic direction on program and clinical/regulatory impact.
- Advise and direct Safety Pharmacology and Toxicology sections of regulatory documents (INDs, CTAs, BLAs/NDAs/MAAs, briefing books, Investigator’s Brochures, etc.).
- Integrate toxicology strategies into R&D plans to de-risk safety liabilities.
- Provide oversight for data summaries and presentation of results.
- Oversee preparation of SOPs and ensure functional adherence; ensure toxicologists follow Toxicology SOPs.
- Maintain knowledge of regulatory guidance and industry standards; select/develop/evaluate toxicology personnel.
- Other tasks as assigned.
Requirements
- PhD in Toxicology, Pathology, or closely related + 10+ years pharma/biotech experience, including managing clinical CROs.
- Or D.V.M. + 8+ years similar experience.
- Expert modality knowledge (biotherapeutics such as bispecific/trispecific antibodies, BBB shuttles, peptide conjugates; oligonucleotides; gene therapies—desired).
- Experience preparing INDs/CTAs/BLAs/NDAs/MAAs, briefing books, and Investigator’s Brochures.
- Expert global regulatory strategies (US, Canada, Europe) and global GLP/health authority requirements for nonclinical safety data.
- Extensive clinical CRO management experience.
- Proven leadership and ability to influence across the organization; ability to serve as advisor/emerging expert.
Benefits
- Annual bonus target 35% of earned base salary; eligibility for equity long-term incentive.
- Retirement plan (company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision).
As a Sr. Leader, leads and executes scientifically sound and regulatory authority-acceptable toxicology strategies supporting safety assessments across an R&D portfolio from early discovery through clinical development and market authorization.
Your Contributions (include, but are not limited to)
- Develop, implement, and direct toxicology strategies for safety assessments across R&D.
- Plan and support Safety Pharmacology and Toxicology studies/data for all programs.
- Oversee and direct regulatory toxicology assignments to ensure timely completion.
- Evaluate, interpret, and summarize safety pharmacology/toxicology results; provide strategic direction on program and clinical/regulatory impact.
- Advise and direct Safety Pharmacology and Toxicology sections of regulatory documents (INDs, CTAs, BLAs/NDAs/MAAs, briefing books, Investigator’s Brochures, etc.).
- Integrate toxicology strategies into R&D plans to de-risk safety liabilities.
- Provide oversight for data summaries and presentation of results.
- Oversee preparation of SOPs and ensure functional adherence; ensure toxicologists follow Toxicology SOPs.
- Maintain knowledge of regulatory guidance and industry standards; select/develop/evaluate toxicology personnel.
- Other tasks as assigned.
Requirements
- PhD in Toxicology, Pathology, or closely related + 10+ years pharma/biotech experience, including managing clinical CROs.
- Or D.V.M. + 8+ years similar experience.
- Expert modality knowledge (biotherapeutics such as bispecific/trispecific antibodies, BBB shuttles, peptide conjugates; oligonucleotides; gene therapies—desired).
- Experience preparing INDs/CTAs/BLAs/NDAs/MAAs, briefing books, and Investigator’s Brochures.
- Expert global regulatory strategies (US, Canada, Europe) and global GLP/health authority requirements for nonclinical safety data.
- Extensive clinical CRO management experience.
- Proven leadership and ability to influence across the organization; ability to serve as advisor/emerging expert.
Benefits
- Annual bonus target 35% of earned base salary; eligibility for equity long-term incentive.
- Retirement plan (company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision).