Sr. Scientific Director, Toxicology
Neurocrine Biosciences
2 months ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About The Role
- Lead and execute 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.
- Recommend longer-term strategies to achieve strategic and operational objectives.
- Oversee safety pharmacology and toxicology studies (protocol design; direct execution; interpret/review reports) for modalities including small molecules, large molecules, peptide conjugates, oligonucleotides, and gene therapies.
- Ensure toxicology studies/programs follow applicable guidelines and regulatory test standards (FDA, ICH, WHO, GLP, ISO).
- Represent Toxicology and collaborate with R&D to integrate toxicology strategy into the development plan, provide safety-profile insight, and de-risk safety liabilities.
- Support in-life resource planning, testing procedures, program development, performance monitoring, and budget/resource management.
Your Contributions (include, but are not limited to)
- Develop, implement, and direct toxicology strategies for R&D safety assessments.
- Support planning/execution of safety pharmacology and toxicology studies/data for all programs.
- Oversee assignments within the regulatory toxicology function to ensure timely completion of priority activities.
- Evaluate, interpret, and summarize results; provide strategic direction to project teams/senior management.
- Advise/direct preparation of toxicology sections of regulatory documents (INDs, CTAs, BLAs/NDAs/MAAs, briefing books, Investigator’s Brochures, etc.).
- Provide strategic oversight for data summaries and contribute to presenting results to peers and management.
- Oversee SOP preparation and adherence; ensure regulatory toxicologists follow all Toxicology SOPs.
- Maintain current knowledge of regulatory guidance and industry standards.
- Participate in selecting, developing, and evaluating personnel in the toxicology group.
Requirements
- PhD in Toxicology, Pathology, or closely related discipline + 10+ years pharmaceutical/biotech experience, including managing clinical Contract Research Organizations (CROs).
- D.V.M. + 8+ years of similar experience.
- Expert knowledge in development of biotherapeutics (e.g., bispecific/trispecific antibodies, BBB shuttles, peptide conjugates), oligonucleotides, and gene therapies (desired).
- Demonstrated experience preparing INDs, CTAs, BLAs/NDAs/MAAs, briefing books, and Investigator’s Brochures.
- Expert regulatory strategies for various modalities in US, Canada, and Europe.
- Ability to develop and implement strategy within areas of responsibility.
- Expert knowledge of global GLP and Health Authority requirements for nonclinical safety data supporting clinical trials and market authorization.
- Extensive experience managing clinical CROs.
- Ability to become a company-wide advisor/emerging industry expert.
- Demonstrated leadership skills and ability to influence across organizational levels.
Benefits
- Annual bonus (target 35% of earned base salary) and eligibility for equity-based long-term incentive program.
- Retirement savings plan (with company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and medical/prescription drug/dental/vision coverage.
Application Instructions
- Encouraged to apply even if experience/qualifications don’t exactly match the job description.
- Lead and execute 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.
- Recommend longer-term strategies to achieve strategic and operational objectives.
- Oversee safety pharmacology and toxicology studies (protocol design; direct execution; interpret/review reports) for modalities including small molecules, large molecules, peptide conjugates, oligonucleotides, and gene therapies.
- Ensure toxicology studies/programs follow applicable guidelines and regulatory test standards (FDA, ICH, WHO, GLP, ISO).
- Represent Toxicology and collaborate with R&D to integrate toxicology strategy into the development plan, provide safety-profile insight, and de-risk safety liabilities.
- Support in-life resource planning, testing procedures, program development, performance monitoring, and budget/resource management.
Your Contributions (include, but are not limited to)
- Develop, implement, and direct toxicology strategies for R&D safety assessments.
- Support planning/execution of safety pharmacology and toxicology studies/data for all programs.
- Oversee assignments within the regulatory toxicology function to ensure timely completion of priority activities.
- Evaluate, interpret, and summarize results; provide strategic direction to project teams/senior management.
- Advise/direct preparation of toxicology sections of regulatory documents (INDs, CTAs, BLAs/NDAs/MAAs, briefing books, Investigator’s Brochures, etc.).
- Provide strategic oversight for data summaries and contribute to presenting results to peers and management.
- Oversee SOP preparation and adherence; ensure regulatory toxicologists follow all Toxicology SOPs.
- Maintain current knowledge of regulatory guidance and industry standards.
- Participate in selecting, developing, and evaluating personnel in the toxicology group.
Requirements
- PhD in Toxicology, Pathology, or closely related discipline + 10+ years pharmaceutical/biotech experience, including managing clinical Contract Research Organizations (CROs).
- D.V.M. + 8+ years of similar experience.
- Expert knowledge in development of biotherapeutics (e.g., bispecific/trispecific antibodies, BBB shuttles, peptide conjugates), oligonucleotides, and gene therapies (desired).
- Demonstrated experience preparing INDs, CTAs, BLAs/NDAs/MAAs, briefing books, and Investigator’s Brochures.
- Expert regulatory strategies for various modalities in US, Canada, and Europe.
- Ability to develop and implement strategy within areas of responsibility.
- Expert knowledge of global GLP and Health Authority requirements for nonclinical safety data supporting clinical trials and market authorization.
- Extensive experience managing clinical CROs.
- Ability to become a company-wide advisor/emerging industry expert.
- Demonstrated leadership skills and ability to influence across organizational levels.
Benefits
- Annual bonus (target 35% of earned base salary) and eligibility for equity-based long-term incentive program.
- Retirement savings plan (with company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and medical/prescription drug/dental/vision coverage.
Application Instructions
- Encouraged to apply even if experience/qualifications don’t exactly match the job description.