Scientific Director
Amgen
August 07, 2026
Remote friendly (Thousand Oaks, CA)
United States
Clinical Research and Development
Scientific Director, Product Stewardship Toxicology
What You Will Do
- Provide scientific and strategic leadership for Product Stewardship within EHSS.
- Lead a specialized toxicology function supporting development, commercialization, and lifecycle management while ensuring patient safety, worker safety, and regulatory compliance.
- Build and continuously improve toxicology programs supporting the product portfolio from early development through post-market lifecycle management.
- Hybrid role; remote work option may be available.
Key Responsibilities
- Strategic Leadership: Lead EHSS Product Stewardship Toxicology; develop global toxicology strategies; provide scientific leadership across Product Development, Process Development, Quality, Manufacturing, Medical Device Engineering, Regulatory Affairs, and EHSS; influence enterprise decisions via toxicological risk assessment; improve toxicology processes, standards, and governance.
- Product Quality & CMC Toxicology: Lead E&L assessments, single-use systems, primary packaging, container closure systems, drug delivery devices, and combination products; support quality investigations/non-conformances/complaints; develop risk assessments for regulatory submissions and quality decisions; evaluate process-related impurities, reagents, excipients, and materials.
- Occupational Toxicology Leadership: Lead occupational toxicology strategy; perform/oversee OEB classifications; derive OELs; author/approve Hazard Assessment Monographs; conduct worker health risk assessments; support industrial hygiene; provide GHS hazard classifications for SDSs/labeling.
- Medical Device & Combination Product Support: Support ISO 10993 evaluations (including ISO 10993-17); partner with device engineering for submissions.
- External Scientific Leadership: Monitor emerging science/regulatory expectations; represent Amgen externally; influence standards/initiatives (ICH M7, PQRI, BPOG, ISO, EU GMP, occupational toxicology guidance).
- Program Leadership: Lead cross-functional projects; mentor/develop scientific talent; drive operational excellence and knowledge management.
What We Expect Of You
Basic Qualifications:
- PhD/PharmD/MD (with relevant post-doc where applicable) + 5 years directly related experience OR
- Master’s + 8 years directly related experience OR
- Bachelor’s + 10 years directly related experience.
Preferred Qualifications/Skills:
- PhD or MS in Toxicology, Pharmacology, or related life science.
- DABT/ERT or equivalent.
- Pharmaceutical/biotech experience; occupational toxicology expertise (OELs/OEBs); toxicology risk assessments for manufacturing/worker safety.
- Extractables & leachables knowledge and toxicological evaluation.
- CMC/product quality risk assessment; ISO 10993 medical device/combination product experience.
- Regulatory knowledge (ICH/ISO/PQRI/BPOG and global regulations).
- Threshold expertise (PDEs, TTC, ICH M7, Cramer TTC); toxicology databases/tools (OECD Toolbox, Toxtree, Benchmark Dose).
- Strong scientific writing/communication/presentation; influence senior stakeholders; lead complex scientific programs/change; project management/operational excellence.
Application Instructions
- Apply now via careers.amgen.com.
- No application deadline; applications accepted until sufficient candidates or selection.
- Sponsorship not guaranteed.
What You Will Do
- Provide scientific and strategic leadership for Product Stewardship within EHSS.
- Lead a specialized toxicology function supporting development, commercialization, and lifecycle management while ensuring patient safety, worker safety, and regulatory compliance.
- Build and continuously improve toxicology programs supporting the product portfolio from early development through post-market lifecycle management.
- Hybrid role; remote work option may be available.
Key Responsibilities
- Strategic Leadership: Lead EHSS Product Stewardship Toxicology; develop global toxicology strategies; provide scientific leadership across Product Development, Process Development, Quality, Manufacturing, Medical Device Engineering, Regulatory Affairs, and EHSS; influence enterprise decisions via toxicological risk assessment; improve toxicology processes, standards, and governance.
- Product Quality & CMC Toxicology: Lead E&L assessments, single-use systems, primary packaging, container closure systems, drug delivery devices, and combination products; support quality investigations/non-conformances/complaints; develop risk assessments for regulatory submissions and quality decisions; evaluate process-related impurities, reagents, excipients, and materials.
- Occupational Toxicology Leadership: Lead occupational toxicology strategy; perform/oversee OEB classifications; derive OELs; author/approve Hazard Assessment Monographs; conduct worker health risk assessments; support industrial hygiene; provide GHS hazard classifications for SDSs/labeling.
- Medical Device & Combination Product Support: Support ISO 10993 evaluations (including ISO 10993-17); partner with device engineering for submissions.
- External Scientific Leadership: Monitor emerging science/regulatory expectations; represent Amgen externally; influence standards/initiatives (ICH M7, PQRI, BPOG, ISO, EU GMP, occupational toxicology guidance).
- Program Leadership: Lead cross-functional projects; mentor/develop scientific talent; drive operational excellence and knowledge management.
What We Expect Of You
Basic Qualifications:
- PhD/PharmD/MD (with relevant post-doc where applicable) + 5 years directly related experience OR
- Master’s + 8 years directly related experience OR
- Bachelor’s + 10 years directly related experience.
Preferred Qualifications/Skills:
- PhD or MS in Toxicology, Pharmacology, or related life science.
- DABT/ERT or equivalent.
- Pharmaceutical/biotech experience; occupational toxicology expertise (OELs/OEBs); toxicology risk assessments for manufacturing/worker safety.
- Extractables & leachables knowledge and toxicological evaluation.
- CMC/product quality risk assessment; ISO 10993 medical device/combination product experience.
- Regulatory knowledge (ICH/ISO/PQRI/BPOG and global regulations).
- Threshold expertise (PDEs, TTC, ICH M7, Cramer TTC); toxicology databases/tools (OECD Toolbox, Toxtree, Benchmark Dose).
- Strong scientific writing/communication/presentation; influence senior stakeholders; lead complex scientific programs/change; project management/operational excellence.
Application Instructions
- Apply now via careers.amgen.com.
- No application deadline; applications accepted until sufficient candidates or selection.
- Sponsorship not guaranteed.