Safety Pharmacology Senior Scientist
Amgen
August 22, 2026
Remote friendly (Thousand Oaks, CA)
United States
Clinical Research and Development
Safety Pharmacology Senior Scientist
Responsibilities:
- Serve as Safety Pharmacology SME on cross-functional teams; develop fit-for-purpose strategies for discovery, lead optimization, candidate selection, IND-enabling, and clinical development.
- Design/oversee GLP and non-GLP safety pharmacology studies (internal or CROs) ensuring rigor, feasibility, compliance, and timely delivery.
- Evaluate/integrate nonclinical safety pharmacology data (cardiovascular, respiratory, CNS, ECG, hemodynamic, telemetry) to assess relevance, translational/ regulatory impact.
- Integrate safety pharmacology data with toxicology, pharmacology, translational biology, DMPK, clinical, and regulatory inputs for weight-of-evidence decisions.
- Support governance, regulatory strategy, milestones, and resolution of scientific/technical issues.
- Contribute safety pharmacology sections of regulatory documents (IND-enabling summaries, Investigator’s Brochures, briefing documents, regulatory question responses).
- Lead/innovate via risk-based frameworks and translational safety approaches; stay current with regulatory/scientific best practices.
- Represent externally via presentations/publications/working groups.
Qualifications:
- Basic: Doctorate + 1 yr OR Master’s + 3 yrs OR Bachelor’s + 5 yrs scientific experience.
- Preferred: PhD in related field; SME/toxicology-rep experience; broad cardiovascular/respiratory/CNS nonclinical safety; GLP/non-GLP study director/rep experience; regulatory document authoring; strong cross-functional communication; collaborate/influence in matrix.
Benefits (if eligible): retirement/savings, medical/dental/vision, life/disability, flexible spending, annual bonus/incentive, stock-based long-term incentives, time-off, flexible work models (as applicable).
Application: Apply now via careers.amgen.com; no application deadline; sponsorship not guaranteed.
Responsibilities:
- Serve as Safety Pharmacology SME on cross-functional teams; develop fit-for-purpose strategies for discovery, lead optimization, candidate selection, IND-enabling, and clinical development.
- Design/oversee GLP and non-GLP safety pharmacology studies (internal or CROs) ensuring rigor, feasibility, compliance, and timely delivery.
- Evaluate/integrate nonclinical safety pharmacology data (cardiovascular, respiratory, CNS, ECG, hemodynamic, telemetry) to assess relevance, translational/ regulatory impact.
- Integrate safety pharmacology data with toxicology, pharmacology, translational biology, DMPK, clinical, and regulatory inputs for weight-of-evidence decisions.
- Support governance, regulatory strategy, milestones, and resolution of scientific/technical issues.
- Contribute safety pharmacology sections of regulatory documents (IND-enabling summaries, Investigator’s Brochures, briefing documents, regulatory question responses).
- Lead/innovate via risk-based frameworks and translational safety approaches; stay current with regulatory/scientific best practices.
- Represent externally via presentations/publications/working groups.
Qualifications:
- Basic: Doctorate + 1 yr OR Master’s + 3 yrs OR Bachelor’s + 5 yrs scientific experience.
- Preferred: PhD in related field; SME/toxicology-rep experience; broad cardiovascular/respiratory/CNS nonclinical safety; GLP/non-GLP study director/rep experience; regulatory document authoring; strong cross-functional communication; collaborate/influence in matrix.
Benefits (if eligible): retirement/savings, medical/dental/vision, life/disability, flexible spending, annual bonus/incentive, stock-based long-term incentives, time-off, flexible work models (as applicable).
Application: Apply now via careers.amgen.com; no application deadline; sponsorship not guaranteed.