Scientific Associate Director - Safety Pharmacology
Amgen
14 hours ago
On-site
Thousand Oaks, CA
Clinical Research and Development
Scientific Associate Director – Safety Pharmacology
What You Will Do
- Lead safety pharmacology lab-based activities within Safety Pharmacology Sciences and support Translational Safety & Risk Sciences (TSRS) nonclinical safety evaluation.
- Manage in vitro cardiac safety and electrophysiology laboratory and staff.
- Lead and coordinate safety issue resolution studies (in vitro and in vivo).
- Serve as Safety Pharmacology SME on project teams and contribute to external scientific initiatives.
- Integrate data across assay systems/modalities to support candidate selection, risk assessment, clinical translation, regulatory strategy, and industry best practices.
Key Responsibilities
- Oversee ion channel, hiPSC-derived cardiomyocyte, and isolated heart assays.
- Manage exploratory and GLP-compliant studies (outsourcing, protocol development, data review, report finalization).
- Supervise staff; ensure high-quality timely data generation, study tracking, QC, reporting, and stakeholder communication.
- Maintain compliance with data integrity, safety, and environmental standards.
- Establish qualified NAMs models with internal/external partners.
- Provide safety risk evaluation for target/off-target risks across diverse modalities per ICH guidelines.
- Guide study design, data interpretation, next-step recommendations; support regulatory filings/inquiries.
- Coordinate investigative studies (e.g., human primary tissue acquisition; functional studies) with internal/external (CRO) labs.
- Collaborate to integrate in vitro and in silico approaches.
- Build collaborations; publish/present; promote adoption of human-relevant in vitro models; contribute to modality-specific safety thinking.
Basic Qualifications
- Doctorate + 4 years relevant scientific experience; or Master’s + 7 years; or Bachelor’s + 9 years.
Preferred Qualifications
- PhD in Pharmacology/Neuroscience/Physiology/Biomedical Sciences or related.
- In vitro/in vivo safety pharmacology experience (cardiovascular, respiratory, CNS).
- Knowledge of cardiac ion channel assays (e.g., hERG, Nav1.5, Cav1.2) and hiPSC-derived cardiomyocyte/isolated heart assays.
- Experience managing outsourced studies/CROs; serving as SME/toxicology representative.
- GLP-enabling safety pharmacology package familiarity; integration with toxicology.
- People leadership/lab management; strong cross-functional communication and problem-solving; publications and external forums.
Benefits
- Total Rewards Plan (eligibility-based): health and welfare plans, financial plans/retirement savings opportunities, work/life balance, career development, employee benefits package (medical/dental/vision, life/disability, flexible spending), discretionary annual bonus, stock-based long-term incentives, time-off plans, flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com; no application deadline—applications accepted until sufficient candidates are received or selected.
What You Will Do
- Lead safety pharmacology lab-based activities within Safety Pharmacology Sciences and support Translational Safety & Risk Sciences (TSRS) nonclinical safety evaluation.
- Manage in vitro cardiac safety and electrophysiology laboratory and staff.
- Lead and coordinate safety issue resolution studies (in vitro and in vivo).
- Serve as Safety Pharmacology SME on project teams and contribute to external scientific initiatives.
- Integrate data across assay systems/modalities to support candidate selection, risk assessment, clinical translation, regulatory strategy, and industry best practices.
Key Responsibilities
- Oversee ion channel, hiPSC-derived cardiomyocyte, and isolated heart assays.
- Manage exploratory and GLP-compliant studies (outsourcing, protocol development, data review, report finalization).
- Supervise staff; ensure high-quality timely data generation, study tracking, QC, reporting, and stakeholder communication.
- Maintain compliance with data integrity, safety, and environmental standards.
- Establish qualified NAMs models with internal/external partners.
- Provide safety risk evaluation for target/off-target risks across diverse modalities per ICH guidelines.
- Guide study design, data interpretation, next-step recommendations; support regulatory filings/inquiries.
- Coordinate investigative studies (e.g., human primary tissue acquisition; functional studies) with internal/external (CRO) labs.
- Collaborate to integrate in vitro and in silico approaches.
- Build collaborations; publish/present; promote adoption of human-relevant in vitro models; contribute to modality-specific safety thinking.
Basic Qualifications
- Doctorate + 4 years relevant scientific experience; or Master’s + 7 years; or Bachelor’s + 9 years.
Preferred Qualifications
- PhD in Pharmacology/Neuroscience/Physiology/Biomedical Sciences or related.
- In vitro/in vivo safety pharmacology experience (cardiovascular, respiratory, CNS).
- Knowledge of cardiac ion channel assays (e.g., hERG, Nav1.5, Cav1.2) and hiPSC-derived cardiomyocyte/isolated heart assays.
- Experience managing outsourced studies/CROs; serving as SME/toxicology representative.
- GLP-enabling safety pharmacology package familiarity; integration with toxicology.
- People leadership/lab management; strong cross-functional communication and problem-solving; publications and external forums.
Benefits
- Total Rewards Plan (eligibility-based): health and welfare plans, financial plans/retirement savings opportunities, work/life balance, career development, employee benefits package (medical/dental/vision, life/disability, flexible spending), discretionary annual bonus, stock-based long-term incentives, time-off plans, flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com; no application deadline—applications accepted until sufficient candidates are received or selected.