Scientific Associate Director - Project Toxicologist
Amgen
August 21, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Scientific Associate Director - Project Toxicologist
What You Will Do
Serve as key scientific interface between Translational Safety & Risk Sciences (TSRS) and cross-functional project teams from discovery through post-marketing; develop and implement fit-for-purpose nonclinical safety strategies aligned with regulatory expectations; adapt strategies based on emerging data while leading multidisciplinary TSRS teams.
Key Responsibilities
- Serve as TSRS PTR (nonclinical safety representative) on core project teams and lead the TSRS sub-team.
- Lead and coordinate the TSRS sub-team; leverage TSRS advisory network to inform human risk assessment and development strategy.
- Design, implement, oversee, and interpret nonclinical safety assessment programs for drug development candidates.
- Develop innovative study designs and nonclinical assessment strategies; integrate AI-enabled approaches and New Approach Methodologies (NAMs).
- Critically evaluate experimental data; author key sections of nonclinical strategy, governance, and regulatory submissions (e.g., first-in-human and marketing authorizations).
- Communicate effectively with TSRS, project teams, leadership/governance bodies, and regulatory agencies.
- Collaborate with internal scientists and external partners; support business development via licensing evaluations and due diligence as appropriate.
- Mentor and support scientists on nonclinical studies and development programs.
Basic Qualifications
- Doctorate (PhD, PharmD, or MD) and 4 years Toxicology experience; OR Master’s and 7 years; OR Bachelor’s and 9 years.
Preferred Qualifications
- 8+ years as Project Toxicologist/Nonclinical Safety Project Team Representative across development stages and global regulatory interactions.
- End-to-end small- and large-molecule safety assessment across modalities; experience with siRNA, ADCs, antibody-peptide conjugates, and/or targeted protein degraders.
- Subject matter expertise in a toxicology area (e.g., DILI); due diligence support; matrixed leadership/management; Board certification (American Board of Toxicology); external visibility.
Total Rewards/Benefits
- Retirement and Savings Plan (company contributions), medical/dental/vision, life/disability insurance, flexible spending accounts, discretionary annual bonus (or sales incentive), stock-based long-term incentives, time-off, and remote/hybrid work where possible.
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications are accepted until a sufficient number are received or a candidate is selected.
What You Will Do
Serve as key scientific interface between Translational Safety & Risk Sciences (TSRS) and cross-functional project teams from discovery through post-marketing; develop and implement fit-for-purpose nonclinical safety strategies aligned with regulatory expectations; adapt strategies based on emerging data while leading multidisciplinary TSRS teams.
Key Responsibilities
- Serve as TSRS PTR (nonclinical safety representative) on core project teams and lead the TSRS sub-team.
- Lead and coordinate the TSRS sub-team; leverage TSRS advisory network to inform human risk assessment and development strategy.
- Design, implement, oversee, and interpret nonclinical safety assessment programs for drug development candidates.
- Develop innovative study designs and nonclinical assessment strategies; integrate AI-enabled approaches and New Approach Methodologies (NAMs).
- Critically evaluate experimental data; author key sections of nonclinical strategy, governance, and regulatory submissions (e.g., first-in-human and marketing authorizations).
- Communicate effectively with TSRS, project teams, leadership/governance bodies, and regulatory agencies.
- Collaborate with internal scientists and external partners; support business development via licensing evaluations and due diligence as appropriate.
- Mentor and support scientists on nonclinical studies and development programs.
Basic Qualifications
- Doctorate (PhD, PharmD, or MD) and 4 years Toxicology experience; OR Master’s and 7 years; OR Bachelor’s and 9 years.
Preferred Qualifications
- 8+ years as Project Toxicologist/Nonclinical Safety Project Team Representative across development stages and global regulatory interactions.
- End-to-end small- and large-molecule safety assessment across modalities; experience with siRNA, ADCs, antibody-peptide conjugates, and/or targeted protein degraders.
- Subject matter expertise in a toxicology area (e.g., DILI); due diligence support; matrixed leadership/management; Board certification (American Board of Toxicology); external visibility.
Total Rewards/Benefits
- Retirement and Savings Plan (company contributions), medical/dental/vision, life/disability insurance, flexible spending accounts, discretionary annual bonus (or sales incentive), stock-based long-term incentives, time-off, and remote/hybrid work where possible.
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications are accepted until a sufficient number are received or a candidate is selected.