Scientific Associate Director - Project Toxicologist

About the role

Amgen is looking for a Scientific Associate Director, Project Toxicologist, to act as the key scientific interface between Translational Safety & Risk Sciences (TSRS) and cross-functional project teams from discovery through post-marketing. The role reports to a Senior Director Project Team Representative (PTR) Manager and leads a TSRS sub-team, partnering with teams developing therapeutics in inflammation, rare diseases, oncology and cardiometabolic diseases.

Key responsibilities

• Serve as TSRS PTR (nonclinical safety representative) on core project teams and lead the TSRS sub-team
• Develop and implement nonclinical safety strategies aligned with regulatory expectations, adapting them as programs evolve
• Design, implement, oversee and interpret nonclinical safety assessment programs for drug development candidates
• Integrate AI-enabled approaches and New Approach Methodologies (NAMs) into study designs and assessment strategies
• Evaluate experimental data and author key sections of nonclinical strategy, governance and regulatory submissions, including first-in human trial applications and marketing authorizations
• Communicate with TSRS, project teams, leadership, governance bodies and regulatory agencies
• Contribute to business development, including licensing evaluations and due diligence
• Mentor colleagues on nonclinical studies and development programs

Required profile

• Basic: PhD, PharmD or MD with 4 years of toxicology experience, or Master's with 7 years, or Bachelor's with 9 years of toxicology experience
• Preferred: 8+ years as a Project Toxicologist/PTR, end-to-end small- and large-molecule safety assessment experience, and experience with siRNA, ADCs, antibody-peptide conjugates or targeted protein degraders
• Preferred: board certification by the American Board of Toxicology, matrixed management experience, and external visibility as a toxicology expert

What we offer

• Annual salary range posted, plus a discretionary bonus or sales-based incentive plan
• Retirement and savings plan, medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• Stock-based long-term incentives and flexible work models, including remote and hybrid options