Scientific Associate Director - Project Toxicologist (Biotech)

Location: United States; Corporate Headquarters: Thousand Oaks, California. Conditions: Washington, D.C.

Company

Amgen is a biotechnology company developing and delivering medicines for serious illnesses across oncology, inflammation, general medicine, rare disease, and cardiometabolic disease.

What you will do

• Serve as the Translational Safety & Risk Sciences representative on cross-functional project teams from discovery through post-marketing.
• Lead TSRS sub-teams and coordinate advisory networks 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 using AI-enabled approaches and New Approach Methodologies to address complex scientific questions.
• Author nonclinical strategy, governance, and regulatory submission sections, including first-in-human trial applications and marketing authorizations.
• Collaborate with internal scientists and external partners, support due diligence activities, and mentor fellow scientists.

Requirements

• PhD, PharmD, or MD with at least 4 years of toxicology experience; or a master’s degree with 7 years; or a bachelor’s degree with 9 years.
• At least 8 years of drug development experience as a Project Toxicologist or Nonclinical Safety Project Team Representative is preferred.
• Experience with end-to-end small- and large-molecule safety assessment across multiple therapeutic areas and modalities.
• Experience with regulatory agencies, first-in-human trial applications, marketing authorizations, and cross-functional scientific leadership.
• Strong written and verbal communication, matrixed management experience, and the ability to influence multidisciplinary partners.
• Board certification by the American Board of Toxicology is preferred.

Nice to have

• Nonclinical safety experience with siRNA therapeutics, antibody-drug conjugates, antibody-peptide conjugates, or targeted protein degraders.
• Subject matter expertise in a toxicology discipline such as drug-induced liver injury.
• Experience supporting business development due diligence evaluations.
• External presentations, publications, or leadership in collaborative scientific groups.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions, stock-based long-term incentives, and an annual bonus program.
• Award-winning time-off plans and career development opportunities.
• Flexible work models, including remote and hybrid arrangements where possible.

Hiring process

• Applications are accepted until the position is filled; no fixed application deadline is specified.
• Sponsorship for this role is not guaranteed.