Scientific Associate Director - Project Toxicologist

About This Role

This role involves serving as the key scientific interface between Translational Safety & Risk Sciences (TSRS) and cross-functional project teams, guiding programs from discovery through post-marketing. The Project Toxicologist will develop and implement nonclinical safety strategies, adapting them as projects evolve, and will lead multidisciplinary TSRS teams across various therapeutic modalities and indications.

Responsibilities

• Serve as TSRS Project Team Representative (nonclinical safety representative) on core project teams and lead the TSRS sub-team
• Lead and coordinate the TSRS sub-team, leveraging the TSRS advisory network to inform human risk assessment, shape development strategy, and enable confident project decisions
• Design, implement, oversee, and interpret nonclinical safety assessment programs supporting drug development candidates with an enterprise-wide mindset
• Develop innovative study designs and nonclinical assessment strategies to address complex scientific questions, integrating AI-enabled approaches and New Approach Methodologies (NAMs) to enhance translational risk assessment and support critical development decisions
• Critically evaluate and interpret experimental data and author key sections of nonclinical strategy, governance and regulatory submissions, including first-in-human trial applications and marketing authorizations
• Communicate effectively, both orally and in writing, within TSRS and across core project teams, leadership, governance bodies, and regulatory agencies, tailoring communications to the needs and expertise of diverse audiences
• Operate effectively in a fast-paced, highly matrixed environment, balancing the needs of multiple project teams and stakeholders while ensuring proactive communication, strategic prioritization, and timely delivery of TSRS contributions
• Collaborate closely with internal Amgen scientists and external partners to advance research and development programs
• Contribute to business development activities, including licensing evaluations, due diligence assessments, and external partnerships, as appropriate
• Mentor and support fellow scientists in the design, execution, interpretation, and oversight of nonclinical studies and development programs

Requirements

• Doctorate degree (PhD, PharmD, or MD) and 4 years of Toxicology experience
• Or Master’s degree and 7 years of Toxicology experience
• Or Bachelor’s degree and 9 years of Toxicology experience
• A minimum of 8 years of drug development experience as a Project Toxicologist/Nonclinical Safety Project Team Representative at all stages of development including late-stage assets and interactions with global regulatory agencies for first-in-human trial applications and marketing authorizations
• End-to-end small- and large-molecule safety assessment experience across multiple therapeutic areas and modalities