Scientific Associate Director - Project Toxicologist

• Serve as TSRS PTR (nonclinical safety representative) on core project teams and lead the TSRS sub-team.  The TSRS PTR is a key ambassador for the TSRS mission: Driving translational safety strategy and innovation to inform human risk with precision, insight, and impact, accelerating transformative therapies to patients.
• Lead and coordinate the TSRS sub-team, fully 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.

• 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
• Preferred experience in nonclinical safety assessment of siRNA therapeutics, antibody-drug conjugates (ADCs), antibody-peptide conjugates, and/or targeted protein degraders
• Demonstrate a proven ability to serve as a highly effective cross-functional thought partner, driving alignment and advancing complex scientific discussions across R&D functions
• Subject matter expertise in a defined area of toxicology (e.g. drug-induced liver injury)
• Experience supporting business development efforts through due diligence evaluations as a translational safety team member
• Scientific leader with matrixed management experience
• Board certification by the American Board of Toxicology
• Excellent communicator with a proven ability to influence a broad spectrum of partners toward achieving business goals
• External visibility as a toxicology subject matter expert, demonstrated by external presentations and publications and/or leadership or active participation in external collaborative groups

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible