Safety Pharmacology Senior Scientist

Safety Pharmacology Strategy and Project Team Support

Serve as a Safety Pharmacology subject matter expert on cross-functional project teams, developing fit-for-purpose strategies and providing strategic guidance across discovery, lead optimization, candidate selection, IND-enabling, and clinical development stages, aligned with program biology, modality, target risk, regulatory expectations, and development needs.

Design and oversee GLP and non-GLP safety pharmacology studies conducted internally or at external contract research organizations, ensuring scientific rigor, operational feasibility, compliance, and timely delivery.

Evaluate and integrate nonclinical safety pharmacology data, including cardiovascular, respiratory, CNS, ECG, hemodynamic, telemetry, and related endpoints, to assess biological relevance, translational significance, and regulatory impact.

Contribute to internal governance presentations, project team discussions, regulatory strategy meetings, development milestone decisions, and resolution of study-related scientific or technical issues.

Contribute to safety pharmacology sections of regulatory documents, including IND-enabling summaries, Investigators Brochures, briefing documents, responses to regulatory questions, and internal development reports.

Scientific Leadership and Innovation

Contribute to development and implementation of innovative safety pharmacology approaches, including fit-for-purpose study designs, risk-based assessment frameworks, and translational safety strategies.

Stay current with evolving regulatory expectations, industry best practices, scientific literature, and emerging methodologies in safety pharmacology.

Participate in internal initiatives to improve safety pharmacology processes, templates, data standards, reporting practices, and decision frameworks.

Promote high scientific standards, quality, and compliance across internal and external study activities.

Contribute to a culture of scientific curiosity, collaboration, accountability, and continuous improvement.

External Engagement

Represent Amgen externally through scientific presentations, publications, professional societies, consortia, or cross-industry working groups, as appropriate.

Build external scientific relationships that enhance Amgens visibility and influence in safety pharmacology.

Monitor and contribute to emerging best practices in cardiovascular, respiratory, CNS, and integrated nonclinical safety assessment.