Safety Pharmacology Senior Scientist

Safety Pharmacology Senior Scientist

In this vital role you will join the Safety Pharmacology Sciences team as a subject matter expert in nonclinical safety pharmacology. You will partner closely with project teams to develop and execute integrated safety pharmacology strategies that support discovery, candidate selection, IND‑enabling packages, and regulatory submissions. The role requires strong scientific judgment, regulatory awareness, cross‑functional collaboration, and the ability to translate complex nonclinical safety pharmacology data into clear, actionable recommendations for project teams and governance forums.

• 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.
• 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.
• Integrate safety pharmacology data with toxicology, pharmacology, translational biology, DMPK, clinical, and regulatory information to support weight‑of‑evidence decision‑making.
• 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.

• Contribute to the 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.

• Represent Amgen externally through scientific presentations, publications, professional societies, consortia, or cross‑industry working groups, as appropriate.
• Build external scientific relationships that enhance Amgen’s visibility and influence in safety pharmacology.
• Monitor and contribute to emerging best practices in cardiovascular, respiratory, CNS, and integrated nonclinical safety assessment.

• Doctorate degree and 1 year of scientific experience, or
• Masters degree and 3 years of scientific experience, or
• Bachelors degree and 5 years of scientific experience.

• PhD in Pharmacology, Neuroscience, Physiology, Biomedical Sciences, or related field.
• Experience supporting discovery and development project teams as a safety pharmacology SME or toxicology representative.
• Broad experience in nonclinical safety pharmacology across cardiovascular, respiratory and CNS domains.
• Experience serving as a study director, project representative, or subject matter expert for GLP and/or non‑GLP safety pharmacology studies.
• Experience authoring or contributing to regulatory documents such as Investigators Brochures, IND sections, briefing documents, or responses to regulatory questions.
• Strong cross‑functional communication and problem‑solving skills.
• Demonstrated ability to collaborate across disciplines, influence without direct authority, and manage multiple…