Principal Scientist - Clinical Pharmacology Modeling and Simulation

About the role

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With a focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Responsibilities

• Serve as the clinical pharmacology lead for one or more development programs, providing scientific and strategic leadership from early clinical development through registration and post-approval development.
• Develop integrated clinical pharmacology plans addressing key program questions related to PK, PD, exposure-response, dose and regimen selection, drug-drug interactions, intrinsic and extrinsic factors, special populations, ethnic sensitivity, formulation changes/biopharmaceutics.
• Design, oversee, and plan timing for clinical pharmacology components of development programs, including first-in-human (FIH), drug-drug interaction, ADME, organ impairment, BA/BE, pediatrics, and other dedicated clinical pharmacology studies.
• Lead clinical pharmacology strategy for FIH starting dose and escalation decisions by integrating nonclinical pharmacology, toxicology, PK/PD, target engagement, translational biomarkers, and predicted human exposure.
• Contribute to analysis of preclinical PK/PD data for FIH dose selection.
• Plan, interpret, and present noncompartmental, population PK, and exposure-response analyses (and other quantitative analyses, as appropriate) to support program decisions, study design, Ph1-3 dose selection, and regulatory submissions.
• Contribute clinical pharmacology expertise to clinical development plans, protocols, study reports, IBs, regulatory briefing documents, health authority meetings, INDs, NDA/BLA/MAA, and product labeling.
• Contribute to interactions with global health authorities, including the preparation, review, and resolution of clinical pharmacology questions and regulatory information requests.
• Provide scientific oversight and review of modeling & simulation plans, evaluation of assumptions/methods, interpretation of results, and communication of conclusions to teams and governance bodies.
• Collaborate closely with pharmacometricians, statisticians, clinicians, bioanalytical scientists, toxicology/safety scientists, and regulatory colleagues to ensure timely and high-quality execution of clinical pharmacology deliverables.
• Communicate complex quantitative and clinical pharmacology concepts clearly and influence program strategy through scientifically rigorous, data-driven recommendations.
• Influence the external scientific environment through publications, presentations, and participation in professional organizations, as appropriate.

Qualifications

Basic Qualifications

• Doctorate degree (PhD, PharmD, or MD) and 2 years of clinical pharmacology, pharmacometrics, modeling and simulation, or related drug-development experience (including relevant post-doc where applicable).
• OR Master’s degree and 5 years of clinical pharmacology, pharmacometrics, modeling and simulation, or related drug-development experience.
• OR Bachelor’s degree and 7 years of clinical pharmacology, pharmacometrics, modeling and simulation, or related drug-development experience.

Preferred Qualifications

• PhD, PharmD, MD, or equivalent advanced degree in Pharmaceutical Sciences, Pharmacology, Chemical Engineering, or related quantitative discipline.
• 5+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.
• Demonstrated experience developing and executing clinical pharmacology strategies across drug development, including dose and regimen selection, study design, exposure-response (ER) assessment, and regulatory support.
• Hands-on experience in Quantitative Clinical Pharmacology approaches with a focus on population PK, PK/PD modeling, PBPK modeling, and QSP modeling to inform development decisions.
• Experience designing, overseeing, and interpreting clinical pharmacology studies, including first-in-human, DDI, food-effect, ADME, special population, BA/BE, or bridging studies.
• Established track record of contributing to regulatory submissions, health-authority interactions, responses to regulatory questions, and product labeling.
• Strong scientific judgment, leadership through influence, cross-functional collaboration, and written and verbal communication skills.
• A record of scientific accomplishment demonstrated through successful program contributions, regulatory impact, publications, presentations, or other evidence of external scientific influence.

Benefits

• 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 where possible.

Pay

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.