Principal Scientist - Clinical Pharmacology Modeling and Simulation

About the role

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. 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 our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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.
• Work closely with colleagues across clinical development, pharmacometrics, biostatistics, nonclinical development, bioanalytical sciences, regulatory affairs, and other functions to translate emerging data into clear and actionable drug-development decisions.
• 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 on 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 external scientific environment through publications, presentations, and participation in professional organizations, as appropriate.

Qualifications

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