Principal Scientist - Clinical Pharmacology Modeling and Simulation Employer Amgen Location Thousand Oaks, California Start date Sep 22, 2026 View more categories View less categories Discipline Clinical , Clinical Research , Science/R D , Biotechnology Required Education Bachelors Degree Position Type Full time Hotbed Biotech Beach , Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Principal Scientist - Clinical Pharmacology Modeling and Simulation What you will do Lets do this. Lets change the world. In this vital role you will develop and execute integrated clinical pharmacology and model-informed drug development strategies that inform dose and regimen selection, clinical study design, regulatory filings and product labeling. You will 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. Key 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 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. Can communicate complex quantitative and clinical pharmacology concepts clearly and influence program strategy through scientifically rigorous, data-driven recommendations. Influences external scientific environment through publications, presentations, and participation in professional organizations, as appropriate. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The clinical pharmacology professional we seek is a collaborative Scientific leader with these qualifications.

Basic 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 OR Masters degree and 5 years of clinical pharmacology, pharmacometrics, modeling and simulation, or related drug-development experience OR Bachelors 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 or 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, 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. What you can expect of us 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, well 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 of 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 where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Company We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide. We live the mission. We win together. We thrive on continual challenge. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission. At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health. Connect with us to explore how you can Win, Live, and Thrive at Amgen.

Company info Website http:

//careers.amgen.com/ Phone 805-447-1000 Location Corporate Headquarters One Amgen Center Drive Thousand Oaks California 91320-1799 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Medical Science Liaison - West Working from Home Senior Clinical Research Associate Budapest, Hungary Clinical Research Associate II Beijing, Beijing