BioSpace
Principal Scientist - Clinical Pharmacology, Modeling & Simulation
BioSpace, South San Francisco, California, us, 94083
Overview
Principal Scientist - Clinical Pharmacology, Modeling & Simulation role at Amgen. This position drives innovative modeling and simulation strategies for translational approaches to support clinical dosage selections and clinical study designs across therapeutic areas including oncology, rare diseases, obesity, and cardiovascular disease, spanning modalities from small molecules and mAbs to novel modalities. What You Will Do
The Clinical Pharmacology, Modeling & Simulation Department at Amgen seeks a Principal Scientist who will: Apply quantitative translational and clinical pharmacology approaches such as PK/PD modeling, mechanistic PBPK, M-PBPK-PD modeling, Quantitative Systems Pharmacology (QSP), and integrate emerging machine learning and generative AI approaches to guide clinical drug development. Drive innovative modeling and simulation strategies to support translational science and clinical study designs and dosage selections. Contribute to work across therapeutic areas including oncology, rare diseases, obesity, and cardiovascular disease, and across modalities from small molecules to novel modalities. What We Expect Of You
We are seeking a leader who brings unique contributions to serve patients. The ideal candidate will have the following qualifications and experience. Basic Qualifications
Doctorate degree and 2 years of Clinical Pharmacology and Modeling & Simulation experience Or Masters degree and 4 years of Clinical Pharmacology and Modeling & Simulation experience Or Bachelors degree and 6 years of Clinical Pharmacology and Modeling & Simulation experience Or Associates degree and 10 years of Clinical Pharmacology and Modeling & Simulation experience Or High school diploma / GED and 12 years of Clinical Pharmacology and Modeling & Simulation experience Preferred Qualifications
PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or Chemical Engineering or equivalent professional degrees e.g. MD, PharmD) 5+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry Hands-on experience in PK/PD, M-PBPK, M-PBPK-PD, and QSP modeling to inform clinical study designs, dosage selection, DDI, special populations, ethnic sensitivity, pediatric and biopharmaceutics studies; expert knowledge of software for PK/PD, M-PBPK, M-PBPK-PD, & QSP modeling Established track-record of Model Based Drug Development (MIDD) Regulatory interaction experience, including authoring regulatory documents and knowledge of global regulatory requirements and guidance Experience leading the design and implementation of clinical pharmacology and biopharmaceutic studies (bioequivalence, bio-comparability, DDI, special populations, ethnic sensitivity, ADME, pediatric) and integrating results into regulatory filings and product labels What You Can Expect From Us
Amgen supports professional and personal growth with competitive benefits and a collaborative culture. The total rewards plan may include health and welfare plans, retirement savings, work/life balance, and career development opportunities. Salary range is location-dependent and may vary based on skills, experience, and qualifications. In addition to base salary, Amgen offers a Total Rewards Plan including benefits, bonuses, stock-based incentives, and flexible work arrangements where possible. A comprehensive benefits package with group medical, dental, vision, life and disability insurance, and retirement plans Discretionary annual bonus program (or field sales incentive where applicable) Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible Apply now and make a lasting impact with the Amgen team. For more information, please visit careers.amgen.com. In accordance with law, Amgen provides reasonable accommodations for applicants with disabilities during the application process. Equal Opportunity
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. Reasonable accommodations are available to applicants with disabilities. Please contact us to request accommodation.
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Principal Scientist - Clinical Pharmacology, Modeling & Simulation role at Amgen. This position drives innovative modeling and simulation strategies for translational approaches to support clinical dosage selections and clinical study designs across therapeutic areas including oncology, rare diseases, obesity, and cardiovascular disease, spanning modalities from small molecules and mAbs to novel modalities. What You Will Do
The Clinical Pharmacology, Modeling & Simulation Department at Amgen seeks a Principal Scientist who will: Apply quantitative translational and clinical pharmacology approaches such as PK/PD modeling, mechanistic PBPK, M-PBPK-PD modeling, Quantitative Systems Pharmacology (QSP), and integrate emerging machine learning and generative AI approaches to guide clinical drug development. Drive innovative modeling and simulation strategies to support translational science and clinical study designs and dosage selections. Contribute to work across therapeutic areas including oncology, rare diseases, obesity, and cardiovascular disease, and across modalities from small molecules to novel modalities. What We Expect Of You
We are seeking a leader who brings unique contributions to serve patients. The ideal candidate will have the following qualifications and experience. Basic Qualifications
Doctorate degree and 2 years of Clinical Pharmacology and Modeling & Simulation experience Or Masters degree and 4 years of Clinical Pharmacology and Modeling & Simulation experience Or Bachelors degree and 6 years of Clinical Pharmacology and Modeling & Simulation experience Or Associates degree and 10 years of Clinical Pharmacology and Modeling & Simulation experience Or High school diploma / GED and 12 years of Clinical Pharmacology and Modeling & Simulation experience Preferred Qualifications
PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or Chemical Engineering or equivalent professional degrees e.g. MD, PharmD) 5+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry Hands-on experience in PK/PD, M-PBPK, M-PBPK-PD, and QSP modeling to inform clinical study designs, dosage selection, DDI, special populations, ethnic sensitivity, pediatric and biopharmaceutics studies; expert knowledge of software for PK/PD, M-PBPK, M-PBPK-PD, & QSP modeling Established track-record of Model Based Drug Development (MIDD) Regulatory interaction experience, including authoring regulatory documents and knowledge of global regulatory requirements and guidance Experience leading the design and implementation of clinical pharmacology and biopharmaceutic studies (bioequivalence, bio-comparability, DDI, special populations, ethnic sensitivity, ADME, pediatric) and integrating results into regulatory filings and product labels What You Can Expect From Us
Amgen supports professional and personal growth with competitive benefits and a collaborative culture. The total rewards plan may include health and welfare plans, retirement savings, work/life balance, and career development opportunities. Salary range is location-dependent and may vary based on skills, experience, and qualifications. In addition to base salary, Amgen offers a Total Rewards Plan including benefits, bonuses, stock-based incentives, and flexible work arrangements where possible. A comprehensive benefits package with group medical, dental, vision, life and disability insurance, and retirement plans Discretionary annual bonus program (or field sales incentive where applicable) Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible Apply now and make a lasting impact with the Amgen team. For more information, please visit careers.amgen.com. In accordance with law, Amgen provides reasonable accommodations for applicants with disabilities during the application process. Equal Opportunity
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. Reasonable accommodations are available to applicants with disabilities. Please contact us to request accommodation.
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