BioSpace
Principal Scientist - Clinical Pharmacology, Modeling & Simulation
BioSpace, South San Francisco, California, us, 94083
Principal Scientist - Clinical Pharmacology, Modeling & Simulation
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Overview Amgen’s mission is to serve patients living with serious illnesses. The Clinical Pharmacology, Modeling & Simulation Department seeks a Principal Scientist to drive innovative modeling and simulation strategies that support clinical dosage selections and study designs across therapeutic areas such as oncology, rare disease, obesity, and cardiovascular disease.
What You Will Do The Principal Scientist will be a subject‑matter expert who applies quantitative translational and clinical pharmacology approaches—including PK/PD modeling, mechanistic physiologically‑based PK/PD modeling, quantitative systems pharmacology modeling, and emerging machine learning and generative AI—to guide optimal clinical drug development.
What We Expect Of You 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, Pharmaceutical Sciences, Pharmacology, or Chemical Engineering or equivalent professional degrees such as MD, PharmD).
5+ years of experience in Clinical Pharmacology, Modeling & Simulation in the biotechnology/pharmaceutical industry.
Hands‑on experience in PK/PD modeling, M‑PBPK modeling, M‑PBPK‑PD modeling, and QSP modeling to inform clinical study designs and optimal dosage selection.
Expert knowledge of commonly used software for PK/PD, M‑PBPK, M‑PBPK‑PD, and QSP modeling.
Established track record of Model‑Based Drug Development (MIDD).
Experience with global health authorities, regulatory document authoring, and global regulatory requirements.
Experience designing and implementing clinical pharmacology and biopharmaceutic studies, integrating results into regulatory filings and product labels.
Benefits
Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, dental, vision, life and disability insurance, and flexible spending accounts.
Discretionary annual bonus program and long‑term incentive plans.
Award‑winning time‑off plans and flexible work models (remote and hybrid where possible).
Equal Opportunity Employer 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.
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Overview Amgen’s mission is to serve patients living with serious illnesses. The Clinical Pharmacology, Modeling & Simulation Department seeks a Principal Scientist to drive innovative modeling and simulation strategies that support clinical dosage selections and study designs across therapeutic areas such as oncology, rare disease, obesity, and cardiovascular disease.
What You Will Do The Principal Scientist will be a subject‑matter expert who applies quantitative translational and clinical pharmacology approaches—including PK/PD modeling, mechanistic physiologically‑based PK/PD modeling, quantitative systems pharmacology modeling, and emerging machine learning and generative AI—to guide optimal clinical drug development.
What We Expect Of You 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, Pharmaceutical Sciences, Pharmacology, or Chemical Engineering or equivalent professional degrees such as MD, PharmD).
5+ years of experience in Clinical Pharmacology, Modeling & Simulation in the biotechnology/pharmaceutical industry.
Hands‑on experience in PK/PD modeling, M‑PBPK modeling, M‑PBPK‑PD modeling, and QSP modeling to inform clinical study designs and optimal dosage selection.
Expert knowledge of commonly used software for PK/PD, M‑PBPK, M‑PBPK‑PD, and QSP modeling.
Established track record of Model‑Based Drug Development (MIDD).
Experience with global health authorities, regulatory document authoring, and global regulatory requirements.
Experience designing and implementing clinical pharmacology and biopharmaceutic studies, integrating results into regulatory filings and product labels.
Benefits
Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, dental, vision, life and disability insurance, and flexible spending accounts.
Discretionary annual bonus program and long‑term incentive plans.
Award‑winning time‑off plans and flexible work models (remote and hybrid where possible).
Equal Opportunity Employer 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.
#J-18808-Ljbffr