BioSpace
Principal Scientist - Clinical Pharmacology, Modeling & Simulation
BioSpace, South San Francisco, California, us, 94083
Principal Scientist - Clinical Pharmacology, Modeling & Simulation
2 days ago Be among the first 25 applicants
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 biotech in our fight against the world’s toughest diseases. With focus on oncology, inflammation, general medicine, and rare disease, we reach millions of patients each year. As part of the Amgen team, you’ll help make a lasting impact by researching, manufacturing, and delivering innovative medicines.
What You Will Do Lead and advance innovative modeling and simulation strategies for translational approaches that support clinical dosage selection and study design. Your work will span therapeutic areas such as oncology, rare disease, obesity, cardiovascular disease, and diverse modalities from small molecules to novel therapies.
Apply quantitative translational and clinical pharmacology approaches—including PK/PD modeling, mechanistic PBPK/PD modeling, QSP modeling, and emerging machine‑learning and generative AI techniques—to guide optimal drug development.
Basic Qualifications
Doctorate degree and 2 years of clinical pharmacology and modeling & simulation experience
or Master’s degree and 4 years of experience
or Bachelor’s degree and 6 years of experience
or Associate’s degree and 10 years of experience
or High school diploma/GED and 12 years of experience
Preferred Qualifications
PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemical Engineering, or equivalent professional degree (e.g., MD, PharmD)
5+ years of experience in clinical pharmacology, modeling & simulation within biotech/pharma
Hands‑on experience with PK/PD, M‑PBPK, M‑PBPK‑PD, and QSP modeling to inform study design, dosing, drug‑drug interactions, special populations, ethnic sensitivity, pediatric studies, and biopharmaceuticals
Expert knowledge of relevant software for PK/PD and modeling
Established track record of model‑based drug development (MIDD)
Experience with global health authorities, regulatory submissions, and regulatory guidance
Leadership in designing and implementing clinical pharmacology and biopharmaceutic studies and integrating results into regulatory filings and product labeling
Benefits Amgen offers a comprehensive rewards plan that includes health and welfare plans, retirement and savings options, financial plans, and competitive bonuses and stock‑based incentives. Working arrangements may include remote and hybrid options. Award‑winning time‑off plans support work/life balance.
Retirement and savings plan with company contributions
Group medical, dental, and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock‑based long‑term incentives
Award‑winning time‑off plans
Flexible work models (remote/hybrid) where possible
Application Amgen does not have a set application deadline and will continue accepting applications until we fill the position.
Equal Opportunity Employment 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 provide reasonable accommodations to applicants with disabilities.
#J-18808-Ljbffr
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 biotech in our fight against the world’s toughest diseases. With focus on oncology, inflammation, general medicine, and rare disease, we reach millions of patients each year. As part of the Amgen team, you’ll help make a lasting impact by researching, manufacturing, and delivering innovative medicines.
What You Will Do Lead and advance innovative modeling and simulation strategies for translational approaches that support clinical dosage selection and study design. Your work will span therapeutic areas such as oncology, rare disease, obesity, cardiovascular disease, and diverse modalities from small molecules to novel therapies.
Apply quantitative translational and clinical pharmacology approaches—including PK/PD modeling, mechanistic PBPK/PD modeling, QSP modeling, and emerging machine‑learning and generative AI techniques—to guide optimal drug development.
Basic Qualifications
Doctorate degree and 2 years of clinical pharmacology and modeling & simulation experience
or Master’s degree and 4 years of experience
or Bachelor’s degree and 6 years of experience
or Associate’s degree and 10 years of experience
or High school diploma/GED and 12 years of experience
Preferred Qualifications
PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemical Engineering, or equivalent professional degree (e.g., MD, PharmD)
5+ years of experience in clinical pharmacology, modeling & simulation within biotech/pharma
Hands‑on experience with PK/PD, M‑PBPK, M‑PBPK‑PD, and QSP modeling to inform study design, dosing, drug‑drug interactions, special populations, ethnic sensitivity, pediatric studies, and biopharmaceuticals
Expert knowledge of relevant software for PK/PD and modeling
Established track record of model‑based drug development (MIDD)
Experience with global health authorities, regulatory submissions, and regulatory guidance
Leadership in designing and implementing clinical pharmacology and biopharmaceutic studies and integrating results into regulatory filings and product labeling
Benefits Amgen offers a comprehensive rewards plan that includes health and welfare plans, retirement and savings options, financial plans, and competitive bonuses and stock‑based incentives. Working arrangements may include remote and hybrid options. Award‑winning time‑off plans support work/life balance.
Retirement and savings plan with company contributions
Group medical, dental, and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock‑based long‑term incentives
Award‑winning time‑off plans
Flexible work models (remote/hybrid) where possible
Application Amgen does not have a set application deadline and will continue accepting applications until we fill the position.
Equal Opportunity Employment 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 provide reasonable accommodations to applicants with disabilities.
#J-18808-Ljbffr