Principal Scientist - Clinical Pharmacology, Modeling & Simulation
Amgen
3 months ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Principal Scientist – Clinical Pharmacology, Modeling & Simulation
What You Will Do
- Drive modeling and simulation strategies for translational approaches to support clinical dosage selections and clinical study designs.
- Apply Quantitative Translational & Clinical Pharmacology (PK/PD modeling, M-PBPK, M-PBPK-PD, QSP), integrated with Machine Learning and Generative AI, to guide optimal clinical drug development.
- Impact therapeutic areas including oncology, rare diseases, obesity, and cardiovascular disease; across modalities from small molecules and mAbs to novel modalities.
Basic Qualifications
- Doctorate + 2 years Clinical Pharmacology & Modeling/Simulation experience; OR
- Master’s + 4 years; OR
- Bachelor’s + 6 years; OR
- Associate’s + 10 years; OR
- High school/GED + 12 years.
Preferred Qualifications
- PhD (or equivalent degrees such as MD/PharmD) in relevant fields.
- 5+ years Clinical Pharmacology/Modeling & Simulation in biotech/pharma.
- Hands-on expertise in PK/PD, M-PBPK, M-PBPK-PD, QSP to inform study design, dosage selection, DDI, special populations, ethnic sensitivity, pediatric/biopharmaceutics; expert PK/PD software knowledge.
- Track record in Model Based Drug Development (MIDD).
- Track record with global health authorities and regulatory document authoring.
- Experience leading clinical pharmacology/biopharmaceutic studies (bioequivalence, comparability, DDI, special populations, ethnic sensitivity, ADME, pediatric) and integrating results into regulatory filings/labels.
Benefits
- Total Rewards Plan (health/welfare, retirement savings, incentives/bonuses, stock-based long-term incentives, time off, and remote/hybrid where possible).
Application Instructions
- Apply via careers.amgen.com; no application deadline—applications accepted until sufficient volume or candidate selection.
What You Will Do
- Drive modeling and simulation strategies for translational approaches to support clinical dosage selections and clinical study designs.
- Apply Quantitative Translational & Clinical Pharmacology (PK/PD modeling, M-PBPK, M-PBPK-PD, QSP), integrated with Machine Learning and Generative AI, to guide optimal clinical drug development.
- Impact therapeutic areas including oncology, rare diseases, obesity, and cardiovascular disease; across modalities from small molecules and mAbs to novel modalities.
Basic Qualifications
- Doctorate + 2 years Clinical Pharmacology & Modeling/Simulation experience; OR
- Master’s + 4 years; OR
- Bachelor’s + 6 years; OR
- Associate’s + 10 years; OR
- High school/GED + 12 years.
Preferred Qualifications
- PhD (or equivalent degrees such as MD/PharmD) in relevant fields.
- 5+ years Clinical Pharmacology/Modeling & Simulation in biotech/pharma.
- Hands-on expertise in PK/PD, M-PBPK, M-PBPK-PD, QSP to inform study design, dosage selection, DDI, special populations, ethnic sensitivity, pediatric/biopharmaceutics; expert PK/PD software knowledge.
- Track record in Model Based Drug Development (MIDD).
- Track record with global health authorities and regulatory document authoring.
- Experience leading clinical pharmacology/biopharmaceutic studies (bioequivalence, comparability, DDI, special populations, ethnic sensitivity, ADME, pediatric) and integrating results into regulatory filings/labels.
Benefits
- Total Rewards Plan (health/welfare, retirement savings, incentives/bonuses, stock-based long-term incentives, time off, and remote/hybrid where possible).
Application Instructions
- Apply via careers.amgen.com; no application deadline—applications accepted until sufficient volume or candidate selection.