Scientific Associate Director, Clinical Pharmacology

Role Summary

Scientific Associate Director, Clinical Pharmacology is a leadership role within the Clinical Pharmacology, Modeling & Simulation Department at Amgen, responsible for developing and implementing Clinical Pharmacology and Pharmacometric strategies for innovative therapeutic modalities including Bi-specific T-cell engagers, Bi-specific antibodies, oncolytic viruses, antibody-drug-conjugates as well as traditional small molecules, monoclonal antibodies and therapeutic peptides. Based in South San Francisco, CA, the role guides drug development using PK/PD modeling and Model-Based Drug Development to ensure safe and effective dosing across patient subpopulations and to optimize new drug development.

Responsibilities

• Lead development and implementation of Clinical Pharmacology and Pharmacometric strategies for cutting-edge modalities, ensuring optimal dosing regimens across diverse patient populations.
• Apply innovative Quantitative PK/PD approaches (including Population PK/PD, PBPK, mechanistic PK/PD, and QSP) to guide global drug development and represent the Clinical Pharmacology, Modeling & Simulation Department in cross-functional teams.

Qualifications

• Required: Doctorate degree (PhD OR PharmD OR MD) in Pharmacokinetics, Pharmaceutical Sciences, or Pharmacology with 4 years of Clinical Pharmacology, Modeling & Simulation experience in the Biotechnology/Pharmaceutical Industry; or Master’s degree with 7 years of relevant experience; or Bachelor’s degree with 9 years of relevant experience.
• Preferred: PhD or equivalent (e.g., MD, PharmD) in Pharmacokinetics, Pharmaceutical Sciences, or Pharmacology; 4+ years of Clinical Pharmacology, Modeling & Simulation experience; hands-on PK/PD modeling experience (Population PK/PD, PBPK) to inform design for DDI, special populations, ethnic sensitivity, pediatric, and biopharmaceutics studies; expert PBPK software knowledge; experience leading clinical pharmacology and biopharmaceutics studies and integrating results into regulatory filings and product labels; established track record in Model-Based Drug Development and regulatory interactions.