Amgen · 4 days ago
Scientific Associate Director, Clinical Pharmacology
Amgen is a biotechnology company dedicated to serving patients living with serious illnesses. The Scientific Associate Director, Clinical Pharmacology will be responsible for developing and implementing Clinical Pharmacology and Pharmacometric strategies, applying innovative approaches to guide optimal drug development in various therapeutic modalities.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Responsible for the development and implementation of the Clinical Pharmacology and Pharmacometric strategies for cutting-edge innovative therapeutic modalities including Bi-specific T-cell engagers, Bi-specific antibodies, oncolytic viruses, antibody-drug-conjugates as well as traditional small molecules, mono-clonal antibodies and therapeutic peptides
Apply innovative Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches and clinical pharmacology strategies and principles to guide optimal drug development
Represent the Clinical Pharmacology, Modeling & Simulation Department at the global drug development teams
Ensure development of safe & effective dosing regimens for various patient sub-populations & also to ensure optimal new drug development
Qualification
Required
Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology and 4 years of Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry
Or
Master's degree in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology and 7 years of Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry
Or
Bachelor's degree in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology and 9 years of Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry
Preferred
PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or equivalent professional degrees e.g. MD, PharmD)
4+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry
Hands-on experience in Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches with a focus on Population PK/PD modeling, Physiologically Based Pharmacokinetic (PBPK) modeling to inform clinical study designs for drug-drug interaction, special population, ethnic sensitivity, pediatric and biopharmaceutics studies. Expert knowledge of commonly used software for PBPK modeling required
Experience in leading the design and implementation of clinical pharmacology and biopharmaceutic studies including bioequivalence, bio-comparability, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies and integrating results into regulatory filings, and product labels
Established track-record of Model Based Drug Development
Established track-record of interaction with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidance
Benefits
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible.
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Recent News
2026-01-16
Pharmaceutical Technology
2026-01-16
2026-01-16
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