Clinical Pharmacology Modeling and Simulation - Principal Scientist

Amgen • Thousand Oaks, CA

411d • Remote

About The Position

The Principal Scientist in Clinical Pharmacology, Modeling & Simulation at Amgen will play a crucial role in overseeing clinical pharmacology components of various general medicine clinical programs. This position involves study design, protocol preparation, and regulatory documentation, with a focus on pharmacokinetics and pharmacodynamics modeling to inform drug development decisions. The role requires collaboration with cross-functional teams to ensure the successful execution of clinical pharmacology studies and integration of results into regulatory filings.

Requirements

• Doctorate degree and 2 years of Clinical Pharmacology and Modeling & Simulation experience OR Master's degree and 5 years of experience OR Bachelor's degree and 7 years of experience in Clinical Pharmacology and Modeling & Simulation.
• PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemical Engineering, or equivalent professional degrees (e.g., MD, PharmD).
• 5+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.
• Hands-on experience in Quantitative Clinical Pharmacology approaches with a focus on PK/PD modeling and related methodologies.
• Expert knowledge of commonly used software for PK/PD, M-PBPK, M-PBPK-PD, & QSP modeling.
• Established track record of Model Based Drug Development (MIDD) and interaction with global health authorities.

Nice To Haves

• Experience in leading the design and implementation of clinical pharmacology and biopharmaceutics studies.
• Knowledge of global regulatory requirements and guidance.
• Experience in pediatric and biopharmaceutics studies.

Responsibilities

• Plan all necessary non-compartmental analyses to support project team decisions, publications, and reporting.
• Design clinical pharmacology components of drug development project clinical plans and provide clinical pharmacology expertise to project teams.
• Implement clinical pharmacology standard methodologies consistently.
• Plan and implement PKPD analyses to optimize doses and study designs based on pharmacokinetics and patient characteristics.
• Contribute to the analysis of pre-clinical PKPD data for selection of FIH dose levels and ensure adequate safety margins.
• Prepare clinical pharmacology contributions to regulatory documents including Investigator Brochures and IND/NDA/BLA submissions.
• Lead resolution of clinical pharmacology queries from drug regulatory agencies and contribute to writing responses.
• Plan, design, and lead healthy volunteer phase I and dedicated Clinical Pharmacology studies.
• Contribute recommendations for clinical doses and dosing algorithms to clinical and Development teams.
• Influence the external environment through publications and presentations.

Benefits

• Comprehensive employee benefits package including medical, dental, and vision coverage.
• Retirement and Savings Plan with generous company contributions.
• Life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program or sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans and bi-annual company-wide shutdowns.
• Flexible work models, including remote work arrangements.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree