Director, Clinical Pharmacology, Modeling and Simulation

Career Category

Research

Job Description

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 the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Director, Clinical Pharmacology, Modeling and Simulation

What you will do

Let’s do this. Let’s change the world. The Clinical Pharmacology, Modeling & Simulation Department at Amgen is seeking a Director at its South San Francisco, CA location. In this vital role you will be responsible for the development and implementation of the Clinical Pharmacology, Modeling & Simulations strategies for the industry leading cutting-edge pipeline of most innovative therapeutic modalities. Amgen’s robust pipeline leverages state-of-the-art science and molecular engineering focused on the pursuit of transformative medicines with large effects in serious diseases.

The Director, Clinical Pharmacology, Modeling & Simulation will be a leader in the field of clinical pharmacology and a Subject Matter Expert. You will be an expert in designing strategic clinical pharmacology, modeling & simulations plans integrated with clinical development plans in support of new drug development across modalities. You will have expertise in designing clinical pharmacology and biopharmaceutic studies. You will be an expert in clinical drug development and will apply Model-Informed Drug Development (MIDD) strategies and approaches together with principles of quantitative clinical pharmacology to ensure optimal drug development. You will represent the Clinical Pharmacology, Modeling & Simulation Department at the global cross-functional drug development teams. You will apply innovative Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches and clinical pharmacology strategies and principles to guide optimal drug development across early to late-stage development programs. Your expertise will include application of Population PK/PD modeling, Physiologically Based Pharmacokinetic (PBPK) modeling, and Quantitative Systems Pharmacology (QSP) modeling to new drug development to ensure development of safe & effective dosing regimens for various patient sub-populations & ensure optimal new drug development.

What you will do

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of Clinical Pharmacology and Modeling & Simulation experience

OR

Master’s degree and 8 years of Clinical Pharmacology and Modeling & Simulation experience

OR

Bachelor’s degree and 10 years of Clinical Pharmacology and Modeling & Simulation experience

In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or equivalent professional degrees e.g. MD, PharmD).

• 8+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.

• Established track-record of designing strategic clinical pharmacology, modeling & simulations plans in support of new drug development across modalities.

• 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 interaction with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidance

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