Clinical Pharmacology Modeling and Simulation - Principal Scientist

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Clinical Pharmacology, Modeling & Simulation- Principal Scientist

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What you will do

Let’s do this. Let’s change the world. The Clinical Pharmacology, Modeling & Simulation Department at Amgen is seeking a Principal Scientist at its Thousand Oaks, CA location. In this vital role you will be responsible for clinical pharmacology components of one or more general medicine clinical program (cardiovascular, metabolic, neuroscience, bone, nephrology, inflammation, or hematology disease areas), including study design, protocol preparation and reporting. In this vital role you will integrate results into regulatory filings and product labels. Possess understanding of PKPD modeling concepts and their application to dose selection, study design, risk/benefit, and informing drug development decisions in close collaboration with other R&D partners.

Key Responsibilities

• Plans all necessary non-compartmental analyses to support project team decisions, publications, and reporting.

• Designs clinical pharmacology components of drug development project clinical plans and provides clinical pharmacology expertise to project teams including plan, design and oversight of clinical pharmacology studies.

• Implementing clinical pharmacology standard methodologies consistently.

• Planning and implementation of PKPD analyses to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs.

• Contributes to the analysis of pre-clinical PKPD data for selection of FIH dose levels. Ensures adequate safety margins exist for selected dose levels.

• Preparation of clinical pharmacology contributions to regulatory documents including Investigator Brochures, EOP2 meetings, IND, NDA/BLA. Leads resolution of clinical pharmacology queries from drug regulatory agencies, contributes in writing and reviewing responses to regulatory queries.

• Plans timing for, designs, leads, and may act as clinician for healthy volunteer phase I and dedicated Clinical Pharmacology studies including (but not limited to) SAD/MAD, DDI, Food-Effect, ADME, Hepatic/Renal Impairment, BA/BE, and PK bridging.

• Contribute recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the clinical and Development teams and in regulatory documentation.

• Influences external environment through methods such as publication and presentations.

• Collaborating with partner lines (e.g. clinical assay group, statistics, pharmacometrics) to ensure appropriate support for assigned programs and studies

• This position is based in Amgen, Thousand Oaks site and candidates that can be based at this site are preferred. Amgen also offers flexible work models including working from home options and consideration can also be given to qualified remote candidates.

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What we expect of you

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 2 years of Clinical Pharmacology and Modeling & Simulation experience OR

• Master’s degree and 5 years of Clinical Pharmacology and Modeling & Simulation experience OR

• Bachelor’s degree and 7 years of Clinical Pharmacology and Modeling & Simulation experience

Preferred Qualifications:

• PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or 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, M-PBPK modeling, M-PBPK-PD modeling, and QSP modeling to inform clinical study designs, optimal dosage selection in target patient populations, characterization of drug-drug inter