Scientific Associate Director - Clinical Pharmacology, Modeling & Simulation

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.

Scientific Associate Director - Clinical Pharmacology, Modeling & Simulation

Live

What you will do

Let’s do this. Let’s change the world. In this vital role, you will be responsible for the development and implementation of the Modeling and Simulation strategies and the use of innovative modeling methods including mechanistic modeling, data science and predictive analytics to support drug development.

The Scientific Associate Director will also work collaboratively with other functional areas within Amgen such as clinical pharmacology, digital health, pharmacokinetics and drug metabolism, and clinical biostatistics. Additional responsibilities include leading/executing in a wide range of activities such as creating complex analysis datasets from diverse sources, implementing/developing/recommending novel machine learning tools, data visualizations, quantitative pharmacometric models, disease progression models, mechanistic and empirical Pharmacokinetic-Pharmacodynamic (PK/PD) models, clinical trial simulations, literature meta-analysis using quantitative approaches and statistical modeling of historical and preclinical data. The candidate is expected to be able to integrate modeling and simulation results into the communication channels across cross functional teams, regulatory agencies and apply them for justification of dose selection, study design, risk/benefit, and advising drug development decisions in close collaboration with other R&D partners.

Key Responsibilities:

• Design modeling and simulation and analytics components of clinical drug development plans and provide expertise to project teams including planning, design, execution and oversight of M&S plans for multiple programs in Amgen portfolio.
• Responsible for planning and implementation of analyses to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs.
• Contribute to the analysis of in-vitro and pre-clinical PK/PD data for selection of first in humans (FIH) dose levels and contributes to IND submissions and documentation of appropriate reports.
• Contribute to 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.
• Influence external environment through methods such as publication and presentations.
• Responsible for collaborating with partners (e.g. clinical pharmacologists, clinical assay group, statistics) to ensure appropriate support for programs and studies.
• Provide thought leadership, guidance and advice in own field, and develop innovative and creative output based on interpretation and analysis including mentoring junior staff

Win

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 PhD OR PharmD OR MD [and relevant post-doc where applicable] and 4 years of relevant experience

Or

Master’s degree and 7 years of relevant experience

Or

Bachelor’s degree and 9 years of relevant experience

Preferred Qualifications:

• PhD in Statistical and Data sciences, Computer Science, Pharmaceutical Sciences, Engineering, or related fields with equivalent professional degrees (e.g. MD, PharmD), and 5+ years experience in the life sciences, Biotechnology/Pharmaceutical Industry, consulting or post-doctoral training
• Experience in PK/PD modeling and population-based analyses/simulations with established track-record of model-based drug development in multiple therapeutic areas will be an advantage
• Demonstrated experience with scripting and implementing data analytics algorithms and models. Hands on experience using a modeling and simulation software (e.g. Python, Matlab, R, Julia, NONMEM, SAS, S-Plus, etc) is a plus
• Excellent interpersonal, technical, and communication skills to lead cross-functional teams
• Previous record of scientific contributions through peer-reviewed articles and externa