Scientific Associate Director - PKDM (Small Molecule Modeling and Simulation)

Career Category

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. 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.

Scientific Associate Director - PKDM (Small Molecule Modeling and Simulation)

What you will do

Let’s do this. Let’s change the world. In this vital role you will characterize the absorption, distribution, metabolism, excretion and pharmacokinetic (ADME) properties of small molecule drug candidates to achieve their full pharmacological potential. In this role, your core responsibilities include leading strategically and scientifically a team of pre-clinical PKPD and PBPK modelers responsible for:

• Planning and execution of mechanistic PKPD analyses to integrate knowledge of drug design parameters, disease pharmacology, physiology, pharmacokinetics and pharmacodynamics, and to optimize compound properties, dose-selection and preclinical study designs

• Working closely with discovery scientists (biologists, translational scientists, medicinal chemists, biochemists, pharmacologists, toxicologists) to codify their knowledge and discover new insights using advanced PKPD modeling techniques

• Characterizing drug-target interactions by pharmacologically and toxicologically. This includes but is not limited to characterizing the risk for drug-drug interactions

• Contributing to the analysis of pre-clinical PKPD data for IND and NDA filings, and documentation in appropriate reports.

• Work closely with business development group to evaluate external opportunities

• Build close relationships with partner functions and therapeutic areas in addition to leading the quantitative pharmacology team

• Responsible for ensuring robust translation understanding of PK and PD from pre-clinical to clinical through partnership between PKDM, the Clinical Pharmacology & Modeling and Simulation, and Precision Medicine teams

• Contribute to developing and driving strategy within PKDM and growing visibility & impact cross-functionally

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek will possess 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 Pharmacokinetics, Pharmaceutical Sciences, Engineering, or related fields with equivalent professional degrees and 10+ years of experience in the Biotechnology/Pharmaceutical Industry, consulting or post-doctoral training.

• Expertise in computational and mechanistic PK/PD, PBPK and translational modeling

• Experience in supporting preclinical/clinical PK, PK/PD, and modeling & simulation components of regulatory documentations.

• Excellent interpersonal, technical, and communication skills to lead cross-functional teams

• Past experience as a laboratory scientist and in a biotech environment

• Excellent written and oral communication skills, attention to detail and accuracy, and interpersonal skills

• Record of scientific contributions through peer-reviewed articles and external presentations

• Strong background in integrating preclinical data sets to aid in the development of translational PK/PD models for small molecules.

• Proven technical expertise in quantitative pharmacology and strong hands-on modeling and simulation experience with Pheonix WinNonlin, R, SimBiology, SimCYP, GastroPlus and/or other modeling and simulation software and data visualization tools.

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