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Amgen Director - Modeling and Simulation in Thousand Oaks, California

Amgen is a values based organization with a powerful sense of shared purpose toward our mission: to serve patients. We encourage our team members to have fulfilling and meaningful careers through challenging assignments and career development.

Biotechnology opened the door to new types of medicines based on nature’s own building blocks. No company has done more to advance this revolution than Amgen and our broad toolkit of drug modalities just got larger. Learn more at www.amgenscience.com/the-shape-of-drugs-to-come . As part of this commitment, Amgen’s Clinical Pharmacology, Modeling and Simulation Department is seeking a Director, Modeling and Simulation to be based at our Thousand Oaks campus.

Job Summary

The Director will be responsible for the development and implementation of the modeling and simulation strategies and execution of tasks for clinical development candidates across multiple novel modalities including T-cell engagers, cellular and nucleic acid based therapies in addition to monoclonal antibodies and small molecules. Key responsibilities include leading a team of modelers responsible across multiple therapeutic areas for:

  • Conducting PK/PD and exposure-response analyses of data from early to late phase clinical studies using pharmacostatistical and relevant state of the art modeling and simulation techniques

  • Performing meta-analysis using proprietary and/or literature data

  • Participating in cross-functional project teams and providing scientific input for dose selection for early and late stage clinical study designs using quantitative methods

  • Contributing to clinical pharmacology plans by establishing and implementing high impact modeling and simulation strategy for clinical development candidates

  • Authoring PK/PD reports and contributing to summary documents for regulatory submissions.

Basic Qualifications

Doctorate degree and 4 years of Biotechnological Modeling and Simulation experience

OR

Master’s degree and 8 years of Biotechnological Modeling and Simulation experience

OR

Bachelor’s degree and 10 years of Biotechnological Modeling and Simulation experience

Preferred Qualifications

  • PhD in applied (bio)statistics, (bio)engineering, applied biomathematics/biophysics or related fields with equivalent professional degrees

  • 10+ years of experience as Modeling & Simulation scientist in the Biotechnology/ Pharmaceutical Industry.

  • Experience mentoring and supervising junior modelers

  • Deep understanding of clinical pharmacology and early and late phase clinical development

  • Expertise and past hands-on experience analyzing pharmacokinetic, efficacy and safety data from clinical trials using advanced pharmacometric or statistical modeling methodologies and conducting clinical trial simulations to assist study design

  • Expertise in standard pharmacometric software (e.g. NONMEM, R, SAS, MATLAB) and programming languages

  • Expertise in binary and categorical data analyses, time-to-event (hazard) models, Poisson models, logistic regression, MCMC and Bayesian methods as applied to exposure-response analyses, meta-analyses and Population PK and PKPD analysis

  • Expert knowledge in developing modeling analysis plans, population PKDPD and translational modeling strategies, developing clinical study designs and dose optimization

  • Track record of regulatory filings (NDA/BLA) and responding to regulatory agency questions and knowledge of global regulatory requirements and guidances on quantitative analyses

  • Experience guiding the development/maintenance pharmacometric infrastructure, justifying and implementing innovative pharmacometric software/tools, leading innovative methodology/algorithm development for modeling and simulations, and organizing trainings and educations to embrace cutting-edge technologies in pharmacometrics

  • Experience recognizing and anticipating discovery/translation/development problems that can be addressed by applying quantitative methods and finding effective solutions in partnership and collaboration with cross-functional teams to enable decision-making. Track record of influencing a broad spectrum of stakeholders toward achieving business goals

  • Excellent interpersonal, verbal and written communication skills and the ability to function in a highly matrixed team environment are essential.

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

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.​

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