Director, Modeling and Simulation (Oncology)

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, career development, and valuable opportunities such as this.

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 & the company's broad toolkit of drug modalities just got larger www.amgenscience.com/the-shape-of-drugs-to-come . The Clinical Pharmacology, Modeling & Simulation Department at Amgen (South San Francisco, CA) is seeking a Director, Modeling and Simulation.

Responsibilities:

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 and cellular therapies in addition to monoclonal antibodies and small molecules. Key responsibilities include leading a team of modelers responsible across multiple indications in the oncology therapeutic area 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 Modeling & Simulation scientist in the Biotechnology/ Pharmaceutical Industry
OR
Master's degree and 7 years of Modeling & Simulation scientist in the Biotechnology/ Pharmaceutical Industry
OR
Bachelor's degree and 9 years of Modeling & Simulation scientist in the Biotechnology/ Pharmaceutical Industry

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
• Significant experience in oncology modeling
• 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

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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.

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