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Astellas Pharma Associate Director, Pharmacometrics in Northbrook, Illinois

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company. Astellas is announcing an Associate Director, CPED Pharmacometrics opportunity. Purpose & Scope: * Provide scientific, technical, and strategic pharmacokinetic-pharmacodynamic modeling and simulation (M&S) support within and across Tas * Creation of scientific reports to document modeling activities and support registration * Writing of regulatory documents and interaction with regulatory agencies * May act as a Clinical Pharmacology core team member and leading Clinical Pharmacology Extended Teams Essential Job Responsibilities: * Perform pharmacokinetic-pharmacodynamic modeling and simulation using a variety of software, which may include NONMEM, R, and SAS * Peer review of M&S reports and analyses * Make summaries and presentations of analyses to others * Manage and oversee outsourced projects * Contribute to the design, analysis, and reporting of clinical studies for a compound and to provide M&S input to the clinical development strategy * Act as the M&S representative on Core Teams, Extended Teams, Early Modeling Teams, and the Quantitative Quartet * Be actively involved in strategic modeling discussions with other pharmacometricians, and PBPK and QSP modelers * Represent M&S for in-house discovered or in-licensed compounds, which may include Due Diligence activities * Preparation of various sections of regulatory documents, such as IB, IND, and CTD,, and interaction with regulatory agencies * May lead various working groups or initiatives to improve internal processes or best practices * Maintain knowledge of a particular disease area and M&S in general to ensure availability of state-of-the art knowledge and experience in pharmacometrics for practical application in clinical development * Mentoring of junior M&S scientists * May act as a Clinical Pharmacology core team member and leading Clinical Pharmacology Extended Teams Quantitative Dimensions: * Responsible for the design, analysis, and reporting of all M&S analyses associated with 3 to 10 projects per year with 1 to 4 projects at any given time * Responsible for management of timelines of M&S analyses related to particular studies * Responsible for management of costs and timelines of outsourced M&S analyses * May coach 1 to 2 new staff members on company and project team related procedures within Pharmacometrics and CPED * Responsibilities may directly impact on strategy and efficiency of clinical development of compounds * May create 10 to 25 modeling reports per year * The position has no direct budget responsibility Organizational Context: * This position reports to the Pharmacometrics US Group Lead * This position has no direct reports * Direct interaction with the Quantitative Quartet (clinical, statistics, clinical pharmacology science), extended CPED team members, and core team partners Qualifications: Required: * Advanced degree MD/ PhD /PharmD required * Requires at least 5 years post-graduate PhD experience or 9 years post-MS in the pharmaceutical industry with a good understanding of drug discovery and development * Ability to integrate knowledge across all CPED functions * Theoretical and working understanding of modeling and simulation of pharmacokinetic- pharmacodynamic data * Through understanding of pharmacokinetic-pharmacodynamic principles and how they are applied to clinical pharmacology * Basic understanding of disease biology and exposure-response M&S required to design early development strategies up to and including PoC * Expert working and theoretical knowledge of population pharmacokinetic-pharmacodynamic modeling methodologies and software * Working knowledge of Microsoft Office * Working knowledge with graphics software or tools * Working knowledge of a programming language such as SAS or R * Working understanding of regulatory strategies and guidelines * Experience in regulatory filings, eg., IND, IMPD, NDA, etc, and interactions with regulatory authorities worldwide * Good written and communication skills * Strong, critical analytical mind * Ability to operate with minimum of supervision #LI-VB #LI-Remote Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Category Clinical Pharmacology and Exploratory Development