Dear all, Come work with me (and the incomparable Pete Bonate!) by joining an amazing group of scientists working on exciting drug development projects! We are looking for a Pharmacometrician for our team at Astellas.
Click the link and/or reach out directly: https://astellascareers.jobs/northbrook-il/associate-director-pharmacometrics/417F851575CD44969065DFF6EDAF23A5/job/ 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, Stacey Tannenbaum * 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: * 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 Stacey Tannenbaum, PhD, FISoP Senior Director, Pharmacometrics US Clinical Pharmacology and Exploratory Development Astellas Pharma, Northbrook, IL [email protected]<mailto:[email protected]> Tel: 224-205-5038 Cell/Mobile: 847-830-1598 [https://appsstage.astellas.us/esignature/images/AstellasLogo.jpg]
