Open Position at Astellas: Associate Director/Senior Manager in PKMS

Astellas is a bright spot in the pharmaceutical industry, not just because of what we do, but in the way we do it. At a time when many pharmaceutical companies are down-sizing, Astellas is growing. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine. We offer a different kind of work culture. A high standard of ethics is mandatory. Quality is our pledge. Diversity is valued. Individual initiative is rewarded. Astellas offers an environment where our employees can make a real difference. Come, shine with us! Astellas is hiring for an Associate Director/Sr Manager the Pharmacokinetics, Modeling, & Simulation group in our Northbrook, IL location. Responsibilities: Participate in the development and review of Clinical Development Plans, focusing on the characterization of basic PK characteristics, identification of potentially critical issues (e.g. interaction potential), characterization of the time course of pharmacological responses, and the relationship between these responses and the PK characteristics of the NCE, clearly distinguishing between what is required and what is useful. Participate in a study team responsible for the design, execution, and reporting results of a clinical study. In collaboration with other members of the study team contributes to the design of a study with respect to selection of treatments and dose regimen, sampling schedules for PK and PD measurements, selection of PK and PD responses, methodologies for PK-PD analysis, and statistical analysis of these data, carefully balancing what is scientifically justifiable and practically feasible; ensure smooth and safe execution by providing interim PK-PD analyses where necessary; perform the final analysis, and write the PK-PD related sections of the protocol, Statistical Analysis Plan (SAP), and report. Participate in the review, analysis and interpretation of non-clinical pharmacokinetic (PK) (incl. toxicokinetic) and pharmacodynamic (PD) data to facilitate the transition from the pre-clinical to the clinical phase. This may include extrapolation of data obtained in in-vitro and animal models to man (e.g. by allometric scaling), interpretation of data on metabolism and transporters, identification of the relation between PD effects and PK characteristics. Perform PKMS analyses independently using noncompartmental methods using the Phoenix platform and to critically review (including quality control checks) results of PK-PD analyses performed by others (internal and external). Work with CROs for outsourcing of PK-PD work, clearly defining the contents of the outsourced package (e.g. work to be done, requirements for reporting) and keeping track of the progress of the work, quality of the deliverables, and time lines. Use advanced methods of PK-PD analysis and simulation including compartmental and population methods to independently perform data analysis using standard software packages like NONMEM and supportive software like Monolix, R, or SAS. To effectively describe, interpret, and communicate with internal teams, external teams, and outside experts the results of the PK-PD analyses, distinguishing between what is certain, probable, possible and unlikely. Participate in due diligence activities to critically assess PK and PD documents. Participate in the writing of regulatory documents like IND, CTD, PIPs, and DSURs. Position Requirements Education: Ph.D. background with proven publication skills or MS with equivalent working experience preferred Experience: At least 6 or more years industry experience for Associate Director; 3 or more years for Senior Manager Good command of English; both oral and written Good general communication and organizational skills Ability to work independently and be a good team player at the same time Extensive experience with NONMEM and post-processing data analysis using either R or S-Plus Good working knowledge of relevant regulatory requirements for clinical studies in the USA Good computer skills Ability to represent Astellas at internal and external meetings To apply online use the URL https://www.candidatecare.com/srccsh/RTI.home?r=5000005425610&c=883&d=astellas.candidatecare.com&_dissimuloSSO=ylEa1-dr9Gw:KdsvChO-NVf0azSxh22WVQG8O6w If you have any questions, please contact Peter Bonate directly. Peter L. Bonate, PhD Senior Director Global Head - Pharmacokinetics, Modeling, and Simulation Global Clinical Pharmacology & Exploratory Development Astellas 1 Astellas Way, 2N.184 Northbrook, Il 60062 phone: 224-205-5855 fax: 224-205-5914 email: [email protected]<mailto:[email protected]> If not now, then when? If not me, then who? Mick Ebeling. Inventor.