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.