Dear Friends,
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/Director in the Pharmacokinetics,
Modeling, & Simulation group in our Deerfield, IL or Leiderdorp, The
Netherlands location.
Associate Director/Director- Modeling (PK/MS)
Responsibilities:
To take responsibility for (interim and final) PK-PD data analysis and
reporting of the results according to Astellas specifications and international
guidances.
Perform PKMS analyses independently using non-compartmental methods, either by
using one of the standard PK software packages (e.g. WinNonlin) or by
programming the methods in software packages like SAS, S-plus or R.
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 R, SAS, or S-plus.
To effectively communicate with internal teams, external teams, and outside
experts.
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.
Participate in the development and review of Clinical Development Plans, with
focus on the characterization of the basic PK characteristics, identification
of potentially critical issues (e.g. interaction potential), and
characterization of the time course of pharmacological responses and the
relation 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 and execution of a
clinical study, and reporting of the results. In collaboration with other
members of the study team contribute to the design of a study with respect to
selection of treatments (types of treatment, dosing, dosing frequency and
duration), sampling schedules for PK and PD measurements (number of samples and
timing), selection of PK and PD responses, methodologies for PK and PD analysis
of the data, 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.
Critically review (including quality control checks) of results of PK, PD
analysis performed by others (internal and external).
Describe and interpret the results of the PK, PD analysis, distinguishing
between what is certain, probable, possible and unlikely.
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 the
time lines.
Participate in due diligence activities to critically assess PK and PD
documents.
Participate in writing regulatory documents (e.g. IND, CTD)
Position Requirements Education:
Ph.D. background with proven publication skills or MS with equivalent working
experience preferred
Experience:
At least 6 or more years experience in PK (PD)
Extensive experience with NONMEM and post-processing data analysis using either
R, SAS, or S-Plus
Good working knowledge of relevant regulatory requirements for clinical studies
in the EU and the USA
Good computer skills
Good command of English; both oral and written
Good general communication and organizational skills
Ability to represent Astellas at internal and external meetings
Ability to work independently and be a good team player at the same time
For more information on Astellas or to apply directly, please follow the link
below:
http://astellas.appone.com/frames.asp?R_ID=550644&B_ID=33&fid=1&Ad=&CountryID=3
Thank you,
Peter L. Bonate, PhD
Senior Director
Global Head - Pharmacokinetics, Modeling, and Simulation
Global Clinical Pharmacology & Exploratory Development
Astellas Pharma Global Development
Three Parkway North
Deerfield, IL 60015
phone: (847) 282-5855
cell: 224-619-4901
email: [email protected]
"Prediction is very difficult, especially if it's about the future" - Neils
Bohr, Nobel Laureate in Physics