NONMEM Users Network Archive

Hosted by Cognigen

Director, PK & Clinical Pharmacology (ISIS Pharmaceuticals)

From: John Grundy <JGrundy>
Date: Thu, 22 Jul 2010 13:22:28 -0700

ISIS Pharmaceuticals (<>) is seeki=
ng a highly motivated individual for the following position:


This position will report directly to the Vice President (Pharmacokinetics =
and Clinical Pharmacology). The primary responsibilities of this director-=
level position will be to characterize and document the pharmacokinetic (PK=
)/toxicokinetic (TK) properties of new chemical entities in development (bo=
th preclinical and clinical) for various therapeutic areas (cardiovascular,=
 metabolic, oncology, etc.), as well as providing expert TK/PK support to t=
he toxicology and clinical groups at Isis (and our partners). Providing su=
pervision, assistance, and/or mentorship to analysis, report writing, and m=
odel development conducted by other development PK and bioanalytical (BA) s=
cientists is expected. Evaluation of relationships between PK and pharmaco=
dynamic (PD) measures (using graphical techniques and modeling) for compoun=
ds at various stages of development are another responsibility of this posi=
tion. Scientific oversight of selected external CROs providing PK and BA s=
upport for Isis projects/studies is expected. This position conducts, cont=
ributes to, or supervises the planning, writing, reviewing and summarizing =
of preclinical and clinical PK and PK/PD assessments (study protocols, anal=
yses, reports and integrated summaries) for development projects and ultima=
tely for regulatory submissions (e.g., IND, IMPD, IB, annual report, CTD, e=
tc.). This position must work closely with the Project Team to ensure time=
ly and accurate communication of results and provide necessary support and =
expertise to the development of new chemical entities. Contributions are a=
lso expected for improving antisense as a core technology through collabora=
tions with exploratory research PK efforts and with academic laboratories (=
e.g., metabolism research, cellular uptake pathways, oral delivery, etc.). =
 Applicants must possess an excellent working knowledge of the fundamental =
principles of PK and PK/PD analyses for both preclinical and clinical studi=
es, and a good publication record in the field. A working knowledge of GLP=
 requirements for bioanalytical and PK studies is also required.

This is an ideal position for someone who is motivated by the opportunity t=
o contribute (both in direct hands-on and supervisory roles) their skills t=
o pharmaceutical development from research to IND-enabling development and =
through to the design and analyses of Phase 1-3 clinical studies. The succ=
essful applicant will join an established team in the Pharmacokinetics & Cl=
inical Pharmacology group who are leaders in the field of antisense develop=
ment and are internationally recognized for their efforts.

Job Specifications:

* Ph.D. in Pharmacokinetics, Biopharmaceutics, or other related pha=
rmaceutical science

* 8+ years of experience in pharmaceutical or biotech industry

* Experience with multiple regulatory submissions and interactions

* Proven effective management skills

* Familiarity and direct experience with common software tools for =
PK analysis (WinNonlin, NONMEM, SPLUS, etc.)

* Research experience with in vivo and in vitro metabolism studies,=
 and extensive knowledge of various bioanalytical methodologies and procedu=
res, would be a plus

* Excellent oral and written communication skills

* An ability to be productive and successful in an intense work env=

Excellent Salary and Benefits Package Offered.

For more information on Isis and to apply for this position, please visit o=
ur website,<>. Reference Requisi=
tion #298

Received on Thu Jul 22 2010 - 16:22:28 EDT

The NONMEM Users Network is maintained by ICON plc. Requests to subscribe to the network should be sent to:

Once subscribed, you may contribute to the discussion by emailing: