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Senior Level PK/PD Position

From: Boucher, Joseph F. <joseph.f.boucher>
Date: Fri, 19 Feb 2016 16:06:12 +0000

Zoetis - a global animal health company dedicated to supporting its custome=
rs and their businesses.
Location: Kalamazoo, Michigan

Pharmacokinetic-Pharmacodynamics Associate Research Director/Research Direc=
Position Summary
We are seeking a talented senior scientific leader to join our team to disc=
over novel therapeutics for veterinary medicine. This position will requir=
e a highly motivated and independent leader who can effectively collaborate=
 with other team members to advance projects. Specifically, we are looking=
 for a senior PK/PD leader to provide technical scientific leadership in ph=
armacokinetics, pharmacodynamics, bioanalytical and translational sciences =
for early research and late stage development projects. This position will=
 be primarily responsible for support of large molecule protein therapeutic=
 projects, but will also need to provide some support for small molecule pr=
ojects. This position will require supervisory responsibilities of scienti=
fic colleagues.

* Independently design, conduct and analyze analytical data for in =
vivo TK, PK and PK/PD studies in multiple veterinary species for large mole=
cule and small molecule therapeutics which are appropriate to support regul=
atory submissions

* Provide PK/PD modeling, bioanalytical and translational science g=
uidance to projects to help select lead candidates and optimize dose regime=

* Supervise, train and mentor other scientists supporting large mol=
ecule and small molecule therapeutic projects

* Work collaboratively with interdisciplinary teams to prosecute st=
udies and projects in line with the strategic direction of the team

* Serve as study director or principal investigator, including writ=
ing protocols and reports for in vivo studies, including GLP studies

* Present results to scientific teams, management, and regulatory a=

* Write sections of regulatory submissions, respond to inquiries fr=
om regulatory agencies, and maintain knowledge of regulatory guidance docum=
Minimum Qualifications

  * PhD in Pharmacology, Biochemistry, or related discipline with a minim=
um of 12 years of industry experience in PK/PD, bioanalytical and/or transl=
ational sciences of small or large molecules.
  * Demonstrated ability to provide PK/PD modeling support for in vivo st=
udies, preferably in the area of large molecule protein therapeutics, with =
a proven track record of success including peer reviewed publications.
  * Experience with GLP regulated studies
  * Expert user of PK/PD modeling software such as WinNonlin, NONMEM, etc=
  * Highly independent with the ability to innovate within the discipline
  * Excellent written and oral communication skills
  * Working knowledge of analytical methodology for large molecule and sm=
all molecule analyses, including ligand binding assays (immunoassays) and L=
C/MS/MS assays.
  * Familiarity of immunogenicity risk assessments, testing and interpret=
ation for large molecule therapeutics.
Desirable skills

* Working knowledge of principles and concepts in adjacent discipli=
nes for biotherapeutic projects (toxicology, formulation, molecular biology=
, protein expression/purification)

* Experience developing population PK models and/or evaluating PK v=
ariance in clinical populations

* Experience with radiolabeled (14C and/or 3H) drug disposition stu=

* Experienced with LIMS software, such Watson.

* Experienced with monitoring work at CROs

Apply at
Position: JR00000911

Received on Fri Feb 19 2016 - 11:06:12 EST

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