Senior Level PK/PD Position
Zoetis - a global animal health company dedicated to supporting its customers
and their businesses.
Location: Kalamazoo, Michigan
Pharmacokinetic-Pharmacodynamics Associate Research Director/Research Director
Position Summary
We are seeking a talented senior scientific leader to join our team to discover
novel therapeutics for veterinary medicine. This position will require 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
pharmacokinetics, 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
projects. This position will require supervisory responsibilities of
scientific colleagues.
Responsibilities
* Independently design, conduct and analyze analytical data for in vivo
TK, PK and PK/PD studies in multiple veterinary species for large molecule and
small molecule therapeutics which are appropriate to support regulatory
submissions
* Provide PK/PD modeling, bioanalytical and translational science
guidance to projects to help select lead candidates and optimize dose regimens
* Supervise, train and mentor other scientists supporting large
molecule and small molecule therapeutic projects
* Work collaboratively with interdisciplinary teams to prosecute
studies and projects in line with the strategic direction of the team
* Serve as study director or principal investigator, including writing
protocols and reports for in vivo studies, including GLP studies
* Present results to scientific teams, management, and regulatory
agencies
* Write sections of regulatory submissions, respond to inquiries from
regulatory agencies, and maintain knowledge of regulatory guidance documents
Minimum Qualifications
* PhD in Pharmacology, Biochemistry, or related discipline with a minimum
of 12 years of industry experience in PK/PD, bioanalytical and/or translational
sciences of small or large molecules.
* Demonstrated ability to provide PK/PD modeling support for in vivo
studies, 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 small
molecule analyses, including ligand binding assays (immunoassays) and LC/MS/MS
assays.
* Familiarity of immunogenicity risk assessments, testing and
interpretation for large molecule therapeutics.
Desirable skills
* Working knowledge of principles and concepts in adjacent disciplines
for biotherapeutic projects (toxicology, formulation, molecular biology,
protein expression/purification)
* Experience developing population PK models and/or evaluating PK
variance in clinical populations
* Experience with radiolabeled (14C and/or 3H) drug disposition studies
* Experienced with LIMS software, such Watson.
* Experienced with monitoring work at CROs
Apply at Zoetis.com
Position: JR00000911