I have a new pharmacometrics role available. Ideally we would like some
industry or FDA or equivalent experience. Someone finishing a postdoc will be
fine. Exceptional recent grads also considered as will more experienced
candidates. Level commensurate with experience, title flexible. Role is
hybrid/onsite in San Diego. Please let me know if interested or have a
referral. Email is brosebe...@cartermackay.com
This role is for a Sr. or Principal Scientist with in a pharmacometrics group
applying MIDD strategies in drug development. Will conduct PK/PD modelling and
simulation in support of programs in all stages of clinical development. Will
present modelling and simulation analyses to internal project teams and may
present to external colleagues or regulatory agencies. This individual will
work with experienced cross functional teams and have mentorship from senior
team members.
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Responsibilities:
* Serve as subject matter expert in pharmacometrics and represent the
Pharmacometrics Group on matrix teams
* Will lead the MIDD and Pharmacometrics strategies to support dose
selection, trial design and regulatory submissions on assigned programs
* Will oversee CRO partners/vendors
* Independently conduct hands on PK/PD analyses of data from early phase
studies and application of quantitative decision-making to assist in population
PK, dose- and exposure-response relationships to optimize subsequent clinical
development
* Communicate and interpret modeling results to project teams. Accountable
for ensuring appropriate design and implementation of pharmacometrics plans
* Collaborate with other colleagues to review and validate M&S outputs such
as datasets and modeling programs
* Prepare posters, publications, presentations for internal and external
conferences
Requirements:
* PharmD or PhD or equivalent preferred and 1+ years of relevant
experience; may include postdoc experience(level commensurate with experience)
* MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry,
Biochemistry, or related field with a specific focus on PK and PK/PD modeling
and simulation and 10+ years of Pharmaceutical/Biotech industry experience in
conduct and/or oversight of late-stage Modeling and Simulation activities,
including conduct or oversight of small molecule population pharmacokinetic
analyses. Experience in the preparation of components of the Clinical
Pharmacology sections of Regulatory submissions for IND- and NDA-stage projects
OR
* Demonstrated foundation of scientific knowledge (e.g., basic
pharmacokinetic/pharmacodynamic [PK/PD] and pharmacology concepts) and
technical pharmacometrics skills including but not limited to nonlinear mixed
effect modeling, mechanistic PK/PD, physiologically-based pharmacokinetic
(PBPK), quantitative systems pharmacology (QSP) modeling and clinical trial
simulations
* Competent in using modeling tools for population PK, PD analysis (e.g.,
NONMEM, Monolix, Simcyp, R packages for nonlinear mixed-effects modeling)
* Proactive, innovative, with good problem-solving skills
* Able to take different pharmacometrics assignments and deliver the
results promptly
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Brenda Roseberry
Vice President, Scientific Recruiting
Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers
315-415-4353 - Mobile
