Manager/ Associate Director role available in Massachusetts, please contact me
for more info brosebe...@cartermackay.com
The Senior Manager/Associate Director of Clinical Pharmacology will be
responsible for all aspects of the clinical pharmacology strategy including
early (Phase 1) and late stage development (Phase 2/3 and NDA filings). This
individual will provide strategic leadership and execution of clinical
development plans that include characterization and prediction of the
pharmacokinetics, pharmacodynamics, and drug metabolism of the drug candidate
in selected preclinical and all clinical areas. This individual will also
provide dose regimen and patient selection rationale.
Responsibilities
* Plan, prepare and review drug development plans and regulatory filings
* Determine scope, design, and planning and analysis of phase 1-4
pharmacokinetic (PK) and pharmacodynamic (PD) studies, and modeling/simulations
required from a drug development and regulatory perspective to take a project
from concept to commercialization. Responsibilities include describing results
of these studies in regulatory documents (IND's NDA's, IB's, etc.)
* Responsible for protocol design, study planning, review, data analysis /
interpretation, and reporting of individual studies implemented to support
clinical pharmacology components of project plans
* Represent Dicerna with regulatory agencies and respond to regulatory
inquires related to DMPK, PK/PD, and clinical pharmacology
* Ensure appropriate PK/PD analysis including population PK, PK/PD modeling
and simulation, meta-analysis, mechanistic modelling, disease state modelling
as required to aid in data interpretation, trial design and/or program
decision-making
* Participate in writing publications and making scientific presentations
consistent with development strategies and publication plan
* Collaborate with preclinical development colleagues on the
scientific/technical aspects of assigned studies from conception through final
report, including protocol development, budget, timelines, sample
handling/processing, bioanalysis (through CRO), and PK data
analysis/interpretation
* Maintain knowledge of relevant scientific and regulatory practices,
guidance and trends, and ensure that clinical pharmacology aspects of
development programs are contemporary
Qualifications
* PhD, PharmD or equivalent training in pharmaceutical sciences,
pharmacokinetics, mathematics, or a related scientific discipline is required
* Minimum of 3 years of experience in clinical pharmacology, clinical PK/PD
or modeling/simulation in the biopharmaceutical industry is required for the
Senior Manager level. A minimum of 6 - 8 years of relevant experience is
required for the Associate Director level
* Extensive understanding and hands-on experience with Modeling and
Simulation (M&S) techniques in drug development (ie. PK/PD, PB/PK, systems
modelling, mechanistic modeling, population PK)
* Experience preparing regulatory documents, such as IND's and NDA's, as
well as prior direct involvement with major regulatory filings
* Partner with CRO's
* knowledge and understanding of Good Clinical Practices (GCP), the
clinical research drug development process, clinical investigational trials,
and corresponding roles and activities
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Brenda Roseberry
Division Manager-Scientific
Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers
720-328-9526 - Office
315-415-4353 - Mobile
720-475-1176 - Fax
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