Director, Clinical Pharmacology role available-New Jersey-please contact me for
more info: brosebe...@cartermackay.com<mailto:brosebe...@cartermackay.com>
Actively participates and contributes to the study design and reporting of
Clinical Pharmacology studies. Provides input into all phases of drug
development including, but not limited to, dose finding, dose optimization,
exposure-response and pediatric development. Closely interacts with nonclinical
and bioanalytical team members for design and execution of first-in-human, mass
balance and drug interaction studies. Author or reviewer of Clinical
Pharmacology submission documents and representative of the department at
different product development team meetings. Works closely with Modeling team
members to provide input on modeling and simulation activities. Interacts with
early development, business development team members as well as external
collaborators to assess/lead development and selection of pre-IND assets.
Job Responsibilities
* Development and review of protocol outlines, protocols, pre-study, during
study and post-study clinical activities
* PK and PK/PD study design, analysis and reporting, including Executive
Summaries for PK and PK/PD studies.
* Work with pharmacometricians on Population PK/PD design, analysis and
reporting
* Development of relevant sections for regulatory filings including Annual
updates, IB updates, Investigational New Drugs and New Drug Applications
* Authoring, review and defense of regulatory submissions
* Works with Bioanalytical team members on design and execution of
first-in-human, mass balance and drug interaction studies, selection of
biomarkers
* Works with formulation development groups
* Manages Clinical Pharmacology activities including:
* Providing input into project budgets including annual and quarterly
budgeting/forecasting.
* Manages outsourcing of PK and PK/PD analyses and reports, including
contract requisition, SOW and approval of invoices.
Education and Related Experience
PhD in Pharmacokinetics, Clinical Pharmacology, Pharmacology, or a related area
with 7+ years of experience in these areas. PharmD with relevant experience
considered
Requires a depth of knowledge in clinical pharmacology including
pharmacokinetics, pharmacodynamics, drug metabolism, biopharmaceutics, and
bioanalytical chemistry.
* Working knowledge of Phase I clinical operations, pharmacometrics,
general pharmacology, pharmacogenetics, and regulatory requirements related to
clinical pharmacology.
* Knowledge of nonclinical requirements and bioanalytical assays for
clinical trials
* Working knowledge of formulation development, drug development, PK/PD
modeling and simulation.
* Understanding of the company's products and the pharmaceutical industry
in general.
* Familiarity with pharmacogenomics in drug development.
* Keeps refreshed of the latest developments in clinical pharmacology.
* Must be able to apply scientific knowledge (in the areas specified above)
to further the company's products, anticipate and identify core problems, apply
insightful analysis, and solve problems effectively.
* Strong organization and communication skills.
* Experience with regulatory submission process (IND, NDA, MAA)
* Hands-on experience with modeling and simulation software (R, NONMEM,
Phoenix NLME, Monolix) desirable.
* Flexibility to react rapidly to changing situations/environment
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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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