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New Jersey Director of Clinical Pharmacology role available

From: Brenda Roseberry <broseberry>
Date: Thu, 13 Feb 2020 18:08:47 +0000

Director, Clinical Pharmacology role available-New Jersey-please contact me=
 for more info: broseberry
com>

Actively participates and contributes to the study design and reporting of =
Clinical Pharmacology studies. Provides input into all phases of drug devel=
opment including, but not limited to, dose finding, dose optimization, expo=
sure-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 d=
ifferent product development team meetings. Works closely with Modeling tea=
m members to provide input on modeling and simulation activities. Interacts=
 with early development, business development team members as well as exter=
nal collaborators to assess/lead development and selection of pre-IND asset=
s.
 Job Responsibilities

  * Development and review of protocol outlines, protocols, pre-study, du=
ring study and post-study clinical activities
  * PK and PK/PD study design, analysis and reporting, including Executiv=
e 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 Ann=
ual updates, IB updates, Investigational New Drugs and New Drug Application=
s
  * Authoring, review and defense of regulatory submissions
  * Works with Bioanalytical team members on design and execution of firs=
t-in-human, mass balance and drug interaction studies, selection of biomark=
ers
  * Works with formulation development groups
  * Manages Clinical Pharmacology activities including:
  * Providing input into project budgets including annual and quarterly b=
udgeting/forecasting.
  * Manages outsourcing of PK and PK/PD analyses and reports, including c=
ontract 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 exper=
ience considered
  Requires a depth of knowledge in clinical pharmacology including pharmaco=
kinetics, pharmacodynamics, drug metabolism, biopharmaceutics, and bioanaly=
tical chemistry.

  * Working knowledge of Phase I clinical operations, pharmacometrics, ge=
neral pharmacology, pharmacogenetics, and regulatory requirements related t=
o clinical pharmacology.
  * Knowledge of nonclinical requirements and bioanalytical assays for cl=
inical trials
  * Working knowledge of formulation development, drug development, PK/PD=
 modeling and simulation.
  * Understanding of the company's products and the pharmaceutical indust=
ry 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 ab=
ove) to further the company's products, anticipate and identify core proble=
ms, 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


[cid:image001.png
Brenda Roseberry
   Division Manager-Scientific
   Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers
    720-328-9526 - Office
    315-415-4353 - Mobile
    720-475-1176 - Fax
   [cid:image002.png
ew?id=19937880&authType=name&authToken=b5d_>



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Received on Thu Feb 13 2020 - 13:08:47 EST

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