NONMEM Users Network Archive

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Director/Senior Director, Pharmacometrics role available

From: Brenda Roseberry <broseberry>
Date: Fri, 18 Dec 2020 15:28:49 +0000

A new role with a pharmaceutical client is available. Location is open to r=
emote, NJ, MA, or MD. Please let me know if interested and email: broseberr=
y
Oversees all clinical pharmacology and pharmacometrics activities related t=
o pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. Leads study=
 design, execution and reporting of clinical pharmacology and studies and p=
harmacometrics analyses and reports. 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 non-cl=
inical and bioanalytical team members for design and execution of first-in-=
human, mass balance and drug interaction studies. Author/reviewer of clinic=
al pharmacology submission documents and representative of the department a=
t different product development team meetings. Lead pharmacometrics and sim=
ulation and modeling team members and provide input on modeling and simulat=
ion activities. Interacts with early development and business development t=
eam members as well as external collaborators to assess/lead development an=
d selection of pre-IND and early phase assets.

Job Description
* Lead clinical pharmacology activities related to study design,=
 protocol development, study execution, reporting and interpretation of dat=
a.
* Conduct PK and PK/PD analysis.
* Conduct pharmacometrics analyses or work closely with pharmaco=
metrics team members and lead activities related to analysis and reporting =
of PK and PK/PD.
* Lead development of clinical pharmacology sections for regulat=
ory filings including annual reports, investigator's brochure, IND/NDA appl=
ications and pediatrics development plans.
* Work with bioanalytical team members on activities related to =
assay development, sample management, pharmacogenomics and biomarker develo=
pment.
* Work with formulation development groups and provide support f=
or activities related to formulation development, dissolution testing, in v=
ivo-in vitro correlations and biowaivers for pre- and post-approval formula=
tions.
* Manage clinical pharmacology activities related to project bud=
gets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and a=
pproval of invoices.
* Training and mentoring of staff.
* Serve as clinical pharmacology and pharmacometrics leader on m=
ultiple project teams

Qualifications
Knowledge, Skills, and Competencies
* In-depth knowledge of clinical pharmacology, pharmacokinetics, pharmacody=
namics, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
Hands on pharmacometrics, PK/PD and statistical analysis using NonMEM, Phoe=
nix NLME etc.
* Excellent working knowledge of phase I clinical operations, drug developm=
ent, multi-region regulatory requirements and PK/PD analysis.
* Great working knowledge of formulation development, drug development and =
clinical development.
* Current awareness of the latest developments in clinical pharmacology, ph=
armacometrics and guidance documents.



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Brenda Roseberry
   Division Manager-Scientific
   Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers
    720-328-9526 - Office
    315-415-4353 - Mobile (preferred)
    720-475-1176 - Fax
   [cid:image002.png
-roseberry-1608166/?msgConversationId=6641167769234657280&msgOverlay=tr=
ue>



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Received on Fri Dec 18 2020 - 10:28:49 EST

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