NONMEM Users Network Archive

Hosted by Cognigen

new role in bay area

From: Brenda Roseberry <broseberry>
Date: Fri, 31 Jul 2020 14:50:18 +0000

New roles available, bay area CA, level flexible. Relo provided, also flexi=
ble during COVID. Please email me for more info at broseberry
com<mailto:broseberry


This position will assist in developing and applying clinical pharmacology =
and translational medicine strategies for candidate drug products including=
 from FIH through late stage development and regulatory filing.
* Represent clinical pharmacology on cross-functional project t=
eams involved in the clinical development of candidate drug products.
* Collaborate with cross functional teams for the optimal desig=
n of Phase I-IV studies; contribute to the clinical study protocols and rep=
orts.
* Work closely with sample management and bioanalytical.
* Assist in integrating and interpreting nonclinical and clinic=
al pharmacology, DMPK, and translational medicine pricniples in the prepara=
tion of clinical pharmacology write-ups and regulatory documents (IND, IMPD=
, IB, NDA CTD, etc).
* Create and manage of datasets such as non-compartmental and =
compartmental PK/PD analysis.
* Collaborate with pharmacometricians in the modeling of emergi=
ng PK and PK/PD data.
* Participate in writing publications and making scientific pre=
sentations consistent with development strategies.
* Maintain knowledge of relevant scientific and regulatory prac=
tices and trends, and ensure that clinical pharmacology aspects of developm=
ent programs are contemporary. Other duties as assigned.

A Pharm. D. or PhD in a scientific discipline is required. Post-doctoral w=
ork may serve as experience. non-PhDs with demonstrated capabilities and/or=
 significant experience may also be considered. Must be able to demonstrate=
 significant success in technical proficiency, scientific creativity, colla=
boration with others and independent thought and be able to clearly commun=
icate scientific and technical information both written and oral. Experienc=
e working in an regulated environment and experience and understanding of I=
CH, and GCP is highly desired. Must have hands-on experience with data anal=
ysis, non-compartmental and compartmental PK/PD and using data processing s=
oftware such as Phoenix WinNonlin, R, NONMEM, etc. Good working knowledge o=
f graphing software is also desired.




[cid:1.1213385771
Brenda Roseberry
   Division Manager-Scientific
   Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers
    720-328-9526 - Office
    315-415-4353 - Mobile
    720-475-1176 - Fax
   [cid:image001.png
ew?id=19937880&authType=name&authToken=b5d_>



image001.png
(image/png attachment: image001.png)

image002.png
(image/png attachment: image002.png)

Received on Fri Jul 31 2020 - 10:50:18 EDT

The NONMEM Users Network is maintained by ICON plc. Requests to subscribe to the network should be sent to: nmusers-request@iconplc.com.

Once subscribed, you may contribute to the discussion by emailing: nmusers@globomaxnm.com.