[NMusers] Sr/Prin Pharmacometrician Job Opportunity at MedImmune California or Maryland Headquarters

From: Wang, Bing <WangBI_at_MedImmune.com>
Date: Mon, 29 Aug 2016 19:42:23 +0000

My company shares my passion for helping to improve human health around the=
 world.




"This is My MedImmune"



Those who join MedImmune feel a sense of ownership about their future. They=
 thrive with a recognized leader in the biotechnology industry and the whol=
ly-owned subsidiary of AstraZeneca plc. Here, you will join passionate prof=
essionals who advance science, technology and medicine to develop products =
designed to help people live better lives. You will excel in an environment=
 characterized by respect, integrity and growth opportunities... that encou=
rages both individual contribution and collaborative entrepreneurial thinki=
ng. Our products and/or product candidates are designed to address areas of=
 need in key therapeutic areas, including oncology; respiratory, inflammati=
on and autoimmunity; cardiovascular and metabolic disease; and infection an=
d vaccines. Explore a MedImmune career as we strive to better more lives, m=
ore often, around the world.



Title

Senior Pharmacometrician / Principal Pharmacometrician






Location

CA, Mountain View
MD, Gaithersburg - Corporate Headquarters

Job Description

This position can be filled at either the Senior Pharmacometrician or Princ=
ipal Pharmacometrician level depending upon experience. This position can b=
e based in Mountain View, CA or Gaithersburg, MD.

This is a strategic and scientific role within Clinical Pharmacology & DMPK=
 (CPD), which provides nonclinical and clinical PK/PD, pharmacometrics and =
bioanalytical support for biotherapeutics projects at all R&D stages from d=
iscovery research to BLA registration and commercialization.

The pharmacometrician will conduct advanced population modeling and stochas=
tic clinical trial simulations for late-stage biotherapeutics projects. In =
collaboration with clinical pharmacokineticists, statisticians and physicia=
ns, the pharmacometrician will work as a partner in cross-functional projec=
t teams providing sophisticated M&S support for clinical dose recommendatio=
n, optimal trial design, rational development decision making, and regulato=
ry filings.

Major Duties and Responsibilities:

* Leverage M&S expertise to address key clinical development questions. Pro=
vide strategic input into clinical development plans. Responsible for the M=
&S components in late-stage trial designs and data interpretation.
* Use innovative quantitative approaches to integrate knowledge of PK, PD, =
efficacy, safety, patient demographics, and pathophysiological factors to f=
acilitate product development decision making. Perform mechanistic PK-PD an=
d disease modeling to establish dose-exposure-response relationship.
* Contribute to the regulatory submission packages, and participate in regu=
latory meetings as appropriate. Interact with clinical pharmacokineticists =
and monitor outsourced modeling activities to ensure quality of the work an=
d timely delivery of the results.
* Utilize published external data to enhance the knowledge of diseases and =
treatments, and to facilitate the development of internal drug candidates.
* Actively promote MedImmune as a biopharmaceutical leader in the utilizati=
on of quantitative model-based drug development approach. Support MedImmune=
 publication strategy. Present and report data in approved external confere=
nces and scientific/medical journals.



Position Requirements

Education/Experience

Senior Pharmacometrician
PhD with 2- 5 years of relevant industry experience in pharmacostatistical =
data analysis .

Principal Pharmacometrician
PhD with 5+ years of experience in pharmacostatistical data analysis and re=
gulatory filings.

Skills:
* Demonstrated expertise in pharmacometrics and strong quantitative skills.
* Prior experience in regulatory filings is highly desirable for Sr Pharmac=
ometrician and required for Principal Pharmacometrician
* Proven track record of extensive experience in population modeling and si=
mulations using NONMEM.
* Familiarity with statistical software package Splus, R or SAS.
* Good communication and scientific writing skills, and ability to independ=
ently work in a matrix environment.




Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sex=
ual Orientation

Req ID

11006





Interested candidates please apply online at https://www.medimmune.com/abou=
t-us/careers.html# and use Requisition ID 11006. Thanks.
To the extent this electronic communication or any of its attachments conta=
in information that is not in the public domain, such information is consid=
ered by MedImmune to be confidential and proprietary. This communication is=
 expected to be read and/or used only by the individual(s) for whom it is i=
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k you for your cooperation.


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Received on Mon Aug 29 2016 - 15:42:23 EDT

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