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products and/or product candidates are designed to address areas of need in key
therapeutic areas, including oncology; respiratory, inflammation and
autoimmunity; cardiovascular and metabolic disease; and infection and vaccines.
Explore a MedImmune career as we strive to better more lives, more 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 Principal
Pharmacometrician level depending upon experience. This position can be 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
discovery research to BLA registration and commercialization.
The pharmacometrician will conduct advanced population modeling and stochastic
clinical trial simulations for late-stage biotherapeutics projects. In
collaboration with clinical pharmacokineticists, statisticians and physicians,
the pharmacometrician will work as a partner in cross-functional project teams
providing sophisticated M&S support for clinical dose recommendation, optimal
trial design, rational development decision making, and regulatory filings.
Major Duties and Responsibilities:
* Leverage M&S expertise to address key clinical development questions. Provide
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
facilitate product development decision making. Perform mechanistic PK-PD and
disease modeling to establish dose-exposure-response relationship.
* Contribute to the regulatory submission packages, and participate in
regulatory meetings as appropriate. Interact with clinical pharmacokineticists
and monitor outsourced modeling activities to ensure quality of the work and
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 utilization
of quantitative model-based drug development approach. Support MedImmune
publication strategy. Present and report data in approved external conferences
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
regulatory filings.
Skills:
* Demonstrated expertise in pharmacometrics and strong quantitative skills.
* Prior experience in regulatory filings is highly desirable for Sr
Pharmacometrician and required for Principal Pharmacometrician
* Proven track record of extensive experience in population modeling and
simulations using NONMEM.
* Familiarity with statistical software package Splus, R or SAS.
* Good communication and scientific writing skills, and ability to
independently work in a matrix environment.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual
Orientation
Req ID
11006
Interested candidates please apply online at
https://www.medimmune.com/about-us/careers.html# and use Requisition ID 11006.
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