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Associate Scientist I, Pharmacokinetics/Associate Scientist II, Pharmacokinetics

MedImmune, LLC

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Location: Hayward, CA Posted Date: 5/6/2013 Position Type: Job Code: 7289 Required Education: Bachelors Degree

Description

Title: Associate Scientist I/II, Pharmacokinetics
Location: CA, Hayward

The primary function of a PK Associate Scientist is to support Clinical Pharmacology & DMPK project leaders and team representatives through all stages of a candidate drug's development cycle. The PK Associate Scientist will be responsible for all aspects of PK-related support for biologics -data evaluation, data analysis, interpretation, reporting, and generation of manuscripts/abstracts for publication. Specifically- preparation of toxicokinetic reports, clinical PK sub-reports, pre-clinical and clinical protocols, slide preparations, abstracts and manuscript preparation; perform non-compartmental PK analysis, dataset preparation for NONMEM analysis, simple NONMEM analysis and reporting of data, and aid presentation of PK data in regulatory documents and meetings. He/she is expected to function with minimal supervision.

Major Duties and Responsibilities:
- Support PKPD project leaders by performing PK data evaluation, analysis, interpretation, and reporting of pre-clinical and clinical studies
- Collaborate with PK scientist and scientific writer to prepare and finalize PK, TK, Immunogenicity and Bioanalytical sub-reports
- Comply with GLP regulations for GLP studies toxicokinetic reports
- Assemble data sets for WinNonlin and NONMEM analysis
- Independently perform noncompartmental analysis
- Prepare PK/PD and bioanalytical subr-reports for outsourced studies; review and finalize study reports
- Support PK scientist in the preparation of PK, PK/PD components of internal documents, briefing books and regulatory submission documents (e.g. IND, NDA, IB and other regulatory documents)
- Collaborate with PK scientist and scientific writer to generate abstracts and manuscripts for publication

~BSP

Requirements

We can hire at either the Associate Scientist I or the Associate Scientist II level.

For an Associate Scientist I level, we require  a BS with 5 plus years of experience; for a MS, we require 2 plus years of experience.

For an Associate Scientist II level, we require a BS with 7 plus years of experience; for a MS, we require 4 plus years of experience.

Strong analytical and technical writing skills are required for this position. Good communication/organization skills and familiarity with WinNonlin are essential. Prior experience and knowledge of PK/PD modeling is desirable. Ability to evaluate and interpret standard pharmacokinetic and pharmacodynamic scenarios and prepare toxicokinetics/PK reports, Ability to work in a dynamic team oriented environment and work on multi-tasks.

Education:
Bachelor's or Master's degree in pharmaceutical sciences, biological sciences, chemistry or related field or a Doctor of Pharmacy. Other Doctorate level degrees will not be considered, only PharmD's.

MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.

MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune's approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune's approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.

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 wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals 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 encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.
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