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Scientist I/II
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Scientist I/II : MedImmune, LLC.
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| Job Number |
02216 |
| Employee Type |
Full Time |
| Company Name |
MedImmune, LLC. |
| Location |
Gaithersburg
Maryland
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| Salary (year) |
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| Start Date |
2/9/2010 |
| Industry |
Biotech |
| Job Type |
Research-Translational-Science |
| Relocation |
Not Required |
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| Description |
Description
Title: Scientist I/II
Location: MD, Gaithersburg - Corporate Headquarters
Req: 02216
Position Summary:
Provide quantitative pharmacokinetic and pharmacodynamic modeling and simulation expertise to pre-clinical and clinical project teams. Apply quantitative PK /PD modeling and simulation to inform dose selection and dosing schedule for pre-clinical and clinical studies and provide design goals for drug candidates.
Major Duties and Responsibilities (including supervising others):
• Analyze, interpret and report pharmacokinetic and pharmacodynamic data from pre-clinical and clinical studies
• Analyze, interpret and prepare toxicokinetic study reports
• Perform population PK and PK/PD analysis and simulation
• Help Senior PK PD team members prepare data sets, posters, publications, PK and PD analysis for execution of project deliverables
• Prepare PK, PK/PD and population PK components of investigator¡¦s brochure, study protocols, study reports, project summaries and development plans
• Perform PK/PD analysis and simulations for prediction of pre-clinical and clinical PK and dosing
• Investigate relationship between PK and clinical effects, biomarkers and side-effects
• Able to work cross-functionally with other MedImmune departments including Research, clinical testing, Drug Safety, Biostatistics, Clinical Development and Regulatory Affairs groups.
• Provide PK support for formulation development
• Prepare and/or review PK, PK/PD components of internal documents, briefing books and regulatory submission documents (e.g. IND, NDA, IB and other regulatory documents)
• Prepare appropriate responses to Health Authority Inquiries on PK and PK/PD related issues
• Prepare and review scientific publications, posters and abstracts.
About the Organization
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.
Company Information
MedImmune, LLC. is an Equal Opportunity 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.
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| Requirements |
Position Requirements
Special Skills/Abilities:
„o Candidate should possess good understanding of pharmacokinetic and pharmacodynamic principles
„o Candidate should have hands-on experience in population PK/PD modeling and simulation using NONMEM
„o Candidate should have worked with WinNonlin or other PK and PK/PD software.
„o Interest in planning, designing, interpreting and reporting of preclinical and clinical pharmacokinetic and pharmacodynamic studies including population PK/PD modeling is essential
„o Strong analytical and critical thinking skills
„o Strong written and oral communication skills and interpersonal skills are essential
Job Complexity: Ability to evaluate, analyze and interpret standard and complex pharmacokinetic and pharmacodynamic data from pre-clinical and clinical studies in order to aid rational and informed decision making in drug development at MedImmune.
Supervision: Ability to work independently with minimal supervision. Should be able to multi-task and prioritize assignments. Able to work well with other interdisciplinary teams.
Educational Requirements
Requirements/Qualifications:
Education: Candidates with a Ph.D (or equivalent) degree in pharmacokinetics, biopharmaceutics or related field
Experience: At least 0-4 years of pharmacometrics experience in pharmaceutical industry or regulatory agency. Hands-on experience in modeling (preferably, with NONMEM) and programming skills (preferably, in S-Plus, R or SAS) are desired
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