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Principal Scientist/Associate Director
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Principal Scientist/Associate Director : MedImmune, LLC.
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| Job Number |
02138 |
| 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: Principal Scientist/Associate Director
Location: MD, Gaithersburg - Corporate Headquarters
Req: 02138
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. Collaborate, mentor and guide other PK-PD team members with pharmacometric support on their projects. Be a champion and advocate for pharmacometrics within MedImmune.
Major Duties and Responsibilities (including supervising others):
• Actively advocate and champion pharmacometrics across Medimmune
• Able to build, lead and establish a core modeling group with pharmacometrics expertise supporting projects at MedImmune
• Plan, design, analyze, interpret and report pharmacokinetic and pharmacodynamic data from pre -clinical and clinical studies
• Perform population PK, PK/PD modeling, analysis and interpretation of pre-clinical and clinical data
• Perform population PK, PD and PK/PD simulations for pre-clinical and clinical studies
• Prepare PK, PK/PD and population PK components of investigator¡¦s brochure, study protocols, study
reports, project summaries and development plans
• Perform PK/PD simulations and predict pre -clinical and clinical PK as appropriate
• Perform PK-clinical endpoint/outcomes modeling and simulation to support dose selection and overall clinical study design
• Investigate relationship between PK and clinical effects, biomarkers and side -effects
• Provide expert advice on issues relating to PK, PD, patient population, and dose/regimen selection to project teams
• Interpret and present project related study results and recommendations to management and relevant project and therapy teams
• Collaborate, mentor and guide other PK-PD team members with pharmacometric support on their projects.
• Interact cross-functionally with MedImmune departments including Medical Organization, Research, Translational Science, Clinical Testing Laboratory, 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 regulatory health authority inquiries on PK and PK/PD related issues
• Provide PK, PK/PD and pharmacometrics expertise in regulatory and other advisory meetings
• Actively prepare, review and publish scientific publications and abstracts
• Pharmacokinetic & Pharmacodynamic department representative on project teams
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: Candidate should possess good understanding of pharmacokinetic and pharmacodynamic principles
„o Candidate should have extensive experience in quantitative population PK/PD modeling and simulation using NONMEM and S-plus
„o Candidate should have extensive experience in clinical endpoint modeling, disease progression modeling and mechanistic modeling
„oƒnCandidate should have experience writing pharmacometric reports to support regulatory filings
„o Candidate should have worked with WinNonlin and other commonly used PK and PK/PD software.
„o Experience in planning, designing, interpreting and reporting of clinical pharmacokinetic and pharmacodynamic studies including population PK/PD modeling is essential
„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. Provide mentoring and pharmacometrics support to other PK-PD team members. Promote role of pharmacometrics across MedImmune and represent Pharmacokinetics and Pharmacodynamics effectively on project teams.
Educational Requirements
Requirements/Qualifications:
Education: Candidates with a Ph.D (or equivalent) degree in pharmacokinetics, biopharmaceutics or related field
Experience: At least 5 years of pharmacometrics experience in pharmaceutical industry or regulatory agency. Should have hands -on experience and be an expert in NONMEM, S-plus, SAS and WinNonlin and be familiar with drug development process.
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.
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