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Clinical Pharmacometrician
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Clinical Pharmacometrician : GlaxoSmithKline
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| Job Number |
60608 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
Research Triangle Park
North-Carolina
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
6/14/2010 |
| Industry |
Pharmaceutical |
| Job Type |
Clinical |
| Required Degree |
PharmD |
| Relocation |
Required |
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| Description |
Basic Qualification
Ph.D., Pharm.D., or M.D. Established track record in effectively applying clinical pharmacology principles and pharmacometric methodologies in order to aid rational and informed decision making in drug development.
Details
Because of the commitment of GSK to model-based approaches to enhance the quality and efficiency of drug development, we are seeking individuals to join our Clinical Pharmacology Modeling and Simulation Department. You will be responsible for influencing the strategy and contents of clinical development plans. Mathematical and statistical modeling and simulation will be your primary tools to timely design, analyze and interpret clinical trials. You will have the opportunity to explore, learn and utilize state-of-the-art methodologies to help shape our question-based product development plans and aid in dose selection. You will be advising colleagues on modeling and simulation methodologies. You will be working across the GSK drug discovery pipeline from pre-candidate selection through post-licensing within therapeutically-aligned groups.
• Provide modeling and simulation strategy and clinical development plan.
• Plan, design, analyze, and interpret PK and PK/PD data from clinical studies.
• Provide expert advice on dose/regimen selection and issues relating to clinical pharmacology (PK, PK/PD, ADME, DDI, special populations
(i.e., pediatrics, hepatic and renal impairment, elderly, etc.)).
• Investigate relationships between PK and clinical endpoints, biomarkers and adverse effects;
perform simulations to predict clinical response and study outcomes.
• Perform population PK and PK/PD analyses, provide interpretation and simulations.
• Interpret and present results and recommendations to management and relevant teams/committees.
• Prepare and/or review PK, PK/PD and clinical pharmacology components of study protocols, study reports, investigator’s brochure, development plans, project summaries/internal documents, and regulatory briefing and submission documents.
• Prepare appropriate responses to regulatory agencies on PK, PK/PD and clinical pharmacology related issues, including regulatory advisory meetings.
• Interact cross-functionally with company departments and groups.
• Prepare, review, publish and present scientific publications and abstracts. |
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| Requirements |
Preferred Qualification
At least 5 years of pharmaceutical industry experience. Experience in oncology, biopharmaceuticals, or viral diseases is preferred. Understanding of pharmacokinetic (PK) and pharmacodynamic (PD) principles, have extensive experience in population PK/PD modeling and simulation using NONMEM, S-PLUS, and/or other relevant tools, have worked with WinNonlin and other commonly used PK and PK/PD software. Experience in planning, designing, interpreting and reporting of clinical PK and PK/PD studies, creating clinical pharmacology development plans, and writing the relevant components of regulatory documents is essential.
An analytical and inquisitive mind for problem solving and strong written and oral communication skills are essential. Ability to work well and form effective relationships with interdisciplinary teams are necessary for collaborative work in our matrix environment. Ability to effectively represent Clinical Pharmacology Modeling and Simulation on internal teams and to external groups. Ability to work independently and prioritize assignments with minimal supervision. |
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