Pharmacometric Scientist/Sr. Scientist (6+ month contract engagement): Career Developers
| Job ID | TY101616 |
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| Company Name | Career Developers |
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| Job Category | Pharmaceutical/Biotech |
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| Location | Fort Lee, NJ |
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| Position Type | Full-Time, Contract |
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| Experience | 2-5 Years Experience |
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| Date Posted | October 29, 2009 (Reposted Nov 12) |
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| View Career Developers profile and job listings |
Pharmacometric Scientist/Sr. Scientist (6+ month contract engagement)
Employment agency specializing in Information Technology,
Life Sciences
and Finance recruiting, permanent and consulting
services.
Pharmacometric Scientist/Sr. Scientist (6+ month contract engagement)
Location: Fort Lee N.J
Required Education: Ph.D.
Areas of expertise desired: Pharmacometric PK/PD modeling and simulation hands-on experiences and techniques, population study design in late phase studies.
Job Responsibilities:
Lead the design and implementation of pharmacometric PK/PD elements in clinical studies consistent with the Clinical Pharmacology plan to ensure studies are scientifically sound, medically appropriate according to GCP/ICH guidelines. Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of intricate PK and PD modeling and simulation initiatives, including population PK and PK/PD analyses using early to late stage clinical study data. These studies may include firstin-man, multiple ascending, food effect, mass balance, drug-drug interaction, special population, bioequivalence studies and late phase studies in patients with population PK component. Represent Clinical Pharmacology on interdisciplinary project teams, including clinical teams and subteams as appropriate. Effectively communicate the pharmacometric elements of Clinical Pharmacology plans to management and regulatory authorities as appropriate. Ensure Clinical Pharmacology initiatives are supported through publication strategies via manuscript publications and presentations at global meetings. Advocate Clinical Pharmacology initiatives at clinical investigator meetings, advisory meetings and various scientific forums as appropriate. Provide mentoring and leadership for modeling and simulation activities to Clinical Pharmacology department and study team members as appropriate. Ensure knowledge of regulatory guidance, Good Clinical Practice and SOPs related to pharmacometric elements of clinical studies. Prepare and compile pharmacometric elements of clinical pharmacology regulatory submissions and documents.
Lead preparation and execution of pharmacometric aspect of Clinical Pharmacology plans and strategy to meet corporate, scientific and regulatory needs.
Requirements:
The candidate must possess a PhD in pharmacokinetics or a closely related discipline or Pharm D or MD with at least 3 plus years of knowledge and experience in sophisticated hands-on population PK/PD modeling and simulation to apply to drug development within the pharmaceutical industry. Candidates with MS and 7 plus years of knowledge and experience in hands-on population PK/PD modeling and simulation within the pharmaceutical industry could be considered. The applicant should have experience and training with a range of skills including pharmacokinetic analysis, population approaches in constructing population PK/PD models, performing simulations, and making predictions. The applicant should have experience with software in population PK/PD analysis and modeling such as NONMEM, SPLUS and/or SAS etc. In addition, the candidate should have experience in preparing population PK/PD sections of various regulatory documents. The incumbent should have experience within a team environment, strong presentation skills, organizational skills, interpersonal skills, communication skills, and demonstrate self-motivation.
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