• Integrates drug metabolism, pharmacometrics, and toxicology data to assist in the development of the clinical pharmacology aspects of oncology and/or ophthalmology compounds.
• Works with the Clinical Pharmacology Heads and their Therapeutic Area to advance multiple compounds by integrating PK/PD and clinical data to evaluate/simulate optimal doses/regimens, exposure-response, exposure-safety analyses, etc. to support the clinical pharmacology section of product inserts.
• Designs and writes clinical PK protocol synopses, PK analysis plans, study reports, and Clinical Pharmacology sections of regulatory submissions. Works independently to analyze, interpret and apply new clinical data to refine the PK development plan is essential.
• Assesses results from standard PK software (e.g., WinNonlin, NONMEM) while proficiency in the use of such programs in not required. Actively participates in cross-functional and clinical teams by promoting clinical pharmacology, explaining/defending the PK strategy and data analyses and providing PK deliverables according to timelines.
Requirement:
Prior laboratory experience; good communication skills; good understanding of cellular biology; curiosity and able to see the bigger picture
Additional Skills: Looking for entry level to intermediate...
Best Regards,
Anuj Mehta
973-967-3402
Job details are sourced from the employer's original posting.
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Artech is an employer-of-choice for the last 25 years to over 7,500 consultants across the globe. We recruit top-notch talent for over 70 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are #1 Largest Women-Owned IT Staffing Firm in the US and this may be your opportunity to join us! For more check: www.artechinfo.com