cartermackay Associate Director, Clinical PK—MA
- Support preclinical and clinical development programs with expert input to study design, evaluations, integrated data analysis and reporting based on clinical pharmacology strategy.
•Perform or oversee PK/PD modeling and exposure-response analysis using a variety of tools and approaches. Integrate, interpret, and report data to project teams and business partners.
•Lead or participate in Clinical Pharmacology or Program sub-teams. Coordinate with appropriate sub-team members and/or prepare summary documentation.
•Contribute expert input into key preclinical and clinical, and regulatory documents including study protocols and reports, PK/PD modeling reports, investigator brochures, IND/IMPD’s and NDA’s within agreed timelines.
•Attends meetings with external parties including investigators, outside experts, and health authorities.
•Monitor timelines, objectives, and budgets. Ensure rapid and effective communication of high-quality data and results to project teams.
•Work with bioanalytical and modeling and simulation CROs.REQUIREMENTS:
•Ph.D. in pharmacokinetics, pharmaceutical sciences or a related discipline, Pharm D. with appropriate post-doctoral training, or equivalent experience
•At least 6 years of experience in pharmaceutical or biotech industry
•Expert knowledge of pharmacokinetics/pharmacometrics tools (e.g., Phoenix WinNonlin/NLME, NONMEM, R, S-Plus, SAS, Trial Simulator)
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