- 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)
Job Region: Boston
Provides disease area expertise and opportunities for Clinical Pharmacology contributions to Core Team Oversees interpretation of complex data, provides leadership to Core Team in model based drug development, introduces “state-of-art” translation medicine strategies, platforms and methodologies to Core Team Defines and maintains a leading overall exploratory development and clinical pharmacology strategy that will ensure the… Continue Reading
With guidance, perform non-compartmental pharmacokinetic (PK) data analysis and reporting for regulatory submission using WinNonlin. Under direction, provide inputs to designing clinical pharmacology studies, protocol development, and provide support to study execution. Assist in the planning, implementing, interpreting and reporting of assigned Phase I to III studies. Under direction, devise PK and PK-PD analysis plan… Continue Reading
Sr. Scientist/Associate Director Requirements: A Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Biomedical Engineering or related discipline. Level commensurate with experience Relevant PKPD experience and demonstrated impact on drug development and/or the PKPD scientific landscape. Preferred qualifications: Strong knowledge and experience in either oncology, immunology, and/or tumor immunology are highly desired. Strong knowledge and experience in… Continue Reading
AD/Director Clinical Pharmacology and M&S Essential Functions: The Director of Clinical Pharmacology is accountable for planning and integrating clinical pharmacology studies, which meet standards of excellence, ethical, regulatory, and legal requirements, into overall clinical development program objectives. The Director ensures that clinical pharmacology studies meet agreed timelines and budget and deliver pivotal, decision-making knowledge for… Continue Reading
Carter Mackay is based in Crown Colony Office Park, Quincy and is recognized as one of the industry leaders in the field of executive search and placement.. For the past 40+ years the company has continued to expand and grow into the premier recruiting firm nationally, specializing in placing in the technology, healthcare, scientific and… Continue Reading
Position Description: Exciting new opportunities for MEDICAL SALES in the Boston area. This highly acclaimed Medical Company is totally committed to its employees and provides the support necessary to make you better than the best. NOW is the time to get in on the ground floor and climb the ladder all the way to the.… Continue Reading
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