My client is a rapidly growing biotech company with an exciting pipeline of small and large molecules within oncology and is looking for quantitatively oriented clinical pharmacologists.
Manager-Associate Director, Clinical Pharmacology The Manager-Associate Director, Clinical Pharmacology (CP) functions as the Clinical Pharmacology (CP) team representative at the Product Strategy Team for small molecule and biotherapeutics in Phase 1-3 of clinical development and is responsible for all aspects of clinical pharmacology-related support for candidates. This includes design and execution of clinical pharmacology studies, design of clinical pharmacology portion of other clinical studies, analysis and reporting of data, communication of results and strategy to project teams, and communication of data and analysis reports in regulatory documents and meetings. This position will report into one of the Senior Directors within the department of Clinical Pharmacology and Pharmacometrics. Title commensurate with the number of years of relevant experience. Essential Functions: * In collaboration with CP leadership, develop CP strategy and short/long-term plans for projects at all stages of clinical development - IND to NDA/BLA. Communicate these strategies at internal and external meetings * In collaboration with CP leadership, design, conduct, analyze, interpret, and communicate results from CP studies with guidance * Perform hands-on analyses of data using noncompartmental methods and population PKPD modeling and simulation methodologies and disseminate the relevant risk/benefit implications to project development teams. * In collaboration with CP leadership, develop and execute the regulatory strategy (e.g end of phase 1/2 meetings, Type C meetings, and NDA/BLA discussions) * Collaborate with Biostatistics, Clinical Research, Clinical Operation, and Drug Metabolism colleagues for the appropriate design of Phase I-III studies * Contribute to the preparation of key documents including investigators brochures, clinical study protocols, study reports, and regulatory briefing documents. * As a lean but growing department, contribute to the establishment of best practices for CP activities - e.g. draft department SOPs, establish quality systems, create plan/report templates, etc. Education & Experience: * An advanced degree in Pharmaceutics/Pharmacy/Engineering/Statistics with demonstrated expertise in quantitative PKPD skills. * Basic understanding of drug development. * Expertise with standard modelling and simulation software (NONMEM, S-Plus/R, etc) is required. Expertise in other modelling software (e.g. GastroPlus, SimCYP, MATLAB, Berkeley-Madonna, etc.) is highly desirable. * Experience of active and effective communication with cross-functional project teams. * Good oral and written communication skills as shown by a publication track record Other Information * Position level and title will be commensurate with experience * Position may require occasional evening and/or weekend commitment * Position may require occasional travel (~15%), domestic and international. ________________________________ K. David Cadieu KDC GROUP, INC. 239-564-4554 kdc...@placementgrp.com<mailto:kdc...@placementgrp.com>
