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Job #02778

About our client Our client is a rapidly growing biotech company headquartered in Massachusetts that is focused on the development and commercialization of various infectious diseases therapeutics. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Clinical Pharmacologist Cambridge, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead scientific and strategic planning 2) Oversee internal and external project communications 3) Design clinical pharmacology components (pharmacokinetic and pharmacodynamic) of clinical trials in all phases of development 4) Prepare clinical documentation regarding NDA-directed clinical development programs for drug candidates with an emphasis on clinical pharmacology studies 5) Design Phase I studies and clinical pharmacology components in Phase II – IV trials 6) Analyze data, interpret results and first-author clinical pharmacology-related clinical documentation (clinical protocols, study reports, abstracts and manuscripts, presentations, other IND and NDA documents, etc.) 7) Handle various internal and external documents and communications (as needed) 8) Work with Clinical Operations to help develop the operational strategies for clinical pharmacology studies and development programs, investigator selection, CRO selection, budgets, etc. 9) Help manage program timelines for clinical pharmacology components and related matters 10) Manage budgets to meet or exceed time, quality and fiscal objectives Requirements 1) Pharm. D. or Ph. D. in Clinical Pharmacology, Pharmacokinetics, Biopharmaceutics or a related field 2) Minimum 2 years of industry experience 3) In-depth knowledge of pharmacokinetics and pharmacodynamics as well as their integration in the clinical drug development process 4) Familiarity with regulatory issues related to Phase I – IV clinical research 5) Experience in technical writing (documented first authorship of protocols, study reports, regulatory communications, manuscripts, etc.) as well as IND and NDA submission preferred 6) Expertise in using industry-standard PK and PK/PD software for non-compartmental, modeling and population-PK and PK/PD analyses and simulation 7) Expertise in the design, analysis and reporting of clinical pharmacology studies