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Job #02540

About our client Our client is a biopharmaceutical company dedicated to discovering and developing drugs for central nervous system (CNS) disorders. More hospitalizations, long term care and chronic sufferings are caused by CNS disorders than nearly all other diseases combined. There is a strong demand for improved medical treatment of these disorders as the current treatment options are not satisfactory. Position Location Director, Program Management – CMC Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Identify and manage CROs for all aspects of the drug product, drug substance, analytical chemistry, pharmaceutical sciences/formulation 2) Oversee all aspects of regulatory documentation needed for the European and US pre-clinical and clinical studies 3) Provide scientific and technical leadership for all aspects of drug substance through drug product for small molecule CNS drug development from pre-clinical through Phase-II clinical studies 4) Help in the development of CNS drug from pre-clinical through Phase-II clinical studies Requirements 1) Ph. D, Pharm. D or M.S. 2) Minimum 5 years of experience of managing all aspects of drug product and drug substance (including regulatory/CMC requirements to support all drug development programs through the regulatory processes from pre-clinical to Phase-II clinical studies) 3) Knowledge of the chemistry of small molecules would be a plus 4) Experience in regulatory/CMC 5) Strong knowledge of chemical development, analytical chemistry and/or pharmaceutical sciences experience a plus 6) Experience of working with CROs a plus 7) Experience in negotiating contracts, managing projects in multiple sites, interfacing different teams of outside contractors and organizing complex projects with detailed project plans and budgets a plus 8) Experience in pharmaceutical, biopharmaceutical companies or a full service CRO 9) Knowledge of the drug development process preferred 10) Ability to work in a fast paced biopharmaceutical environment 11) Experience of close association with products entering clinic a plus 12) Willingness to travel 13) Willingness to relocate to New England