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Job #02558

About our client Our client is an early stage biopharmaceutical company headquartered in Boston that is dedicated to the development and commercialization of therapeutics for "late onset" diseases such as osteoporosis. 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. This is a great opportunity for the right candidate! Position Location Clinical Program Director Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Participate in product development programs 2) Perform a key role in the designing, implementation and management of clinical programs and studies 3) Play a leadership role in attaining the successful completion of clinical projects in the US. and Asia, including clinical association studies and prospective clinical trials 4) Manage clinical programs and studies and ensure appropriate intersection of clinical strategy with product development activities 5) Lead product development programs 6) Integrate pre-clinical activities in the product development programs 7) Manage recruitment/selection of new investigators, contract research organizations (CROs) and outside vendors 8) Collaborate with investigators to design optimal recruitment strategies for single and multi-center trials 9) Develop protocols and associated clinical study documents compliant with ethical human subject regulations/requirement, GCP standards, etc. Requirements 1) BS or a higher degree in Health Care or Science 2) 5+ years of experience in a clinical research setting within a pharmaceutical/biotechnology company 3) Experience in clinical project/program management 4) Experience in handling multiple projects – some of which are with international components 5) Proven record of managing project budgets and timelines 6) In-depth knowledge of SOPs, FDA, ICH and GCP guidelines 7) Experience in protocol design, investigator recruitment, clinical study/trial coordination and site management 8) Excellent oral and written communication skills 9) Strong analytical, problem-solving and negotiation skills