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Job #02936

About our client Our client is the biotech division of a global publicly traded pharmaceutical company with over 100,000 employees. They are at the forefront in the development and commercialization of therapeutics in multiple indications, and are well known for high-quality standards and commitment to innovation. 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 Head of US Clinical Development Boston, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Plan, direct, implement and manage the US strategy and clinical development for the company 2) Contribute to planning of clinical trial programs for investigational drugs, based on overseeing pre-clinical, regulatory, manufacturing and quality assurance issues 3) Guide drug candidates from lead phase to registration 4) Plan, prepare, coordinate and implement US studies as well as phases II, III and IV in the clinical area (in the context of clinical development) 5) Oversee all activities of clinical project managers and CRAs 6) Develop clinical protocols as per study outlines 7) Consolidate design aspects with regard to feasibility 8) Analyze key success factors regarding study design feasibility 9) Ensure medical-scientific basis and coherence with the company’s Master Plan and SOPs 10) Participate in study site selection and Investigator meetings 11) Develop and contribute to negotiations 12) Implement contracts with study site clinics, CROs and other clinical support vendors 13) Train all study participants in medical aspects of studies 14) Oversee US medical monitoring of study teams 15) Support regulatory submissions 16) Ensure efficient and timely communication as well as support to the parent company 17) Manage information flow 18) Perform other duties as assigned Requirements 1) US Medical degree (MD) 2) Minimum 3 years of experience in pharmaceutical clinical drug development and investigations 3) Experience in a supervisory role 4) Experience in the field of medicine and life sciences 5) Experience in communicating with clinical heads, residents, study nurses and medical administrators 6) Knowledge of transplantation/immunology (relevant to drugs and biologics) 7) Working knowledge of medical terminology and statistical concepts 8) Excellent editorial/proof-reading skills 9) Superb communication skills (verbal and written) 10) Good IT skills 11) Ability to summarize raw data in a concise, accurate and easily understandable form 12) Ability to take initiatives 13) Thorough, detail-oriented and methodical individual