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Job #03391

About our client Our client is a global biopharmaceutical company focused on the discovery, development and commercialization of therapeutic products for the treatment of patients with life-threatening diseases and incapacitating conditions. Position Location Medical Director Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Handle medical monitoring of clinical trials 2) Provide scientific and medical expertise for clinical trials as well as consulting projects 3) Act as a medical resource for staff members 4) Review and manage Serious Adverse Events (SAEs) during clinical trials 5) Participate in management of SAEs 6) Interact with the FDA and participate in advisory boards 7) Participate in developing and reviewing scientific writing projects 8) Develop and review study protocols and reports, manuscripts, FDA briefing documents as well as regulatory analyses 9) Create and conduct employee training 10) Attend capabilities presentations and make client visits (as needed) 11) Identify potential areas of business development and client expansion 12) Oversee the company's India operations and report on their progress to management Requirements 1) Master’s degree/Bachelor’s degree in a related discipline 2) Minimum 7 years of experience in the pharmaceutical/biotech industry or CRO experience 3) Experience in leading clinical and cross-functional teams 4) Knowledge of GCP and ICH guidelines 5) Proven ability to manage an overseas office 6) Willingness to travel primarily to Asian countries (up to 50%)