Medical Director, Psychiatry

Posted 4 months agoViewed
United StatesFull-TimePharmaceutical
Company:Rho Inc
Location:United States
Languages:English
Seniority level:Director, 5+ years
Experience:5+ years
Skills:
LeadershipProject ManagementBusiness DevelopmentCross-functional Team LeadershipStrategyCommunication SkillsAnalytical SkillsProblem SolvingMentoringComplianceStakeholder managementResearchRisk Management
Requirements:
Medical degree from a fully accredited medical school Holding (or having held) an active medical license in good standing Board certification in Psychiatry 5+ years of experience in clinical medicine beyond residency 5+ years of clinical development experience (ideally in the pharmaceutical or a closely related industry) Good understanding of research methodologies and clinical trial design, including biostatistics Good understanding of scientific and ethical regulations and guidelines pertaining to clinical research, including knowledge of federal drug development regulations and guidelines Ability to establish and meet multiple concurrent priorities, deadlines, strategic department goals and objectives Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility Ability to establish and maintain cooperative and effective working relationships with coworkers, managers, and clients Excellent communication and interpersonal skills, ideally with experience/expertise in public speaking and engaging external stakeholders
Responsibilities:
Serve as Medical Advisor on assigned projects. Provide medical support to investigative sites and project staff. Perform review and clarification of trial-related Adverse Events (AEs) and coding. Perform medical case review of Serious Adverse Events (SAEs). Perform medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs). Perform medical review of the Clinical Study Report (CSR), patient narratives, and other high-profile documents. Serve as Scientific Advisor and provides guidance to Project Managers. Participate in the development of Medical Monitoring portion of client proposals. Support Business Development activities by reviewing and providing medical/scientific input. Support Feasibility activities as required.
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