The Director, Clinical Affairs is responsible for leading and managing the strategy, planning, and execution of clinical research and investigational affairs while assuring full compliance with applicable GCP regulations as well as relevant worldwide standards and regulations. Provides global leadership for Clinical Research Activities. Responsible to interface with data management, biostatistics, regulatory agents, clinical research associates, study coordinators, field clinical specialists, business stakeholders, medical/safety monitors, and functional management. Acts as the liaison with key opinion leaders, site investigators, and clinical site staff. Responsible for clinical study designs and required documentation and all data publications including scientific publications with site investigators, white paper publications, clinical data summaries, etc.
This role requires strong technical and client management skills, the ability to work with cross-functional teams: Sales, Sales Operations, Engineering, Product Management, Regulatory Affairs, and Marketing.
We are looking for a highly motivated, self-directed individual who will thrive in a fast start-up environment and possess strong interpersonal skills.
Required Education and Experience:
Preferred Education and Experience:
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