Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		Job #07264 About our client Our client is a privately held biopharmaceutical company that is focused on development of a variety of drug therapeutics. The company has an experienced management team, a growing pipeline and an empowering culture that is focused on the long-term development of its employees. Position Location Director, Clinical Development WA Salary Highly competitive package, commensurate with experience Responsibilities Partial Job Description 1) Foster robust clinical development programs by utilizing various resources and providing appropriate guidance to teams 2) Oversee clinical development across all projects 3) Establish and maintain SOPs and/or other documents for all areas to support clinical development work 4) Establish and maintain electronic records system for the storage of records needed for regulatory registrations 5) Establish and maintain budgets, timelines, projections and site payments systems 6) Ensure training programs are in place and document GCP compliance for all staff and contractors 7) Establish and maintain high quality clinical document templates (contracts, informed consents, protocols, investigator brochures) 8) Prepare the clinical development sections of compound development plans and ensure that plans are in place for all aspects of the clinical studies (data management plan, monitoring plan, safety plan etc.) 9) Establish and maintain tracking systems for all clinical development functions 10) Manage day-to-day operations of the department across all compounds for clinical operations, biometrics and safety reporting 11) Develop, manage and communicate budget and timelines 12) Mentor staff and develop the department's infrastructure 13) Establish an overall quality plan for the monitoring and management of trials 14) Ensure strict compliance with ICH/GCP and SOPs at all levels during the trials 15) Manage all staff (permanent and contract) as well as all vendors Requirements Qualifications / Skills Required 1) Bachelor's degree (Advanced degree preferred) 2) Minimum 10 years of industry experience, including 6 years of international pharmaceutical clinical development experience in a biotechnology or small pharmaceutical company 3) Experience in Phase 1 - 3 trials 4) Experience directly managing CRAs 5) Background in CRO/project/contract management 6) Knowledge of data management, safety reporting processes and international standards 7) Prior experience working in a start-up environment is highly preferred 8) Oncology clinical trial experience 9) NDA filing experience preferred
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