Layer, Chiang, et al. Genome Biology
Aires Pharmaceuticals, Inc. a privately-held drug development and clinical stage pharmaceutical company located in San Diego is looking for a Senior Director, Clinical Operations. This is a key position, reporting to the Chief Medical Officer. The successful candidate will be part of the Clinical Development team which is responsible for conduct of clinical development of a Phase 2 inhaled drug to treat pulmonary hypertension.
Primary Duties and Responsibilities:
•In collaboration with the Chief Medical Officer, identify and evaluate internal and external resources required to efficiently run the clinical operations. Independently manage external partners for outsourced work.
•Recommend and implement processes governing trials management and timelines
•Manage project planning, budget and resource deployment for clinical studies.
•Oversee management of CROs, including RFP process and management of overall project timelines and deliverables
•Oversee management of clinical study sites. Travel to sites to supervise and coordinate clinical studies as needed.
•Participate as an integral member of the development team to provide clinical operational input in the overall product development planning. Ensure coordination with product development to ensure adequate clinical drug supply and tracking
•Manage and support clinical investigators for studies and ensure compliance with protocols and overall clinical objectives.
•Manage resources and timelines associated with all study start-up activities, including CRO/investigator agreements, IRBs and other contractual agreements.
•Ensure appropriate development of all documents by CROs including study documents, informed consent forms, case report forms and instructions, investigator update and other project-related documents.
•Collaborate with others in design and implementation of clinical protocols, clinical data collection and quality management
•Collaborate on (and author as necessary) and review of clinical documents (e.g., Investigators brochures, Annual IND Safety Reports, study reports, etc).
•Ensure compliance with GCP and all regulatory guidelines
•B.S, B.A. or BSN in health related field
•Minimum 10 years experience in all aspects of clinical trial management involving the establishment, planning, operation, and successful timely completion of projects.
•Thorough knowledge of US and EU GCP regulations.
•Strong experience with management of CROs.
•Excellent negotiation skills.
•Excellent problem solving skills and issues management.
•Excellent written and oral skills required.
•Strong sense of urgency and flexibility to work in a fast-paced organization.
•Excellent interpersonal skills.