Head of Clinical OperationsKaloBios Pharmaceuticals
Reports to: Chief Medical Officer
The Head of Clinical Operations will report to the Chief Medical Officer and will oversee the clinical operations function at KaloBios.
Oversee the Clinical Operations functions and all activities related to execution of clinical studies and programs in accordance with company SOPs, FDA, & ICH guidelines and regulations
Direct the successful execution of all clinical trials, programs, timelines and clinical milestones
Demonstrate a high level of expertise with clinical and regulatory requirements regarding clinical operational processes and requirements, and effectively apply this knowledge to lead the clinical operations department to achieve corporate objectives
Direct the successful technical execution of clinical programs and protocols
Provide direction for all internal and external staff and resources associated within clinical operations, CRO's and vendors
Program team leader for interdisciplinary project teams to ensure the successful execution of clinical programs and clinical operations
Working closely with the CMO and VP of Regulatory to develop strategy necessary for successful data collection, assessment, analysis, and data management with the CRO
Resolve clinical operations issues, such as data management, monitoring, timelines, drug distribution, safety assessment, regulatory compliance, etc.
Manage all budgets, contracts, agreements, vendor payments and processes to conduct clinical trial programs in an effective manner
Oversee data collection activities for all clinical programs: CRF, SAE assessment, queries, and follow-up, annual reports, investigator brochures, NDA, etc.
Oversee management, professional development, training and performance of all clinical operations staff
MS, PhD or equivalent, and 10+ years of increasing responsibility in a clinical operations group in a CRO and the biotech/pharmaceutical industry, and strong background in successful execution of large global clinical programs
Proven history in drug development illustrated through clinical trial and regulatory accomplishments (NDAs/INDs)
Experience in several therapeutic areas, including pulmonary and oncology
Experience in CRO operations management
Outstanding communication and presentation skills are required. Must be able to establish peer relationships and communicate effectively with multiple company disciplines, cross-functional, and external teams
Excellent project management, organizational and negotiation skills are required
Ability to implement the Clinical Operations function and create consistent and accurate SOPs for all clinical programs is required
Computer proficiency in Word, Excel, Outlook and Powerpoint
Outstanding management skills and interpersonal skills, and the ability to work with all levels within the organization in a collaborative manner