WHAT YOU’LL DO

• Accountable for successfully executing clinical studies and programs to meet pertinent timelines and clinical milestones.  
• Develops the clinical operations strategy to include risk management and contingency planning
• Demonstrate a high level of expertise with operational processes and requirements, effectively applying this knowledge to lead the clinical operations function to achieve corporate objectives
• Understand the patient journey in clinical trials and potential patient safety and logistic issues to optimize the team’s recruitment strategies
• Establish, monitor and report on performance standards and metrics for the execution of clinical projects with a focus on the proactive identification of issues and implementation of appropriate corrective actions
• Identify and implement innovative solutions to resolve roadblocks in patient recruitment and clinical trial execution
• Build relationships with investigators/site personnel and CROs/other contractors to drive effective communication and collaboration for the most successful clinical trials 
• Own clinical operations budget and provides forecasts and monitoring of budgets across all clinical programs for near-term and long-range planning by developing accurate assumptions and prudent allocation of resources
• Identify, evaluate, select, manage, and provide oversight of CROs/other contractors; this role is the primary point of contact for escalation of issues, including development of risk mitigation strategies
• Utilize a robust and creative approach to maximize the value of CRO activities with a rigorous approach to budgetary control
• Implement best practices and standards for trial management in collaboration with other members of the clinical team, including the establishment of SOPs
• Collaborate with Quality Assurance, Regulatory, and Clinical to ensure that clinical trials meet compliance, regulatory, and patient safety requirements
• Establish and maintain strong partnerships with CRO’s, partners, vendors, and external stakeholders.
• Provide oversight, mentorship and career development opportunities to direct reports.
• Represent the company as a senior clinical operations spokesperson before appropriate scientific, medical, regulatory, business associates and others in professional meetings.

WHO YOU ARE

• BS or equivalent;  advanced degree preferred.
• 15+ years of experience in building and managing complex clinical operations teams- a fast-paced, high-growth biotech companies
• Proven track record of managing complex cell therapy, autologous cell therapy, and early to late phase studies, preferred.
• Proven track record of managing programs across all phases of clinical development, including successful FDA inspections and audits
• Experience conducting complex clinical programs across multiple geographies
• Knowledge of advanced information technology systems to facilitate complex clinical monitoring and sample tracking.
• In-depth knowledge of GCP guidelines, FDA regulations and clinical operations development processes.
• Excellent organizational skills and ability to prioritize and deliver results.
• Excellent communication and influencing skills and proven ability to lead in a matrix environment.
• Creative and innovative leadership with a sharp objective intellect and experience balancing big-picture thinking with detailed analysis.