AD of Clinical Operations - 1400871SKI_3-4658
About the position Responsibilities • Oversight of clinical operations activities including project management, site management, and clinical systems management. • Support government or commercial contracts in multiple therapeutic areas such as infectious disease, oncology, and medical devices. • Manage project oversight for multiple functional areas within complex drug development programs. • Communicate effectively in a matrix management organization and represent the clinical team during cross-functional collaboration. • Provide operational expertise to support program/project level functional areas. • Collaborate with the Director and other departments on clinical operations strategy and vision. • Inform division leadership on the status of clinical programs/projects and potential issues. • Ensure documentation of processes and workflows are followed and determine actions to prevent delays. • Support the company's Quality Management System policies and drive performance improvement solutions. • Contribute to corporate initiatives such as process improvement and SOP development. • Manage line responsibilities and staff hiring activities within the clinical operations department. • Participate in proposal writing, budget development, and bid defense meetings. • Support inspection readiness and assist in audit preparation and follow-up activities. • Establish Risk-Based Quality Management and Centralized Monitoring processes for clinical trials. • Review protocols to ensure compliance with reporting requirements for KRIs and QTLs. • Provide technical oversight and coordination for central monitoring activities. Requirements • AD level leadership experience with the ability to establish centralized monitoring structures. • Broad multidisciplinary understanding of pharmaceutical clinical research and development processes. • Hands-on regulatory, clinical operations, or clinical trial monitoring/management experience. • Ability to mentor staff and achieve high-quality performance through risk management and corrective actions. • Strong facilitation, presentation, problem-solving, and conflict resolution skills. • Excellent oral and written communication skills with strong attention to detail. • Expertise in Microsoft Word, PowerPoint, and Excel; experience with Microsoft Project is required. • 10 years minimum experience in the pharmaceutical or biotechnology industry. Nice-to-haves • Proposal writing and bid defense skills. • Background in Infectious Disease/HIV clinical trials or Oncology. • Experience in conducting Phase 1 protocols or working on government contracts. Benefits • Remote work flexibility with onsite requirements for client meetings once a month. • Travel expenses covered by the company. Apply tot his job