Director, Clinical Operations

• Provide clinical study operations leadership for large-scale, fast enrolling, and biospecimen centered clinical trials for IVD development.
• Manage operational plans and timelines to achieve on-time enrollment and study completion.
• CRO management, site operations/monitoring, and data delivery milestones in line with corporate goals.
• Identify barriers to timely and successful study execution and propose solutions, with regular reporting of program performance metrics.
• Manage a small but growing Clinical Operations team, ensuring development, engagement, and training opportunities.
• Lead initiatives to improve systems, processes, procedures to drive quality into Clinical operations, including GCP training programs, SOP gap-assessments/overhaul projects, and rigorous internal audit plans.
  Develop communication strategies to work cross-functionally effectively in project team situations to influence, collaborate, and meet the needs of internal and external stakeholders.
• Collaborate with senior management to develop project timelines, study budgets, and report periodically on project status to all stakeholders.
• Oversee and manage all operational aspects at the Clinical Program level, including investigator selection, analysis, and KOL collaborator engagement.
• Prepare study-related documentation, including protocols, case report forms, consent documents, clinical trial agreements, project management plans, etc.
• Collaborate with internal cross-functional teams on assay development activities
• Ensure compliance with all regulatory requirements by monitoring compliance with all company standard operating procedures (SOPs), GCP, FDA, and applicable international regulations concerning clinical activities.

‍

• Undergraduate degree, advanced degree /or additional coursework in clinical trial planning and execution preferred.
• Minimum of 10 years of clinical trial management experience in the pharmaceutical, biotech, or diagnostic industry, preferably in vitro diagnostics (IVD).
• Clinical experience with large scale oncology trials.
• Experience in building and managing a high performing Clinical Team.
• Data management experience and knowledge of statistical principles as applied to clinical trials.
• Strong track record of management of clinical study operations staff and team leadership.
• Thorough knowledge of GCP, ICH guidelines, and US and international clinical regulatory requirements.
• Ability to develop positive working relationships with individuals and teams internally and externally.
• Ability to work independently as well as part of a cross-functional team.
• Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills.
• Ability to travel as required (~25%).