Head of Clinical Operations

Biolojic Design is seeking a Head of Clinical Operations. This is a remote position based out of our state-
of-the-art facility on Children’s National Hospital’s Research and Innovation Campus in Washington, DC.

Candidates should be located on the East Coast of the United States.

Base salary range for this position is $220,000 to $280,000 annually, plus bonus potential.

The Head of Clinical Operations is responsible for leading and supervising all activities related to clinical operations, including the management and execution of clinical trials in accordance with Good Clinical Practices (GCP) as well as in compliance with various governing regulatory agencies. This role involves overseeing participating study sites, managing vendors, ensuring compliance with regulatory guidelines, and implementing innovative processes to improve clinical trial management and deliverables.

Actual job title will be based on education and experience. This position reports to the Chief Medical Officer.

• Manage and oversee the Clinical Operations execution of First-in-Human studies and associated activities in compliance with GCP and regulatory requirements.
• Supervise site selection process, identifying and evaluating potential sites
• Participate and/or lead in the development of Clinical Operations Standard Operating Procedures (SOP) and training materials.
• Manage study activities to ensure compliance with protocols, ICH/GCP, and global regulatory guidelines. Ensure legal, ethical, efficient, and professional conduct of studies.
• Manage and oversee project delivery, including monitoring progress, agreed-upon timelines and deliverables, project finances, and expenditures.
• Manage budget negotiations with sites and vendors, track expenses, ensure accuracy of invoices submitted for payment, and ensure alignment of resources and budget across programs through evaluation of timelines and task prioritization.
• Supervise vendor selection process, manage vendors, including clinical and analytical Contract Research Organizations (CROs).
• Lead the operational development of study documents and tools, including but not limited to protocols, consent forms, project plans, budgets, and other necessary documents such as Data Monitoring Plan, Safety Monitoring Plan, Medical Data Review Plan, Safety Monitoring Committee Charter, Investigator’s Brochure, and Development Safety Update Report.
• Implement and oversee Trial Master File and other requirements for inspection readiness, such as quality and financial audit certificates.
• Organize and lead operational aspects of training sessions for clinical study teams on protocol-specific topics.
• Provide study updates, including identifying risks and issues, while working with necessary teams towards a resolution.
• Recommend and implement innovative processes to improve clinical trial management and deliverables, including contingency plans.
• Oversee operational aspects of ongoing data reviews and data cleaning activities.
• Provide oversight of activities related to site identification, qualification, selection, initiation, monitoring, and close-out activities.
• Support audits of sites and vendors.

• Bachelor’s degree (or equivalent) in a relevant scientific field preferred.
• Minimum of 7 years of clinical trial experience, including clinical trial management and clinical monitoring in pharmaceutical, biotech, academic medical center or CRO setting; oncology and/or immunology study experience preferred.
• ICH/GCP Training
• 5+ years of experience in clinical program management.
• Experience managing Phase 1-2 trials, knowledge of clinical operations, ICH/GCP, and regulatory requirements; experience with First-in-Human studies preferred.
• Th…