The Director of Clinical Operations will play a pivotal role in guiding the design and implementation of clinical trials sponsored by BiomX. This position entails overseeing several outsourced clinical research programs with a focus on combating bacterial infections, particularly those caused by multi-drug resistant pathogens. The Director of Clinical Operations will be responsible for the successful execution of various clinical programs involving BiomX’s products. They will ensure that BiomX-sponsored clinical trials are conducted efficiently within established timelines and budgets, while upholding the highest standards of quality in accordance with Good Clinical Practice international standards.
This role demands active leadership in all operational facets of clinical testing for groundbreaking biopharmaceutical drugs at a company deeply committed to enhancing patient outcomes. The incumbent will provide strategic leadership and operational guidance for all regulated clinical programs aimed at securing global marketing approval. This position requires a hands-on approach, with the opportunity to make a tangible impact on the lives of patients.
Essential Functions:
- Support the planning and implementation of clinical training, ensuring ongoing oversight and continuous training throughout active clinical trials. Coordinate and manage all clinical operational activities across assignments.
- Lead and manage clinical operations staff, including external consultants and outsourced clinical research organization personnel responsible for clinical monitoring and data management of clinical trials. Ensure the delivery of high-quality operational results while maintaining consistency in processes and approaches.
- Assist in overseeing, drafting, and reviewing regulatory documents for submission to regulatory authorities, such as NDAs, INDs, annual reports, and responses to inquiries from regulatory authorities and institutional review boards/ethics committees.
- Define and oversee clinical trial plans across a range of infectious disease target areas.
- Manage Contract Research Organizations (CROs) effectively to ensure that clinical studies are conducted to the highest quality standards, delivered on time, and within budget. Take responsibility for clinical project timelines and budgets.
- Facilitate the completion of study-specific procedures and plans generated by CROs, partners, or BiomX.
- Collaborate effectively with cross-functional teams to ensure the timely delivery of clinical trial materials to clinical sites and contribute to the development of procedures for managing clinical samples for laboratory testing.
- Demonstrate a strong understanding of FDA and other regulatory authority requirements that impact clinical studies.
- Develop internal systems to ensure that clinical studies are conducted in compliance with current regulations and to prepare the company adequately for audits and inspections by government sponsors, FDA, and international regulatory authorities.
- Oversee the selection process for CROs, clinical trial sites, potential investigators, and external contractors. Monitor and evaluate clinical site performance as necessary.
- Oversee and contribute to the development of department Standard Operating Procedures (SOPs) to ensure that company policies and procedures align with current international regulations and guidelines.
- Ensure compliance with study plans through the review of data reports and outputs, including Key Performance Indicators (KPIs), identified risks, and trends using outputs from monitoring activities and functional groups, as applicable.
- Take responsibility for clinical quality management, including identifying quality issues, conducting root cause analysis, developing and executing Corrective and Preventive Actions (CAPAs), and managing risks in real time.
- Support the development, implementation, and improvement of appropriate and standardized processes, systems, and tools across the Clinical Operations function in collaboration with other relevant departments.
- Prepare and review Requests for Information (RFIs) and Requests for Proposals (RFPs) for clinical vendors, including CROs and consultants.
- Provide support for expedited Investigational New Drug (eIND) cases, if required, to ensure the timely delivery of life-saving phage treatment and appropriate data tracking.
- Monitor and manage the progress of clinical studies and deliver senior-level briefings to senior management.
- Participate in the review and development of clinical trial plans (e.g., Monitoring Plan, Blinding Plan, Project Management Plan, Data Management Plan, Risk Assessment and Mitigation Plans, etc.).
- Conduct periodic reviews of data listings and outputs from Electronic Data Capture (EDC) systems to address data quality or integrity issue
- Support Pharmacovigilance activities and safety reviews by ensuring the implementation of adequate SOPs, processes, and assessments to protect patient safety