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.

Responsibilities:

• 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.
• 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.

Experience:

• Ideally a postgraduate in life sciences with at least 15 + years of experience in clinical research roles (operational or quality), preferably including both CRO and sponsor company experience
• Significant experience related to the management and oversight of clinical studies at both early and late stage development
• Demonstrates flexibility and adeptly manages multiple tasks to meet deadlines, consistently delivering high-quality work in a dynamic environment.
• Possesses an excellent working knowledge of ICH-GCP guidelines.
• Willing to engage in hands-on operational tasks as required by project demands.
• Exhibits strong presentation, documentation, and interpersonal skills, with a collaborative team-oriented approach.
• Displays strategic thinking with exceptional problem-solving and decision-making abilities.
• Proven self-starter capable of working independently and adapting quickly within a rapidly evolving environment.
• Experience working for a Sponsor company