DIRECTOR, CLINICAL OPERATIONS

DESCRIPTION

RESPONSIBILITIES

• Clinical Trial Management: Oversee the tactical planning and drive initiation, execution, and completion of clinical trials. Manage the operational aspects of clinical trials, including site selection, patient recruitment, monitoring, and data collection.
• Vendor and CRO Management: Evaluate, select, and manage, external partners such as Contract Research Organizations (CROs), Labs, and other third-party vendors. Ensure vendors meet operational, regulatory, and quality standards.
• Regulatory and Compliance Oversight: Ensure clinical trials are conducted in compliance with applicable regulations, including GxP, ICH, and FDA guidelines. Prepare and review clinical trial documents, such as protocols, informed consent forms, investigator brochures, and essential documents. Oversee CRA activities and review monitoring reports. Work in collaboration with GCP QA.
• Budget and Resource Management: Develop and manage budgets for clinical trials, including the allocation of resources, cost forecasting, payment management, and ensuring that trials stay within budget.
• Risk Management: Identify and mitigate risks to study timelines and quality, proactively manage issues, and ensure timely escalation of critical issues.
• Data Integrity and Safety: Ensure the integrity of clinical trial data and that patient safety is a top priority throughout the course of all studies. Oversee the safety monitoring and reporting processes. Provide guidance and support for data management, support implementation and management of key tools and systems such as EDC, IRT, CTMS, and any other applicable system.  Work with Data Management and other departments to facilitate the analysis and reporting of study results.
• Clinical Trial Documentation: Ensure accurate and timely collection and documentation of clinical trial data. Oversight of TMF and documentation plans.

• Bachelor’s degree in Life Sciences, Nursing, or related field (required).
• Master’s degree or higher (preferred).
• Minimum of 10 years of experience in clinical operations within the biotechnology or pharmaceutical industry, with at least 2 years in a leadership role.
• Proven experience in managing global clinical trials across multiple phases of clinical development.
• Expertise in oncology clinical trials is strongly preferred.
• Expertise in rare disease clinical trials preferred.

• In-depth understanding of clinical trial methodologies, design principles, and the regulatory frameworks that govern clinical development, including GxP, ICH, and FDA guidelines.
• Proven ability to drive the successful execution of clinical trials, ensuring efficient processes, effective resource utilization, and adherence to timelines and budgets.
• Expertise in managing third-party relationships, including selecting and overseeing CROs and other external partners, ensuring the high-quality execution of studies and maintaining compliance with agreed-upon standards.
• Skilled at identifying potential challenges early in the clinical trial process, proactively managing risks, and finding solutions to ensure continuous study progress.
• Strong ability to articulate complex clinical data and study outcomes to diverse audiences, including internal stakeholders, regulatory bodies, and external partners, ensuring clarity and understanding across all levels.

• Competitive salary and benefits package.
• Opportunity for professional development and career advancement.
• A supportive and innovative work environment.
• Access to cutting-edge technology and research tools.

AT INCENDIA, we strive to build a diverse and equitable workplace