Innovative Global Oncology Biotech company seeking a Head of Clinical Operations.This clinical stage biopharmaceutical company with the scientific vision of revolutionizing the cancer treatment in various indications is moving ahead with strong clinical advancements. Company specializing in the cell therapy/CAR-T area. Both Phase II and IIl clinical development programs successfully underway. The company has built up robust operational and supply chain capabilities to successfully delivery autologous T cell therapy treatments to a large patient pool across global countries.
- Provide strategic and operational expertise for the timely, quality preparation and execution of company’s multi-country sponsored clinical development programs (Phases 1 – 3).
- Accountable for the implementation and execution of Clinical Operations product-specific strategic and tactical plans.
- Ensure the effective and constructive integration of clinical operations knowledge and expertise into all applicable clinical development activities including integrated development plans and study protocols; interact and collaborate with other department heads as appropriate.
- Ensure consistent and successful execution of all operational aspects of global studies as appropriate, data delivery and reporting.
- Plan and implement Quality Checks for clinical projects and provide leadership and direction to ensure the highest standards for compliance with Company SOPs, ICH-GCP guidelines,
- Accountable for the authorship of operational sections of protocols and investigator brochures and leading the identification of and interaction with investigative sites, including study execution.
- Develop and maintain strong relationships with CROs, and investigators to ensure effective execution of internal and external clinical projects.
- Responsible for the management and leadership of all staff within the Clinical Operations group including recruitment, training, career development and performance evaluations.
- Bachelors or advanced degree (Ph.D. or Pharm.D.) in scientific/life-sciences or related field.
- 10+ years of clinical operations experience in pharmaceutical/drug development, with a preference for biologics experience, and including 5+ years of experience in study management.
- Proven track record of planning, conducting & managing clinical operations for Phase 1-3 studies
- In-depth understanding and experience across the clinical operations value chain, with a track record of success in study planning, execution, data cleaning, database locking, study report generation and regulatory inspection.
- Experience in Oncology trials is required.
- Demonstrates advanced knowledge of design and phases of Oncology clinical studies on a global scale, global regulatory issues, CRO operations, and compliance practices.
- Ability to work in a very dynamic environment, handle a high volume of highly complex tasks within a given timeline.
- Thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical trials, clinical study design, and data management methods.
- Experience in conducting trials in EU is an advantage and desired.
- Ability to travel US and globally up to 20%-25% of the time.
up to $255K+ plus Annual Bonus + Stock Equity Options
No, not at this time.
LT - 3113