About the Company - Join a forward-thinking biopharmaceutical company dedicated to developing innovative therapies for life-threatening diseases who are currently seeking a Director of Clinical Operations to join their dynamic team and drive their mission forward.

About the Role - The Director of Clinical Operations plays a pivotal role in the clinical development efforts. This role encompasses oversight of clinical trials, ensuring adherence to regulatory standards, and promoting operational excellence. The leadership of the Director of Clinical Operations is essential to the successful delivery of life-changing treatments to patients in need.

Responsibilities

• Provides comprehensive oversight and management of clinical operations, encompassing study planning, execution, and closeout activities.
• Offers strategic guidance to cross-functional clinical teams to ensure the successful achievement of study objectives.
• Ensures strict compliance with all applicable regulations, ICH-GCP guidelines, and company policies.
• Manages study budgets, timelines, and resource allocation to achieve defined study goals.
• Establishes and fosters robust relationships with study investigators, clinical research organizations, and external partners.
• Communicates transparently about study progress and shares results with senior leadership and key stakeholders.
• Leads, mentors, and develops the clinical operations team, setting and maintaining high-performance standards.

Qualifications

• Holds a Bachelor's or advanced degree in a relevant scientific or healthcare field.
• At least 8 years of experience in clinical operations, demonstrating a proven track record in managing clinical studies.
• Ideally 5+ years' experience oncology, immunology, and/or neurology fields.
• Demonstrates in-depth knowledge of ICH-GCP and other relevant regulatory guidelines.
• Exhibits strong leadership and communication skills, with a demonstrated ability to collaborate effectively across various functions.
• Has experience in budget management, resource allocation, and oversight of vendors.
• Leadership experience in an FSP model.
• Is dedicated to patient safety and the delivery of high-quality clinical research.
• Able to work in office 3 days a week.

Benefits

• A competitive compensation package.
• Comprehensive benefits, including medical, dental, and vision coverage.
• Opportunities for professional development and growth.
• A collaborative and innovative work environment.
• The chance to make a meaningful impact on the lives of patients through groundbreaking research and therapies.