Clinical Program Manager

Responsibilities

• Lead the successful development, implementation, and management of clinical trials from inception to completion
• Manage CROs and vendors, including the development of RFPs and ongoing performance evaluation
• Author and review critical clinical documentation, including study protocols, clinical study reports (CSR), investigator brochures, and regulatory filings such as IND and NDA
• Ensure all clinical activities comply with FDA/EMEA regulations, ICH Guidelines, and GCP standards
• Mentor and develop junior staff while providing clear strategic direction for clinical programs
• Contribute to the development, implementation, and training of Standard Operating Procedures (SOPs)
• Participate in and lead departmental or interdepartmental strategic initiatives

Requirements

• 8+ years of experience in clinical development or clinical operations
• BS or BA in a relevant scientific discipline
• RN certificate (2 or 3 year program) or equivalent clinical experience
• Deep expertise in FDA/EMEA regulations, ICH Guidelines, and GCP
• Proven experience in CRO and vendor management
• Strong interpersonal, leadership, and communication skills

About the Company

Gilead is a research-based biopharmaceutical company that has spent over 35 years tackling major diseases such as HIV, viral hepatitis, COVID-19, and cancer. We are dedicated to developing life-changing therapies and ensuring global access to improve the lives of patients everywhere.