Job Description
POSITION OVERVIEW:
Responsible for the execution of Phase I-IV clinical trials (including PMS) across all Gilead therapeutic areas, ensuring compliance with SOPs, company policies, and regulatory guidelines. Oversee complex studies and programs, manage resources, and lead organizational change initiatives.
KEY RESPONSIBILITIES:
Strategic and Operational Planning: Provides input into short- and long-range plans for therapeutic/functional areas, ensuring alignment and communication with team members.
Leadership and Management: Offers leadership, guidance, and oversight for clinical trials, managing strategic, operational, and financial aspects of assigned programs.
Clinical Trial Execution: Develops, implements, and ensures completion of clinical trials within budgets and timelines, setting strategic vision and working cross-functionally with stakeholders.
Vendor Management: Assesses, on-boards, and manages CROs and other vendors, including handling RFPs and selection processes.
Program Implementation: Contributes to Clinical Development Programs, potentially serving on the Global Development Team, and leads cross-functional Study Management Teams.
Risk Mitigation and Problem Solving: Performs strategic analysis, implements risk mitigation strategies, anticipates obstacles, and solves regulatory and investigator interaction issues.
Communication and Documentation: Keeps stakeholders informed on project status and issues, uses tools to track and communicate program status, and contributes to study-related documentation and SOPs.
Compliance: Ensures team compliance with practices, policies, processes, and regulatory requirements.
People Leadership: Hires, develops, and retains top talent, sets clear expectations, coaches direct reports, and may develop other people leaders.
REQUIREMENTS:
Minimum Education & Experience
BA/BS/RN with 15+ years relevant clinical or related experience in life sciences, or MA/MS/Pharm D/Ph D with 10+ years relevant clinical or related experience in life sciences.
Minimum of 10 years cross-functional study management or related leadership experience in life sciences, including managing study management or project teams.
Experience developing RFPs and managing CROs or other vendors.
Proven ability to manage clinical studies within designated program budgets and timelines.
Expertise in authoring clinical study and regulatory documentation and SOPs.
Knowledge & Other Requirements
Expert knowledge of one or more disease or therapeutic areas (Oncology, Virology, and/or Inflammation)
Complete knowledge of full cycle study management.
Advanced knowledge of study management best practices and tools.
Thorough knowledge of FDA, EMA, ICH guidelines, and GCP.
Strong financial acumen for clinical trial budgets.
Proven ability to author clinical study and regulatory documentation.
Strong leadership presence with the ability to lead without authority.
Strong interpersonal skills and understanding of team dynamics.
Strong communication and organizational skills.
Strong negotiation and conflict resolution skills.
Demonstrated effectiveness in managing change.
Ability to travel as required.
Excellent verbal and written in Korean and English skills, and interpersonal skills are required.
