Seoul, KOR
3 days ago
CPM / AD, Clinical Operations Korea
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. **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/PharmD/PhD 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. **For Current Gilead Employees and Contractors:** Please apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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