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About the Role
Gilead is dedicated to creating a healthier world by tackling diseases like HIV, viral hepatitis, COVID-19, and cancer. We are seeking passionate and ambitious individuals to join our mission and make a direct impact. As a people leader, you will be instrumental in evolving our culture and fostering an inclusive environment where employees are developed and empowered.
Responsibilities
- Lead the development and execution of clinical development strategies in Japan, ensuring alignment with global plans and addressing local needs.
- Serve as the clinical lead for Japan in cross-functional teams, providing strategic and scientific input.
- Provide scientific and clinical guidance to cross-functional teams for timely and high-quality milestone delivery.
- Develop and maintain the Target Product Profile (TPP) and Clinical Development Plan (CDP).
- Design and review clinical trial protocols, clinical study reports, and responses to health authority inquiries, including the CTN submission in Japan.
- Provide ongoing medical monitoring for clinical trials, including eligibility assessment, toxicity management, and safety monitoring.
- Collaborate with regulatory affairs for PMDA consultations and other regulatory interactions.
- Lead the planning, coordination, and submission of the Japanese New Drug Application (JNDA).
- Analyze and interpret clinical data, and contribute to internal reviews, publications, and scientific presentations.
- Represent Kite at scientific conferences and investigator meetings.
- Ensure compliance with GCP, local regulatory requirements, and internal SOPs.
Requirements
- MD with 5+ years’ drug development experience in the biopharma industry, healthcare, academia, or a related environment.
- Experience in the biopharma industry is preferred.
- Experience in oncology, hematology, or cell therapy is highly preferred.
- Significant experience working with and leading cross-functional project/program teams.
- Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
- Demonstrated excellence in complex project management and managing multiple clinical project deliverables and priorities through matrix management and leadership.
- Thorough understanding of pharmaceutical regulatory requirements and their impact on clinical trials in Japan.
- Strong analytical and problem-solving skills.
- Core expertise in the assigned or related disease area.
- Strong communication and organizational skills.
- Demonstrable ability to effectively communicate project direction and status to varying organizational levels.
- Fluency in both Japanese and English.
- Willingness to travel as needed.
Skills
- Drug development
- Clinical development strategies
- Cross-functional team leadership
- Scientific and clinical guidance
- Target Product Profile (TPP) development
- Clinical Development Plan (CDP) development
- Clinical trial protocol design
- Clinical study report writing
- Health authority inquiry response
- Medical monitoring
- Regulatory affairs
- PMDA consultations
- Japanese New Drug Application (JNDA) submission
- Clinical data analysis and interpretation
- Scientific publications
- Scientific presentations
- GCP compliance
- Project management
- Matrix management
- Analytical skills
- Problem-solving skills
- Communication skills
- Organizational skills
Location
- Japan
Work Type
- Full-time
Experience Level
- 5+ years drug development experience
Education Level
- MD
About the Company
- 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.