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.
Key RESPONSIBILITIES:
Lead the development and execution of clinical development strategies in Japan, ensuring alignment with global plans while addressing local regulatory and medical needs.
Serve as the clinical lead for Japan in cross-functional teams, providing strategic and scientific input across development stages.
Provide scientific and clinical guidance to cross-functional teams to ensure timely and high-quality delivery of clinical development milestones.
Develop and maintain the Target Product Profile (TPP) and Clinical Development Plan (CDP) for assigned products.
Design and review clinical trial protocols, clinical study reports, and responses to health authority inquiries, including the Clinical Trial Notification (CTN) submission in Japan.
Provide ongoing medical monitoring for clinical trials, including assessment of eligibility, toxicity management, and safety monitoring, with clinical oversight and data review to support patient safety and data integrity.
Collaborate with regulatory affairs to prepare for and participate in PMDA consultations and other regulatory interactions.
Lead the planning, coordination, and submission of the Japanese New Drug Application (JNDA), including preparation of regulatory documents and interactions with PMDA.
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:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Minimum Education & Experience
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 in life sciences, healthcare, or academia.
Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
Demonstrated excellence in complex project management and in effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.
Knowledge & Other Requirements
Has a thorough understanding of pharmaceutical regulatory requirements and their impact on development and execution of clinical trials in Japan.
Strong analytical and problem-solving skills.
Has core expertise in the assigned or related disease area, as evidenced by the ability to independently lead clinical development deliverables for one or more projects.
Strong communication and organizational skills. Demonstrable ability to effectively communicate project direction and status to varying organizational levels, including leadership teams.
F luency in both Japanese and English.
Willingness to travel as needed.
Please apply via the Internal Career Opportunities portal in Workday.
At Gilead, we set – and achieve – bold ambitions to create a healthier world for all people. From our pioneering virology medicines to our growing impact in oncology, we're delivering innovations once thought impossible in medicine. Our focus goes beyond medicines, and we also strive to remedy health inequities and break down barriers to care. We empower our people to tackle these challenges, and we’re all united in our commitment to help millions of people live healthier lives.
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