Job Description

Job Description

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.

POSITION OVERVIEW:

As Director of Clinical Development at Kite Japan, you will play a pivotal leadership role in advancing clinical development efforts for innovative cell therapies, including CAR-T. You will be responsible for shaping and executing clinical and regulatory strategies in Japan, including leading the development of clinical development strategies and the planning and submission of the Japanese New Drug Application (JNDA). This role requires close collaboration with cross-functional teams and global stakeholders to ensure the successful execution of clinical programs and regulatory milestones in Japan.

In this role, you will serve as the key clinical representative for Japan, working closely with cross-functional teams and global stakeholders to ensure alignment with global development plans while addressing local regulatory and medical needs. You will provide scientific and clinical leadership throughout the clinical development process—from strategic planning, study concept and protocol design, and trial execution, to data interpretation and regulatory submissions—ensuring timely and high-quality delivery of clinical milestones.

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.
• Lead the planning, coordination, and submission of the Japanese New Drug Application (JNDA), including preparation of regulatory documents and interactions with PMDA.
• 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.
• Provide ongoing clinical oversight for clinical trials, including eligibility assessments, safety monitoring, and toxicity management.
• Collaborate with regulatory affairs to prepare for and participate in PMDA consultations and other regulatory interactions.
• 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, PharmD, or PhD in clinical research or a relevant scientific field, with 8+ years of scientific and/or drug development experience in the pharmaceutical industry.
• MS with 10+ years, or BS/RN with 12+ years of relevant scientific and/or drug development experience in the pharmaceutical industry.
• Extensive experience leading cross-functional teams within clinical development in the pharmaceutical industry.
• Experience in oncology, hematology, or cell therapy is highly preferred.
• Proven track record in leading clinical development programs and regulatory submissions in Japan.
• Demonstrated experience in developing and executing clinical development strategies in Japan—including taking the lead on study concept and protocol design—and a proven track record of leading JNDA submissions are required.
• Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.

Knowledge & Other Requirements

• Deep understanding of Japan’s regulatory landscape and clinical trial requirements.
• Strong analytical and problem-solving skills.
• Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
• Excellent communication and interpersonal skills, with fluency in both Japanese and English.
• Ability to effectively communicate with internal and external stakeholders, including regulatory authorities and global teams.
• Willingness to travel as needed.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

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