Japan Program Clinical Head (CRM)

About the role

The Japan Program Clinical Head (JPCH) is responsible for clinical program activities covering approval and post-approval commitments for re-examination in Japan. The role covers one or more clinical programs across indications and compounds, working closely with the Japan Project Head and the Global Program Clinical Head, and contributing to the design, implementation and execution of clinical development programs from a Japanese perspective.

Key responsibilities

• Act as an extended member of the Global Clinical Team representing Clinical Development Japan, and as a member of the Japan Program Team driving clinical development in Japan.
• Lead Japan clinical strategy after the Decision Point, and provide Japan inputs to the Global Program Clinical Head on the Clinical Development Plan aligned with the Target Product Profile.
• Contribute Japan input to clinical components of key documents such as protocols, investigator's brochures, clinical study reports and regulatory dossiers, including re-examination applications, value and pharmacoeconomic dossiers.
• Support registration, market access, commercialization and maintenance of product licenses (e.g. core data sheet, periodic safety update report, J-RMP).
• Represent the company in interactions with Japanese regulators, key opinion leaders, data monitoring committees, advisory boards and patient groups, and prepare briefing books for health authority questions.
• Contribute to therapeutic area strategy (Rheumatology) and to the development of clinical standards, publications and presentations.
• Mentor and coach colleagues, ensure timely reporting of adverse events and compliance issues, and deliver training on time.

Required profile

• Advanced degree in life sciences or healthcare (MD, PhD or PharmD preferred); specialization in a subspecialty may be needed.
• At least 5 years of clinical research or drug development experience in an industry setting, covering phases I through IV and submission dossiers (equivalent medical experience for MD holders).
• Thorough knowledge of GCP, clinical trial design, statistics and regulatory processes, and experience with submissions and health authorities.
• Demonstrated leadership, team management and cross-functional collaboration, with strong communication and negotiation skills.
• Fluent or intermediate oral and written English.