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About the Role
Senior clinical development role responsible for the clinical strategy and development of assigned assets in Japan. Ensures clinical programs align with Japan-specific medical and regulatory requirements to generate evidence for successful regulatory approval.
Responsibilities
- Lead Japan clinical development strategy across early, late-stage, and post-marketing studies.
- Provide clinical input into study design, protocols, execution, and data analysis.
- Ensure global clinical programs are appropriate for Japanese medical practice and regulatory requirements.
- Lead clinical discussions with KOLs, investigators, and external scientific partners.
- Serve as a key clinical representative in regulatory interactions and support regulatory submissions.
- Review and interpret clinical data, identify risks and trends, and support clinical decision-making.
- Oversee clinical activities for Japan-specific studies from study start-up through completion.
- Work closely with Clinical Operations, Regulatory, Statistics, Medical, and Global teams in a matrix environment.
- Contribute to clinical strategy and ensure the development program supports a viable registration strategy in Japan.
- Coach and develop junior Clinical Leads.
Requirements
- 5+ years of clinical development / pharmaceutical industry experience preferred.
- Strong experience in clinical trial design, execution, and data interpretation.
- Strong understanding of drug development, GCP/ICH, clinical operations, and statistics.
- Experience developing clinical strategies and working within cross-functional/matrix organizations.
- Ability to influence and collaborate with senior stakeholders without direct authority.
- Strong problem-solving and decision-making skills.
- Ability to work effectively in complex and changing environments.
- Business-level English preferred.
Experience Level
- Senior