Clinical Scientist: Associate Director & Senior Manager, Tokyo

CSL Behring is seeking talented Clinical Scientists to join our Clinical Development Japan team. We currently have two open positions:

• Clinical Scientist, Associate Director
• Clinical Scientist, Senior Manager

Both roles play an important part in advancing clinical development programs in Japan, partnering with global and local stakeholders to support the development of innovative therapies for patients. The Associate Director role carries broader responsibility for Japan clinical development strategy, program leadership, and mentoring of colleagues.

About the role

As a Clinical Scientist, you will provide scientific expertise across clinical development activities, supporting study design, clinical data review and interpretation, regulatory submissions, and cross-functional collaboration. You will work closely with Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, Medical Affairs, and Global Development teams to help deliver successful development programs in Japan.

Key Responsibilities

• Provide scientific leadership and expertise for clinical development programs and studies.
• Contribute to the design, development, execution, analysis, and reporting of clinical studies.
• Review and interpret clinical efficacy, safety, biomarker, and clinical trial data.
• Develop and review key clinical and regulatory documents, including protocols, study reports, investigator brochures, informed consent forms, and submission materials.
• Partner with Regulatory Affairs to support PMDA consultations, regulatory submissions, and responses to health authority questions.
• Collaborate with global and local cross-functional teams to ensure successful program execution.
• Build relationships with investigators, key opinion leaders, and external experts to gather scientific insights
• Ensure all activities are conducted in accordance with applicable regulations, ICH-GCP, and CSL quality standards

About you

You will bring strong scientific expertise, clinical development knowledge, and the ability to effectively work within a global matrix environment.

Qualifications, Skills & Experience

• Bachelor's degree or higher in Medicine, Pharmacy, Pharmaceutical Sciences, Biological Sciences, or a related life sciences discipline.

• Experience in pharmaceutical or biotechnology clinical development, clinical research, medical affairs, regulatory affairs, or related functions.

• Experience supporting clinical studies, protocols, clinical data review, and regulatory documentation.

• Knowledge of ICH-GCP and Japanese clinical development and regulatory requirements.

• Strong analytical, scientific communication, and stakeholder management skills.

• Professional-level Japanese and business-level English language capability.

Additional Experience for Associate Director

In addition to the above, candidates applying for the Associate Director position should bring:

• Extensive experience leading clinical development programs, studies, or major workstreams
• Demonstrated ability to influence clinical development strategy and provide scientific leadership across complex programs
• Experience supporting regulatory interactions and PMDA consultations
• Proven capability to mentor colleagues and lead cross-functional initiatives
• Experience representing local development needs within global matrix teams and influencing strategic decision-making

Please note that these are two separate vacancies. Candidates will be assessed against the requirements for either the Senior Manager or Associate Director position based on their experience and capabilities.