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About the Role
The Clinical Development Lead (CDL) is responsible for the Japan clinical development plan for assigned projects, ensuring studies meet Japan-specific requirements from clinical, regulatory, and operational perspectives. The CDL leads communication with external stakeholders and is accountable for clinical and regulatory documents.
Responsibilities
- Develops Integrated Development Plan (IDP) and defines Japan clinical development strategies.
- Provides disease landscape, SOC, KMEs, and competitor information to the Project Team.
- Integrates scientific rationale, regulatory requirements, operational feasibility, product development plan, and commercial goals for the Japanese components of the IDP.
- Leads clinical development strategy discussions, ensuring alignment with global strategy.
- Owns and leads clinical studies in assigned projects, ensuring protocol applicability to Japanese medical practice.
- Manages local protocol amendments.
- Secures necessary resources and budget for trial execution in collaboration with the CTM.
- Accountable for study feasibility, CRO and vendor selection, and study budget in Japan.
- Identifies study-level risks and drives mitigation strategies.
- Solves study-related issues in Japan, including AE management.
- Maintains study quality and educates study team members on protocols.
- Leads medical and scientific discussions with investigators and KMEs as a Biogen Japan clinical representative.
- Serves as a local clinical representative in regulatory interactions in Japan.
- Prepares and/or reviews clinical contents of regulatory submission documents and responses to inquiries.
- Participates in regulatory consultations and discussions.
- Establishes and maintains scientific reputation in academic societies through conference participation and presentations/publications.
Requirements
- Science background and education (Bachelor’s Degree or equivalent), MD/PhD/PharmD preferred.
- Strong clinical credentials and/or drug development experience in therapeutic areas, with a grounding in scientific research.
- At least 3 years of clinical development experience within the biopharmaceutical industry in product development.
- Experience working with regulatory agencies (PMDA experience preferred).
- Ability to lead scientific discussions on new research approaches, clinical endpoints, protocol design, and data interpretation.
- Established or ability to establish peer-level relationships with therapeutic area opinion leaders worldwide.
- Demonstrated leadership and team-building skills.
- Ability to perform effectively in a dynamic environment.
- Demonstrated strategic and critical thinking.
- Excellent communication skills (oral and written) with business-level English.
- Excellent organizational skills.
- Ability to lead directly and by influence.
- Strong problem-solving, conflict resolution, and analytical skills.
Skills
- Clinical development
- Regulatory affairs
- Project management
- Scientific research
- Data interpretation
- Leadership
- Team building
- Strategic thinking
- Critical thinking
- Communication
- Organizational skills
- Problem-solving
- Conflict resolution
- Analytical skills
Location
- Japan
Work Type
- Full-time
Experience Level
- Management
- 3+ years in product development
Education Level
- Bachelor's Degree
- MD/PhD/PharmD preferred
About the Company
- Biogen is a global biotechnology company committed to excellence and a pioneering spirit.
- As a mid-sized company, Biogen offers the stability and resources of an established business while fostering an environment where individual contributions have a significant impact.
- The team comprises talented and passionate achievers with unparalleled opportunities for learning, growth, and skill expansion.
- Biogen works together to deliver life-changing medicines, with every role playing a vital part in its mission.
- Biogen is committed to building a culture of inclusion and belonging that reflects the communities it serves.
- Diverse backgrounds, cultures, and perspectives are valued to foster a stronger and more innovative company.
- Biogen is an E-Verify Employer in the United States.
Equal Opportunity
- All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.