Join a leading healthcare commercialization platform as the Head of Clinical Development, reporting directly to the CEO. This role involves leading clinical development, regulatory strategy, and compliance efforts for pharmaceuticals, cell therapies, and medical devices. You will manage cross-functional teams, oversee PMDA interactions, and drive clinical execution and strategic growth.
Key Responsibilities
- Leadership & Team Management: Lead and develop teams in Regulatory, Clinical, Quality, and Safety, ensuring alignment with corporate objectives.
- Regulatory & Compliance Oversight: Manage PMDA interactions, maintain regulatory licenses (業許可), and ensure compliance across pharmaceuticals, cell therapies, and medical devices.
- Clinical & Regulatory Strategy Execution: Develop and execute regulatory and clinical strategies, manage CRO partnerships, and ensure high clinical trial standards.
- Quality, Safety & Pharmacovigilance: Oversee quality assurance, safety, and pharmacovigilance, keeping up with global and Japanese regulatory trends.
- Stakeholder & Partner Collaboration: Engage with KOLs, corporate leadership, and overseas business partners to shape corporate and clinical strategies.
- Due Diligence & Business Support: Support commercial teams by evaluating business opportunities from regulatory and safety perspectives.
- Department Growth & Strategic Development: Plan budgets, enhance departmental capabilities, and align clinical development with high-growth business strategies.
Required Skills and Qualifications
- Education:
- Bachelor's degree in Life Sciences, Medicine, or a related field (required).
- Experience:
- 10+ years in the pharmaceutical industry with a strong background in clinical development and regulatory affairs.
- Experience working closely with clinicians in an industry setting or as a clinician.
- Proven ability to lead and develop teams within a corporate environment.
- Strong understanding of medical science, business analytics, and clinical research planning.
- General Marketing Authorization Holder (GMAH) experience for pharmaceuticals.
- Language Proficiency:
- Japanese: Native level (required for regulatory compliance and stakeholder communication).
- English: Business level (for global collaboration and reporting).
Preferred Skills & Qualifications
- M.D. or Ph.D. in Life Sciences or a related field.
- Knowledge of pre-clinical development requirements and regulatory submission planning.
- Licensed pharmacist with 3+ years of experience in quality control or post-marketing safety management.
Why You'll Love Working Here
- Broader impact across multiple innovations in biotech, pharma, and medical devices.
- Exposure to diverse overseas partnerships and global market expansion.
- Opportunity to build and lead an entire Clinical Development Team.
- Greater autonomy and strategic influence in regulatory and clinical planning.
About the Company
Our client is a leading healthcare commercialization platform, helping biotech, medical device, and pharmaceutical firms navigate Japan's regulatory landscape and market entry. With strong industry ties and a proven track record, the company streamlines clinical development and approvals, enabling efficient, compliant product launches in Japan and the broader Asia-Pacific region.
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