Clinical Operations Lead, Japan

About the role

We are hiring a Clinical Operations Lead to manage and expand our clinical services within the Japanese market. You will establish local governance frameworks, build a high-quality prescriber network, and ensure our care delivery meets both regulatory standards and patient needs. In this leadership capacity, you will own the end-to-end clinical workflow for our Japan operations, translating global standards into locally relevant practices. You will be responsible for safeguarding patient safety while driving the strategic growth of our clinical portfolio in the region. The role requires a proactive approach to identifying systemic risks and implementing robust mitigation strategies across all touchpoints. You will serve as the critical link between our global clinical leadership and the Japanese healthcare ecosystem, ensuring alignment and execution. Success in this position will be defined by your ability to build trust with stakeholders and deliver measurable improvements in care quality and operational efficiency.

Key facts

What you'll do

• Lead clinical strategy for market entry and new product launches in Japan, conducting comprehensive environmental scans and gap analyses.
• Recruit, onboard, and manage a high-performing network of local prescribers, establishing clear performance expectations and career pathways.
• Design clinical protocols, safety guardrails, and escalation pathways compliant with Japanese healthcare laws, ensuring all documentation is rigorously reviewed.
• Monitor clinical performance through data analysis, audits, and incident management, identifying trends and implementing corrective actions promptly.
• Act as the primary clinical subject matter expert for cross-functional teams and external stakeholders, providing clear, evidence-based guidance.
• Localize clinical content and patient education materials, ensuring linguistic accuracy and cultural relevance for diverse patient populations.
• Represent the company at industry events and build relationships with local regulatory bodies, staying informed on evolving policy landscapes.
• Develop and implement training programs for clinical staff, focusing on best practices and regulatory compliance specific to the Japanese market.
• Establish key performance indicators for clinical operations, tracking progress and reporting insights to leadership for strategic decision-making.
• Conduct regular reviews of vendor and partner interactions to ensure adherence to clinical standards and contractual obligations.
• Drive the continuous improvement of clinical documentation processes, optimizing workflows for efficiency and regulatory compliance.
• Collaborate with product teams to provide clinical feedback during the development phase, ensuring feasibility and safety from a healthcare perspective.
• Oversee the management of clinical inquiries and cases, ensuring timely, accurate, and compassionate resolution for patients and providers.
• Champion data integrity and privacy protection, ensuring all clinical data handling practices exceed minimum legal requirements.

Requirements

• Current professional healthcare license in Japan (physician, pharmacist, or allied health professional), valid and in good standing.
• Deep knowledge of the Japanese healthcare system, local regulations, and prescribing standards, including recent reforms and updates.
• Proven experience in clinical operations, digital health, or healthcare strategy, with a track record of successful project execution.
• Ability to scale processes and teams in a fast-paced environment, demonstrating flexibility and resilience under pressure.
• Native-level fluency in Japanese and professional proficiency in English, with exceptional written and verbal communication skills.
• Demonstrated ability to work independently and as part of a distributed team, managing priorities with minimal direct supervision.
• Strong understanding of ethical standards and compliance requirements relevant to clinical research and patient care in Japan.
• A meticulous attention to detail, ensuring accuracy in all clinical documentation, reports, and deliverables.

Skills & tools

• Clinical governance and risk management frameworks to ensure safe and effective service delivery.
• Stakeholder and regulatory relations expertise, fostering collaborative partnerships with key external entities.
• Performance management and workforce scaling methodologies to build and sustain high-performing clinical teams.
• Data-driven quality improvement techniques to enhance clinical outcomes and operational efficiency.
• Project management methodologies to coordinate timelines, resources, and cross-departmental initiatives.
• Advanced analytical skills to interpret complex datasets and derive actionable insights for strategic planning.
• Excellent communication and presentation skills to convey complex clinical information to diverse audiences.
• Proficiency in utilizing digital tools and platforms to streamline clinical workflows and documentation.

Practical notes

• Benefits include wellness budgets, mental health support via an Employee Assistance Program, annual health checks, and flu shots.
• The company provides learning budgets, including support for language acquisition.
• A work-from-anywhere policy is in place.
• All applications are reviewed by human recruiters, though AI tools are utilized for administrative efficiency.
• This role is based in Tokyo, Japan, requiring residency and the ability to work onsite at the headquarters location.
• The engagement is full-time, requiring a standard weekly commitment as determined by operational needs.
• Candidates must be available to participate in onboarding and training schedules as defined by the company's global onboarding procedures.
• Travel may be required for stakeholder meetings, industry conferences, and regulatory visits within the region.
• Visa sponsorship considerations will be evaluated based on specific candidate qualifications and role requirements.
• Applications will be processed on a rolling basis, and early application is strongly encouraged to secure consideration for the role.
• The company is an equal opportunity employer, welcoming diverse candidates who are committed to excellence in clinical operations.