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About the Role

Provides global or regional leadership for a particular regional or global clinical program, ensuring the design and execution of high-quality clinical studies to guarantee product safety and effectiveness. Manages clinical project team members for timely project completion and oversees project timeline development and maintenance.

Responsibilities

• Responsible and accountable for several concurrent clinical studies for multiple programs and therapeutic areas.
• Leverages resources, expertise, and knowledge across projects to ensure deliverable attainment.
• Develops staffing plans to align resources with workloads.
• Hires, trains, develops, mentors, and supervises managers and clinical staff.
• Participates in and assists in the development of global clinical strategies for assigned therapeutic area(s) in collaboration with regulatory affairs, marketing, research & development, reimbursement and outcomes planning, and regions.
• Supports regulatory/clinical strategies as the clinical representative for the therapeutic area or region.
• Oversees the preparation and management of budgets for projects in therapeutic area.
• Negotiates contracts and budgets with sites and vendors.
• Reviews and approves protocols for projects.
• Reviews final study conduct documents such as study manuals, study tools, etc.
• Drafts, reviews, and approves instructions for use for investigational devices.
• Attends investigator and coordinator meetings, representing the region.
• Provides oversight of individual clinical trials to ensure safety concerns and/or adverse events are identified and appropriate responses are developed and executed.
• Provides advice on the reportability of adverse events and other clinical trial issues to regulatory agencies.
• Determines membership criteria and identifies potential members for clinical events committees and data monitoring committees.
• Reviews and approves trigger plans for Clinical Event Committee and Data Monitoring Committee.
• Manages data release and review meetings for projects in therapeutic area.
• Reviews and participates in finalizing and approving final manuscript or final reports for projects.
• Participates in the dissemination of clinical information to clinical team members and extended core team members.
• Reviews and approves corrective action plans at individual sites and across study.
• May participate in internal/external study-related audits.
• Develops and maintains Clinical Affairs infrastructure such as drafting and/or reviewing Divisional Work Instructions and local Instructions.
• Demonstrates thorough knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable company’s SOPs and policies.

Requirements

• 10+ years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials.
• 5+ years experience managing projects and working with clinical professionals within a team.
• 5+ years experience working in a cross-functional product development setting.

Location

• Japan > Tokyo : Hamarikyu Park Side Place 9F, 17F 5-6-10,Tsukiji,Chuo-ku

Work Type

• Standard
• Travel: Yes, 25 % of the Time

Experience Level

• 10+ years experience
• 5+ years experience

Education Level

• Bachelor’s degree or equivalent
• Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred.
• PhD-level degree (or equivalent), or qualification in medicine preferred.

Salary/Compensations

• N/A

About the Company

• JOB FAMILY: Clinical Affairs / Statistics
• DIVISION: MD Medical Devices