Philips Clinical Affairs Senior Manager IGTD 

Japan, Chiyoda 

624421583

Clinical Affairs Senior Manager (IGTD)

Your role:

Exciting opportunity to lead the team working on Cardiac and Endovascular registration projects for Philips Image-guided Therapy, which includes novel technologies integrated by therapeutic devices and visualization systems.

• Lead the Japan IGTD CA Team and all clinical studies and evidence development projects that the team is responsible for to proceed with the plan.
• Lead developing local clinical evidence development strategy and strategic discussion with the local RA team and other related stakeholders, including Business Unit, R&D, and Market Access & Reimbursement to accelerate projects and fast serve patients.
• Proactively identify risks within clinical evaluation strategies, plans, products and propose alternate approaches.
• Provide interpretation of local regulations to BU partners and ensure necessary requirements are fully deployed.
• Stay informed of new regulations and technologies relevant to endovascular therapeutics.
• Plan and execute clinical evidence development, GCP compliance review of foreign operated clinical trials, and PMS study as a condition of approval according to the regulations and aligned with local business needs.
• Manage interactions with MHLW/PMDA/KTLs and maintain a productive working relationship.
• Manage CRO services to ensure meeting with Philips’ business needs and operational policies.
• Review and approve clinical documentation according to the GCP/GPSP requirements.
• Oversee clinical administration activities.
• Report to the Head of Japan RA/CA as a solid line and the head of IGTD CA/MA as a dotted line.

You're the right fit if:

1. Experience.

• +10 years’ experience in clinical operation including medical device.
• Experience in the Study Manager role in medical device clinical studies and GCP compliance inspections by PMDA.
• Maintains extensive knowledge of the PMD act, GCP ordinance, GPSP ordinance, ICH guidelines, and ISO13485.
• Experience or working knowledge of EVT or any cardiovascular therapeutic medical devices.
• + 3 years' experience in people management.

2. Skills.

• Self-motivated and able to prioritize handling multiple tasks/responsibilities.
• Capable of thinking critically, logically, and strategically
• Bachelor of Science Degree (Master preferred)
• Fluent in Japanese and English

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