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Philips Clinical Affairs Senior Manager IGTD 
Japan, Chiyoda 
624421583

24.06.2024
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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