Associate Director Medical Affairs Top Global IVD Company Global Role

4 days ago

Budapest, Budapest, Hungary Carbyne Full time 120,000 - 240,000 per year
On behalf of our client, a top global IVD company, we are searching for a Physician to join their global clinical affairs team. The Associate Clinical Affairs Medical Director will serve key roles to provide leadership on medical, scientific, and clinical decisions to meet growing need for medical expertise in supporting new product development and legacy product risk/benefit analysis, clinical study development/execution, clinical health hazard evalutation (HHE) for product field action/recalls, post-marketing clinical performance and clinical evidence IVDR requirements.

Responsibilities:
  • Collaborate cross-functionally to collect, evaluate, and communicate key clinical, medical, and scientific data.
  • Support clinical and regulatory strategy, legacy product risk/benefit analysis, and clinical study development/execution.
  • Evaluate clinical health hazards for product field actions/recalls and address post-marketing clinical performance and evidence requirements.
  • Provide medical insights for design specifications and regulatory submissions, engaging with regulators like the FDA.
  • Offer expertise in device risk analyses, health hazard evaluations, adverse event reviews, and risk/benefit reporting.
  • Lead the design and implementation of clinical trials to establish robust evidence for product efficacy and safety.
  • Work closely with clinical study site physicians to ensure patient safety and protocol compliance.
  • Develop and implement clinical trial strategies across the company's IVD product portfolio.
  • Cultivate collaborative relationships with medical institutions and professional associations.
  • Enhance standardization, clinical evidence generation, and support appropriate product adoption and use.
Requirements:
  • MD degree
  • 2 years minimum experience as medical advisor in diagnostics, medical device, biopharma, clinical labotory or related industry with role defined in above job responsibility.
  • Experience in developing and maintaining expert knowledge for the company's product covered disease area, and medical research in general.
  • Proven track record of successful collaboration with key opinion leaders, for example, planning medical advisory boards, managing relationship with external experts and interactions with regulatory agencies during presubmission and submission review.
  • Ability to manage multiple complex projects with defined timelines.
  • Strong leadership, excellent written and verbal English communication skills required for report preparation and negotiation with internal and external parties.
  • A good communicator facing public with capability to present in professional conferences.
  • Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
 Should you be interested in the details of this vacancy please submit your CV.

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