Associate Director Clinical Medical Affairs

Associate Director Clinical Medical Affairs

Bio-Rad

Budapest, Hungary

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 evaluation (HHE) for product field action/recalls, post-marketing clinical performance and clinical evidence IVDR requirements.

How You will make an impact:

• Partner cross-functionally to collect, evaluate, and communicate key clinical, medical and scientific data to support clinical and regulatory strategy, legacy product risk/benefit analysis, clinical study development/execution, clinical health hazard evaluation (HHE) for product field action/recalls, post-marketing clinical performance and clinical evidence IVDR requirements across all business areas and across the product lifecycle;
• Provide medical insight to the development of design specifications; medical expertise to regulatory submissions; participation in external meetings where medical expertise is required with regulators (e.g. FDA);
• Provide medical expertise input to device risk analyses, preparation of health hazard evaluations (HHE), adverse event review, and risk/benefit reporting;
• Provide leadership in designing and implementing clinical trials to generate robust clinical evidence supporting the efficacy and safety of IVD products. Closely work with clinical study sites physicians to ensure patient safety and study site compliance to study protocol;
• Develop and implement clinical trial strategies for Bio-Rad IVD product portfolio actively participating providing input based on clinical value and strong medical understanding of physician and patient needs;
• Develop collaborative relationships with medical scientific institutions and participate in professional associations to enhance standardization, clinical evidence generation and support product adoption and appropriate use;
• Creating and implementing global clinical medical affairs strategy in support of a broad portfolio and pipeline of innovative in vitro diagnostic products;
• Providing medical expertise driving operational excellence in support of Bio-Rad commitment to quality and patient healthcare in product risk evaluation, risk/benefit analysis, Adverse Events/Serious Adverse Events and complaint review;
• Supporting global regulatory pre-submission and submission strategy and execution interfacing with regulatory agencies, as needed, to provide medical input related to use of Bio-Rad in-vitro diagnostic tests to support intended use including use for patient treatment or diagnosis;
• Providing medical expertise to support clinical study development and execution in the US and Europe.

What You’ll bring:

• MD degree and licensed as a physician with the American Board of: Internal Medicine, Infectious Disease, Immunology, Obstetrics and Gynecology, Family Medicine, or the European equivalent;
• 2 years minimum experience as medical advisor in diagnostics, medical device, biopharma, clinical laboratory or related industry with role defined in above job responsibility;
• Experience in developing and maintaining expert knowledge for Bio-Rad 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 pre-submission 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.

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