Senior Medical Manager / Senior Clinical Evaluation Manager

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The mySugr GmbH was acquired by Roche in 2017 and our Vienna office is one of Roche's global sites. You will be located here, in the heart of Vienna, no matter if you work on a mySugr®, Accu-Chek®, navify® or any other Roche product or solution. You can read more about the history of mySugr & Roche here.

Here's what we're looking for:

We are seeking a dedicated and expert Medical Doctor with academic experience to join our team as a Senior Medical Solutions Manager / Senior Clinical Evaluation Manager, focusing on our cutting-edge Diabetes Care and Diagnostics portfolio. You bring strong experince with clincial evaluations and can serve as a subject matter expert in the team.

This critical role serves as the medical and clinical authority for our diabetes-related devices, including Medical Device Software, Insulin Pumps and Continuous Glucose Monitoring (CGM) systems. You will be responsible for leading the clinical evaluation of our products, generating and appraising clinical data, and engaging with key stakeholders across the healthcare ecosystem. You will contribute to authoring Medical Risk Assessments for assays, a wide range of IVDs and laboratory products. Your expertise will directly influence product strategy, ensure patient safety, and drive the adoption of our life-changing technologies.
 

Your upcoming mission:

• Data Generation & Clinical Support:

• Author and lead the clinical evaluation efforts for Diabetes Care devices, including pumps and CGMs, ensuring alignment with regulatory requirements.

• Provide expert medical input for critical safety and regulatory documents, including Clinical Evaluation Reports, Medical Risk Assessments (MRA), and Risk Enablers.

• Identify local data gaps and lead data generation activities; design and oversee Post-Market Clinical Follow-Up (PMCF) plans and studies.

• Serve as a Study Safety Officer for assigned clinical trials, ensuring the well-being of participants and the integrity of study data.

• Serve as MRA author for assays, IVDs and laboratory products.
   

• Stakeholder Engagement & Scientific Exchange:

• Develop and cultivate robust, long-term strategic relationships with internal colleagues, clinicians, research institutions, and other key external stakeholders in the diabetes field.

• Drive high-impact knowledge exchange and data communication to ensure the medical community is informed of the latest scientific advancements and clinical data for our devices.
   

• Cross-Functional Collaboration & Compliance:

• Provide deep medical expertise and collaborate closely with internal teams, including Clinical Operations, Regulatory Affairs, pre- and post-Market Quality, Market Access, and Commercial.

• Participate in and provide medical support for interactions with national Health Authorities and Notified Bodies.

• Ensure all medical activities are conducted with the highest ethical standards and in full compliance with all applicable laws, regulations (e.g., MDR), and company procedures.

Qualifications and Experience

• Education:

• A Medical Degree (MD) is strongly preferred; PhDs with significant experience in clinical evaluations are cordially invited to apply

• Experience & Skills:

• An extended skill set and academic or industry experience in Diabetes and/or a related field is required.

• Proven experience in a relevant role within the pharmace