Senior Clinical Evaluation Manager (mfd)

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The mySugr GmbH was acquired by Roche in 2017 and our Vienna office is one of Roches 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.

Heres what were 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:

• A Medical Degree (MD) is strongly preferred; PhDs with significant experience in clinical evaluations are a plus!

• 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 pharmaceutical medical device or biotechnology industry (e.g. Clinical Evaluator for medical devices).

• Solid understanding of the Diabetes and its technical and medical state-of-the-art.

• Solid understanding of the CGM business and its technical and medical state-of-the-art.

• Demonstrated experience in developing and managing relationships with teams and experts in the Diabetes or related space.

• Strong understanding of clinical trial design data analysis and pharmacovigilance/device safety.

• Experience with clinical trial safety oversight as a Study Safety Officer is a significant asset.

• Strategic mindset with the ability to translate complex scientific and technical concepts into actionable plans.

• Excellent communication presentation and interpersonal skills.

• A true team player is a must.

• Fluency in English is required. Proficiency in German is highly advantageous.
  

In Austria we have a legal obligation to disclose the minimum salary according to our collective agreement which is gross EUR 3.843 - per month for this position. But! Rest assured we offer amazing competitive compensation packages which take into consideration current market trends therefore you can expect a higher offer that reflects your experience level.

Who we are and what we care about

We are committed to providing a healthy equal and inclusive working environment for our employees to bring true relief to the patient! We care about family friendly career paths sustainability a healthy lifestyle and the flexibility of a modern workplace. We maintain a culture of learning and sharing as well as open and candid feedback. At every level there are many opportunities to develop and grow - both professionally and personally.

As a healthcare pioneer committed to transforming the lives of billions of people around the globe we push boundaries to redefine what is possible. We know that early accurate diagnosis is essential to maintain health prevent disease and help advance new targeted treatments and potential cures for the worlds most serious health problems. We have a passion for innovation and a profound commitment to make a lasting impact on society by continuing to improve the standard of care for humankind. Our culture inspires us to create healthcare that is sustainable efficient and financially viable. Healthcare that is built on peoples needs strong data and clinical insights. Healthcare that saves lives.

Interested Great. Wed like to hear from you! Just click that Apply Now button and send us your CV in English . and anything else that you think might impress us.

Roche is an Equal Opportunity Employer.