Clinical Development Lead – Diabetes Technology & Digital Health (m/f/d)

6935 mySugr GmbH; Wien; On-site; EUR 120,000 - 170,000; Full time

Job summary

Roche Vienna seeks a Clinical Development Lead with specialized diabetology expertise to provide strategic medical leadership across product design, regulatory clearance, and lifecycle management for the Roche Diabetes portfolio. You will guide CGM sensors, predictive algorithms, and SaMD development, shaping clinical claims and regulatory submissions.

The role requires crafting clinical evaluations, managing medical inputs, and collaborating with R&D, regulatory, and clinical teams to ensure

Qualifications

• Medical degree (MD) or relevant PhD; clinical training in endocrinology/diabetology preferred.
• Experience in medical device or SaMD design controls and clinical evaluation documentation.
• Strong English writing and communication; capable of interfacing with global health authorities.

Responsibilities

• Define intended use, indications, and clinical claims for Roche diabetes devices.
• Lead clinical evaluation plans and reports under EU MDR and FDA pathways.
• Provide medical input into design reviews, safety, and risk management.
• Collaborate with R&D, product management, and regulatory teams across the development lifecycle.

Skills

Clinical leadership

MD/PhD

Diabetes expertise

Regulatory knowledge

Medical writing

Fluent English

SaMD development

Regulatory strategies

Education

MD or equivalent

PhD in a related field

Job description

Let’s build a healthier future, together! By combining our unique strengths, we are redefining healthcare through sustainable action and innovation. For a behind-the-scenes look, check out this video to see how we at Roche are making personalized health care a reality. 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: Serving as a Clinical Development Lead with specialized expertise in diabetology, your primary role is to provide strategic medical leadership throughout the product design, definition, and regulatory clearance lifecycle for the Roche Diabetes portfolio. You will act as the clinical authority guiding continuous glucose monitoring (CGM) sensors, predictive algorithms, and connected digital health solutions (Software as a Medical Device - SaMD) development. Core responsibilities center on defining intended use and indications, architecting clinical claims, translating medical unmet needs into design inputs, and authoring rigorous clinical evaluation documentation to secure regulatory approvals across the FDA and EU MDR landscapes. Postmarket medical complaint assessments round out your holistic, lifecycle responsibilities.

Key Responsibilities:

Working within the Clinical Development and Medical Affairs organization at Roche, you will contribute to the following concepts:

• Intended Use & Clinical Indication Definition: Formulate and refine the Intended Purpose, Indications for Use (IFU), target patient populations, clinical environments, contraindications for next-generation CGM hardware and mobile software applications.
• Clinical Claims Architecture: Contribute to the end-to-end clinical claim matrix for product launches and iterative software releases. Align commercial, regulatory, and scientific objectives to define competitive, compliant claims around sensor accuracy, glycemic variability, predictive alerts, and user outcomes (collaborating with Clinical Operations on study concepts when de novo data generation is required).
• Medical Input into Design & Development: Partner closely with R&D, systems engineering, and product management from early concept through design freeze. Translate endocrinology realities into formal User Needs and Design Inputs, actively participating in design reviews and determining clinical benefit-risk trade-offs.
• Algorithm & Physiological Validation: Serve as the clinical partner to data science and algorithm development teams. Provide medical rationale for glycemic thresholds, trend arrow heuristics, sensor calibration logic, predictive hypoglycemia/hyperglycemia alerts, and automated insulin delivery (AID) interoperability parameters.
• Human Factors & Usability Clinical Support: Provide medical expertise into usability engineering and human factors testing protocols, ensuring user interfaces, alert schemes, and onboarding workflows are safe, intuitive, and clinically sound for both laypersons and healthcare providers.
• Regulatory Dossiers & Clinical Evaluations (FDA & EU MDR): Own the clinical evaluation process under EU MDR (2017/745) and FDA pathways (Pre-Submissions, 510(k), De Novo, PMA). Author, update, and defend Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), and Post Market Clinical Follow-Up Plans and Reports.
• Health Authority & Notified Body Interaction: Serve as the medical expert in regulatory interactions, directly defending the clinical validity of the device design, the clinical benefit-risk profile, and state-of-the-art determinations during Notified Body reviews and FDA meetings.
• Risk Management Collaboration and Medical Safety: Work closely with Risk Management to score probabilities of occurrence of harm and severities of harm for software and hardware devices (ISO 14971) and serve as the medical safety lead in assessing postmarket signals.

Key Qualifications & Core Competencies:

• Education & Credentials: Medical degree (MD or equivalent) or a relevant PhD is strongly preferred. Clinical training or extensive experience in Endocrinology, Diabetology, or Internal Medicine with a clear focus on diabetes management technologies is preferred.
• Medical Device Development Expertise: Proven track record supporting medical device or SaMD design controls. Demonstrated experience authoring Intended Use statements, establishing clinical claim structures, and providing medical inputs into design specifications.
• Diabetes Tech & Digital Health Acumen: Deep functional understanding of continuous glucose monitoring (CGM) systems, electrochemical sensor characteristics, data analytics, algorithmic alerting logic, and digital health architectures.
• Global Regulatory Frameworks: Advanced knowledge of EU MDR (2017/745) requirements for clinical evaluation (MEDDEV 2.7/1 rev 4, MDCG guidance) and FDA regulatory mechanisms for diabetes devices and digital health (interoperable CGM/iCGM, automated insulin dosing, clinical decision support software).
• Benefit-Risk Assessment & Standards: Working familiarity with ISO 14971 (Application of risk management to medical devices) and usability standards (IEC 62366), specifically from a clinical hazard and benefit-risk balance perspective.
• Communication & Influence: Exceptional medical writing and scientific communication skills, with proven capability to defend clinical rationale before global health authorities and internal governance bodies.
• Fluent in written and spoken English.

Our Team

Our team is defined by independence and diversity, encompassing a wide range of educational backgrounds and professional experience levels. We place a high value on team spirit, collaboration, and ensuring that our highly impactful work remains engaging and enjoyable.

Who You Are

You are an independent, conscientious professional and a dedicated team player with a strong commitment to quality. You bring an interdisciplinary mindset, adaptability, and the confidence to make critical decisions. You build alignment across functions with differing priorities and inspire a positive and collaborative spirit.

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 world’s 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 people’s needs, strong data and clinical insights. Healthcare that saves lives.

Roche is an Equal Opportunity Employer.

We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.