Clinical Development Lead - Freelancer (m/f/d)

F. Hoffmann-La Roche AG; Wien; Vor Ort; EUR 120.000 - 180.000; Vollzeit

Zusammenfassung

Roche Diagnostics Solutions (RDS) in Vienna is seeking a Clinical Development Lead for Cardiovascular and Metabolic diseases to shape clinical strategy and lead large-scale development programs. In this senior role you will partner with Regulatory Affairs, KOLs and cross‑functional teams to design studies, manage global submissions, and drive evidence generation for new diagnostics.

The ideal candidate holds an MD or PhD in a related field, with proven leadership in IVD/Medical Device trials and

Qualifikationen

• Medical degree (MD) or an advanced degree (PhD) in cardiology, metabolic diseases, obesity or related fields.
• Established experience within academia, diagnostics, or the pharmaceutical industry, in the CVMD area.
• Clinical Expertise: Proven track record in IVD or Medical Device study management across all stages of global clinical trials, including protocol design and report writing.
• Program Leadership: Demonstrated experience leading large, complex development programs and guiding cross-functional, matrixed teams.
• Regulatory Knowledge: Deep understanding of applicable global standards and regulations, such as ICH-GCP, IVDD/IVDR, MDR, FDA, and NMPA.
• Inclusion & Collaboration: Ability to partner effectively across diverse regions, cultures, and time zones to foster an environment of belonging and collaboration.

Aufgaben

• Drive Clinical Strategy: Lead the clinical development strategy for large-scale studies and complex programs, in the CVMD area, defining clinical utility, intended use, and claim extensions across our portfolio.
• Lead Health Authority Interactions: Work closely with Global Regulatory Affairs in the completion and submission of global regulatory filings, authoring critical sections of meeting packages and reviewing clinical documents for international regulatory submissions.
• Forge Stakeholder Partnerships: Act as the medical lead in external interactions with health authorities, build strategic relationships with international Key Opinion Leaders (KOLs), and drive development partnerships across industry and academia.
• Foster Communication Excellence: Oversee the implementation of communication strategies for clinical studies, representing the organisation at major medical congresses, advisory boards, and in key publications.
• Champion Innovation & Excellence: Act as a key driver for competitive differentiation, innovation, and early pipeline activities while developing intellectual property strategies and optimising clinical processes.
• Coach and Mentor: Act as a dedicated coach for team members, nurturing confidence and helping colleagues develop their skills and expertise.

Kenntnisse

Analytical thinking

Strategic thinking

Cross-functional collaboration

Program leadership

Regulatory knowledge

Ausbildung

MD or PhD in cardiology/metabolic diseases/obesity or related fields

Jobbeschreibung

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:

At Roche Diagnostics Solutions (RDS), our mission is clear: to diagnose earlier, develop faster, and personalise treatment because every patient is unique.

Our Clinical Development & Medical Affairs (CDMA) team drives innovation to improve healthcare outcomes globally. We see ourselves and our customers as a team that can only reach its full potential together. By listening closely to patients and physicians, and leveraging digitalisation and new technologies, we get closer to their real-world needs. This collaborative spirit creates an environment where ideas can grow and new ways of doing things can be tried - resulting in competitive products that get to patients faster.

Our work spans the entire product lifecycle, from discovery to post-launch. By collaborating with internal teams, external partners, and patients, the CDMA chapter provides crucial medical insights, designs and executes clinical studies, and offers on-market support. Ultimately, we generate the comprehensive clinical evidence that demonstrates product safety, effectiveness, and scientific validity - facilitating smooth product registration, adoption and reimbursement globally so we can save lives and improve patient quality of life.

Your upcoming mission Are you ready to shape the future of healthcare by leading the clinical development strategy for next-generation diagnostic solutions? As a Clinical Development Lead, Cardiovascular and metabolic diseases (CVMD) within our Clinical and Medical Affairs organisation in Diagnostics, you will play a pivotal role in planning and implementing clinical development activities that bring medically-differentiated solutions to patients globally. In this role, you will act as a senior strategic voice and trusted advisor, fostering an environment where science and collaboration thrive.

Key Responsibilities:

• Drive Clinical Strategy: Lead the clinical development strategy for large-scale studies and complex programs, in the CVMD area, defining clinical utility, intended use, and claim extensions across our portfolio.
• Lead Health Authority Interactions: Work closely with Global Regulatory Affairs in the completion and submission of global regulatory filings, authoring critical sections of meeting packages and reviewing clinical documents for international regulatory submissions.
• Forge Stakeholder Partnerships: Act as the medical lead in external interactions with health authorities, build strategic relationships with international Key Opinion Leaders (KOLs), and drive development partnerships across industry and academia.
• Foster Communication Excellence: Oversee the implementation of communication strategies for clinical studies, representing the organisation at major medical congresses, advisory boards, and in key publications.
• Champion Innovation & Excellence: Act as a key driver for competitive differentiation, innovation, and early pipeline activities while developing intellectual property strategies and optimising clinical processes.
• Coach and Mentor: Act as a dedicated coach for team members, nurturing confidence and helping colleagues develop their skills and expertise.

Who You Are

You are an analytical, strategic thinker who thrives in a fast-paced, matrixed environment. You are passionate about customer and patient-centricity, and you excel at integrating multiple cross-functional perspectives into a unified clinical strategy.

Qualifications & Experience

Medical degree (MD) or an advanced degree (PhD) in cardiology, metabolic diseases, obesity or related fields.

Established experience within academia, diagnostics, or the pharmaceutical industry, in the CVMD area.

Clinical Expertise: Proven track record in In Vitro Diagnostics (IVD) or Medical Device study management across all stages of global clinical trials, including protocol design and report writing.

Program Leadership: Demonstrated experience leading large, complex development programs and guiding cross-functional, matrixed teams.

Regulatory Knowledge: Deep understanding of applicable global standards and regulations, such as ICH-GCP, IVDD/IVDR, MDR, FDA, and NMPA.

Inclusion & Collaboration: Ability to partner effectively across diverse regions, cultures, and time zones to foster an environment of belonging and collaboration.

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.

Interested? Great.

We’d like to hear from you!

Roche is an Equal Opportunity Employer.

mySugr is an agile organization that aims to attract creative problem-solvers who want to have a positive impact on healthcare. We provide a safe and fun environment where employees are encouraged to be evaluative, constructive, and candid. We look for confident individuals that are ready to shape their journey with us.