Clinical Development Lead Freelancer (mfd)

Lets 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 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.

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 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.

Our combined strength in pharmaceuticals and diagnostics offers you a unique opportunity to create innovative solutions that transform patient care. At Roche we aim high to deliver life-changing healthcare solutions.

If youre ready to make a meaningful impact on patients and healthcare systems worldwide this is the place for you!

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.