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Meet the team

At 1MED, our team is united by a shared commitment: improving patient outcomes.
Combining scientific expertise, practical experience, and innovative thinking, we develop solutions that support better decisions across the development journey.
Together, we bring the knowledge and dedication that our partners rely on.

Advancing science, together

Founder

Enrico Perfler

Founder

Executive team

Janet Kube

Chief Executive Officer

Tim Ampstead

Chief Financial Officer

John Thomas

Vice President of Clinical
Operations and Strategic Delivery

Extended leadership team

Alessandro
Malaspina

Head of Regulatory Affairs

Ivano
Oliveri

Head of Quality Assurance

Azzurra
Grande

Human Resources Manager

Giorgia
Bigioni

Head of Start-Up & Clinical
Operations Unit - Switzerland

Flavia
Baruzzi

Scientific Director

Anne-Claire
Thieulin

Head of Clinical Operations/ Site Head - France

Alberto
Santinon

IT Manager

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Enrico Perfler

Founder

Enrico Perfler is the founder of 1MED, bringing over 20 years of experience in the medical device industry with deep expertise in regulatory affairs and medical device technology. Since establishing the company in 2014, he has led 1MED in delivering regulatory support, digital solutions, and full-service CRO capabilities to clients in the MedTech and pharmaceutical sectors, with a strong focus on in vitro diagnostics and medical devices.

Under Enrico’s leadership, 1MED has supported the development and regulatory approval of more than 500 medical devices in Europe, positioning the company among the top outsourcing partners in the life sciences industry. He also shares his expertise as a contract professor of Regulatory Affairs at the University of Pavia and contributes to international standardization efforts as a member of the ISO/TC 194 technical committee for the biological evaluation of medical devices.

Janet Kube

Chief Executive Officer

Bringing over 25 years of experience, Janet Kube is a visionary leader with a strong focus on harmonizing processes, uniting teams and fostering an environment where people can strive, grow, and succeed together. She leads with empathy and purpose, without losing sight of how closely connected we all are to the lives we aim to improve.

Her extensive experience has given her a hands-on understanding of what it takes to guide clinical trials with a human-centric perspective, building strong connections between regulatory frameworks, patient safety, and data integrity.

This blend of strategic vision and human-centered leadership enables 1MED to strengthen its role as a trusted partner in healthcare development and innovation, while nurturing a culture of collaboration and excellence across the organization.

Tim Ampstead

Chief Financial Officer

With over 25 years of senior financial leadership experience, Tim Ampstead is a results-driven CFO focused on building strong financial foundations and enabling organizations to scale with confidence. He brings a pragmatic, hands-on approach, ensuring finance acts as both a control function and a driver of sustainable growth. Across private-equity-backed and mid-to-global businesses, Tim has led restructurings, optimized capital structures, and executed acquisitions, working closely with boards and investors to strengthen governance, performance visibility, and disciplined decision-making. This combination of financial strategy, operational rigor, and investor alignment positions the business to grow efficiently, integrate acquisitions successfully, and deliver long-term value.

John Thomas

Vice President of Clinical Operations and Strategic Delivery

Based in the UK, John Thomas brings over 20 years of leadership experience in clinical research across the MedTech, Biotech, and pharmaceutical sectors. He has led complex, multi-national programmes spanning pre-market pivotal trials, post-market clinical follow-up, and real-world evidence initiatives across a broad range of therapeutic areas. John partners closely with sponsors at both operational and executive levels, providing strategic governance, risk oversight, and delivery leadership to ensure programmes remain inspection-ready, efficient, and aligned with evolving regulatory expectations.
As a senior member of the 1MED leadership team, he plays a key role in strengthening organisational capability, optimising delivery models, and enabling scalable, patient-centred solutions that meet both clinical and commercial objectives. He is a trusted partner to sponsors, valued for providing clear strategic direction, practical solutions, and dependable execution across complex, multi-country clinical programmes.

Alessandro Malaspina

Head of Regulatory Affairs

With nearly 15 years of specialized experience in medical device technology and regulatory consulting, Alessandro has guided clients through the full lifecycle of their medical devices, from developing tailored regulatory strategies to navigating complex compliance challenges with confidence. He combines technical expertise with a practical, problem-solving approach, implementing MDR-compliant Quality Management Systems and achieving successful medical device registrations in both EU and international markets.

Alessandro’s focus is always on patient safety and addressing every need of the client to achieve the best possible outcomes. He leads his department with genuine dedication, valuing the contributions of every team member. The environment he has fostered, with both his team and clients, allows him to remain actively present throughout every step of their journey.

Ivano Oliveri

Head of Quality Assurance

Ivano Oliveri leads Quality Assurance at 1MED, bringing extensive expertise in strategic, regulatory, clinical, and quality development for both medical devices and in vitro diagnostics. Since 2008, he has supported MedTech companies in building robust quality systems and navigating the evolving regulatory landscape with confidence.

Ivano holds a Degree in Biomedical Engineering from the University of Genoa and serves as a contract lecturer at the University of Pavia for the course “Regulatory Affairs in the Design, Development and Certification of Medical Devices.” He is also a tutor for MDR, IVDR, ISO 14971, and ISO 13485 with a leading international Notified Body, sharing his deep knowledge to strengthen industry standards and practices.

Azzurra Grande

Human Resources Manager

With a decade of experience in Human Resources, she believes that people don’t just sit at the center of an organization, they are the organization.

What drives her every day is the conviction that when people feel seen, heard, and genuinely supported, something powerful happens: trust is built, connections grow, and collaboration becomes real. From that space of human closeness, not only do teams thrive, entire organizations begin to breathe, evolve, and move with purpose.

For her, every exchange, even the smallest one, is a chance to build something — understanding, connection, possibility.

With her background in Social Work and HR, she ensures 1MED’s people-first approach is lived, not just stated.

Giorgia Bigioni

Head of Start-Up & Clinical Operations Unit - Switzerland

Giorgia Bigioni leads the Start-Up & Clinical Operations Unit at 1MED, bringing over 10 years of experience across healthcare products, nutraceuticals, and cosmetics. She combines her strong background in business administration and clinical operations to support clients in successfully launching and managing complex clinical studies.

Giorgia holds an International Master’s Degree in Phytotherapy from the University of Cagliari, Italy, and a second Master’s Degree in Management of Biomedical and Biotechnological Companies from the University of Sacro Cuore, Italy. Her career began at Abbott and AbbVie, followed by key roles at IQVIA, before joining 1MED, where she has driven clinical operations excellence for the past six years.

Flavia Baruzzi

Scientific Director

With a degree in Chemistry and Pharmaceutical Technology, Flavia brings over thirty years of experience in clinical research, managing clinical trials involving drugs, medical devices, and food supplements across a wide range of therapeutic areas. Her career includes roles of increasing responsibility, Clinical Monitor, Project Manager, Group Project Manager and Team Leader.

In 2007, she co-founded LB Research Srl, part of 1MED , where she served as Scientific Director, role she continues to hold, supporting the company’s scientific strategy and contributing to its ongoing growth and development.

Anne-Claire Thieulin

Head of Clinical Operations/ Site Head - France

Anne-Claire is a seasoned clinical research professional with over 15 years in the field, currently serving as Head of Clinical Operations and Site Head at the 1MED French office. She holds advanced degrees in Biostatistics and Public Health and has a strong track record in managing clinical investigations from design to close-out, particularly in the medical device sector.
Her expertise spans project management, data management, medical writing, and regulatory compliance under ISO 14155. Anne-Claire leads multidisciplinary teams and ensures high-quality delivery of clinical projects through structured coordination and a rigorous methodological approach.

Alberto Santinon

IT Manager

With over 10 years of experience in the IT sector, Alberto is an IT Manager focused on building secure, reliable, and scalable technology environments that support business performance and continuity. He combines a proactive, solutions-driven mindset with strong operational discipline to ensure systems consistently enable growth and resilience.

His expertise spans complex infrastructure management, cybersecurity, and data protection, alongside the adoption of cloud technologies and automation to improve efficiency and reliability.
By aligning IT strategy with business objectives, he helps drive digital transformation, strengthen security, and support sustainable growth.

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