Senior Medical Monitor

Research & Innovation at Danone

“Bringing health through food to as many people as possible.”

At Danone, this purpose is rooted in our heritage and guides everything we do—from developing science-based nutritional solutions to promoting sustainable practices that protect our planet. As a Société à Mission, we are committed to creating both economic and social value, with a focus on health, nature, and people & communities.

Joining Danone means becoming part of a collaborative and inclusive environment where your expertise makes a real impact. You will contribute to the development of innovative, science-based nutritional solutions, and bring an impact on shaping a healthier future for people and the planet.

As a Senior Medical Monitor, you will hold a pivotal role for safeguarding the safety and well-being of clinical study participants, as well as upholding the integrity of the studies. You will provide expert medical oversight, manage serious adverse events (SAEs), conduct safety signal detection, and contribute to the development of safe, evidence-based nutritional products aligned with Danone’s health-driven mission.

KEY RESPONSIBILITIES AND IMPACT AREAS:

• Medical oversight: provide expert medical supervision across multiple complex clinical studies.
• Scientific strategy execution: translate strategic roadmaps into actionable project contributions.
• Impact on business results: business impact by understanding the scientific strategic roadmaps and execute this strategy through efficient project contribution, ensuring timely and safe delivery of clinical studies to ensure evidence on our research and products.

• Managerial complexity: driving safety monitoring amongst different studies at the same time.

• Process ownership: lead and innovate safety evaluation processes by proactively identifying opportunities for improvement, staying current with evolving industry standards, and leading the implementation of new approaches. Ensuring alignment with senior stakeholders across functions.
• Serve as a mentor by training and influencing cross-functional teams on best practices in clinical safety.

KEY DELIVERABLES

• Oversee clinical studies activities and ensure compliance with protocols and regulatory standards.
• Serve as the primary medical contact for study teams, investigators, and other internal/external stakeholders.
• Contribute to protocol development, study design, and medical monitoring plans
• Safety assessment on reported safety event (adverse event)
• Evaluate and follow up on Serious Adverse Events (SAEs) in a timely and thorough manner, including determining causality and expectedness of SAEs, ensure regulatory compliance in reporting, and maintain comprehensive SAE documentation for all clinical study cases.

• Monitor safety trends and collaborate across functions to identify potential safety signals

• Escalate medical alerts and ensure proactive risk management.
• Reviews and approves essential clinical study documents (protocols, product information, safety reports, study reports) from a medical and safety perspective.
• Collaborate across internal cross-functional teams as a business partner and external stakeholders (investigators, KOLs, CROs) to ensure alignment and excellence in execution.
• Stay current with relevant legislation and industry developments.

About you

We are looking for a passionate and experienced physician who brings both clinical expertise and a forward-thinking mindset to the role. The ideal candidate will have:

• A Medical Doctor's (MD) degree
• A strong foundation in clinical practice and patient care

• Significant experience in international clinical research, particularly in the pharmaceutical, nutrition, or healthcare sectors.
• Experience in pharmacovigilance or nutrivigilance is a plus

• In-depth knowledge of ICH-GCP, clinical trial methodology, regulatory requirement, and safety monitoring practices.

• Proven ability to collaborate across multidisciplinary teams and influence stakeholders effectively.
• A mindset geared toward continuous learning, with the ability to adapt quickly and embrace technology and digital innovation in clinical research.
• Confidence in using digital tools and emerging technologies to enhance trial safety, efficiency, and impact.
• Excellent command of spoken and written English, with the ability to communicate complex clinical information clearly in study documents and presentations.

About Danone

Working at Danone is a unique experience. It’s fast-paced and complex, and at times, it can be challenging. But it’s packed with opportunities to learn and grow, working with some of the best-known brands in the world, like Evian, Alpro, Nutricia, Activia, and Nutrilon. Bring your unique perspective, ambitions, and entrepreneurial ideas to the table – the impact you could make might just surprise you.

We’re proud to be a B-Corp certified company. That means we meet the highest verified standards of social and environmental performance, transparency, and accountability in everything we do.

Onze visie 'One Planet. One Health.' legt de cruciale verbinding tussen het welzijn van de mens en de gezondheid van de planeet.