Medical Director – Safety
Nestle
full-time
Posted on:
Location Type: Office
Location: Lausanne • Switzerland
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Job Level
About the role
- Provide expert safety leadership and input to clinical development programs for nutritional solutions and therapeutics across the lifespan.
- Ensure safety compliance with regulatory frameworks applicable to pharma, medical nutrition and food for medical purposes (FSMP).
- Responsible for building safety assessments and safety management plans optimized for trial design.
- Conduct signal detection, monitoring, evaluation, interpretation and appropriate management & reporting of safety information such as annual safety reports, based on data from all relevant sources.
- Lead safety input to Data Safety Monitoring Boards charters, aggregate safety reports (DSUR/ASR where applicable), and risk management plans; contribute to Safety & Risk Management Team (SRMT) and signal review forums.
- Coordinate the management of internal trial safety boards and committees.
- Drive safety strategies and ensure safety compliance with applicable regulatory frameworks, in close collaboration with clinical development, data management, medical, scientific and regulatory affairs teams as well as trusted external providers for case processing.
- Engage with key opinion leaders (KOLs) and investigators, to shape safety strategies, including those informed by independent safety data monitoring committees, and to optimize alignment with clinical trial designs.
- Respond to inquiries regarding safety issues and collaborate closely with regulatory teams for health authority responses for nutritional solutions.
- Support a core team working on end-to-end pharmacovigilance for nutrition therapeutics with signal evaluation and risk management.
Requirements
- Medical degree, MD/PhD, preferably with specialization in one of the following areas: internal medicine / gastroenterology / pediatrics / clinical pharmacology.
- Swiss medical practice license is a plus
- At least 5 years’ experience in clinical research and safety, in development or operations (pharma, biotech, diagnostics, medtech, nutrition, or CRO settings)
- Experience and proven impact in leading safety management in complex clinical trials, including issue management and regulatory frameworks of nutrition and medical nutrition
- Expertise in preparation of clinical safety assessments and regulatory submissions involving safety information
- Strong strategic acumen with experience in collaborating across matrixed, cross-functional teams
- Ability to analyze, interpret, and communicate complex clinical and scientific information
- Effective external engagement capabilities (KOLs, agencies, investigators, safety vendors)
- Ability to balance urgency, quality, and compliance in dynamic development environments.
Benefits
- Exciting opportunities to develop your career your way
- Flexible working arrangements - facilitating creativity and collaboration.
- A culture of respect, with diversity, equity and inclusion at its core.
- A dynamic international environment empowering you to learn, develop and grow.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
safety assessmentssafety management planssignal detectionsafety information reportingrisk management plansclinical safety assessmentsregulatory submissionspharmacovigilanceclinical trial designissue management
Soft Skills
strategic acumencollaborationcommunicationexternal engagementanalytical skillsinterpretation of complex informationleadershipproblem-solvingadaptabilityquality management
Certifications
MDPhDSwiss medical practice license