Position Summary
As a Medical Director for Clinical Trial/Research Safety you will provide expert safety leadership and input to clinical development programs for nutritional solutions and therapeutics across the lifespan, and ensure safety compliance with regulatory frameworks applicable to pharma, medical nutrition and food for medical purposes (FSMP).
A Day in the Life of a Medical Director Safety
* 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.
* This position will have functional/dotted line alignment to internal patient safety & risk management governance frameworks.
What Will Make You Successful
* Medical degree, MD/PhD, preferably with specialization in internal medicine, gastroenterology, pediatrics, or 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.
Nestlé is committed to the accessibility of its recruitment process. If you require an adaptation during the recruitment process, please do let us know so we can support you effectively. All information will be treated confidentially.
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