Overview
In this role you contribute to benefit-risk and medical safety in immunology-focused development programs. You will work within a growing cross-functional team to shape safety strategies for new medicines addressing immune-mediated diseases. You’ll influence early development decisions with scientific insight and lead governance discussions at senior levels. This opportunity offers impact across clinical development, regulatory submissions, and strategy in a hybrid, international setting.
Responsibilities
- Develop and maintain benefit-risk assessments, safety monitoring and risk management approaches across clinical development
- Analyze diverse scientific and safety evidence to identify emerging risks and their impact on patients
- Prepare safety reports, regulatory responses, submission documents and decision materials
- Collaborate across scientific, medical and regulatory functions to translate evidence into practical decisions
- At senior levels, own benefit-risk strategy, lead governance discussions and coordinate cross-functional work
Key requirements
- Bachelor’s/Master’s degree in a relevant scientific discipline; MD/PhD desirable
- Experience in pharmaceutical clinical development, medical safety, benefit-risk assessment, safety writing and risk management
- Experience in immunology, CAR-T cell therapy or T-cell engager development (advantage)
- Ability to analyze scientific evidence and communicate balanced conclusions in English
- Experience contributing to safety outputs with potential for strategic ownership and leadership in larger programs
- Comfort working across functions and lifecycle stages while maintaining quality and patient focus
- Interest in roles based in Belgium or United Kingdom hubs and willingness to work in an international environment
- cross-functional collaboration
- clear and balanced scientific communication
- leadership and strategic thinking
- benefit-risk assessment
- safety writing and regulatory submission preparation
- risk management
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