RayzeBio Safety MD Senior Director
$306.81k - $371.79kBristol Myers Squibb
RayzeBio seeks a Safety MD Senior Director to lead medical safety and pharmacovigilance for radiopharmaceutical oncology programs. The role encompasses clinical safety oversight, regulatory compliance, risk management, and cross-functional collaboration across development and post-marketing activities.
Responsibilities
- Lead global pharmacovigilance strategy, signal detection, and FDA/EMA regulatory compliance
- Establish safety governance structures, SOPs, and continuous improvement processes
- Direct safety evaluation and benefit-risk assessments for clinical and post-marketing products
- Represent Safety Science in regulatory submissions, health authority interactions, and inspections
- Mentor cross-functional colleagues and direct reports on pharmacovigilance practices
Requirements
- MD or equivalent medical degree
- 10+ years pharmacovigilance, safety science, or pharmaceutical industry experience
- Knowledge of FDA, EMA, and ICH global pharmacovigilance regulations
- Expertise in signal detection, risk management, and benefit-risk assessment
- Experience interacting with regulatory authorities and scientific advisory bodies
- Strong leadership and cross-functional collaboration skills
Compensation: $306,814 - $371,787 base
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