- Gaithersburg, Maryland, United States
- Senior
- $203K–$305K per year
Senior scientific leader responsible for safety science strategy, pharmacovigilance, risk management, and AI-enabled safety workflows for cell therapy assets.
Compensation
The annual base pay for this position ranges from $203K to $305K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
Responsibilities
- Lead safety surveillance, signal detection, validation, evaluation and management for assigned cell therapy assets
- Set the safety science strategy for multiple, complex or high-priority assets and translate emerging data into clear recommendations
- Lead proactive pharmacovigilance and risk-management planning, including Global Risk Management Plans, REMS, risk-minimization measures and benefit-risk assessments
- Provide strategic leadership and oversight for aggregate reports and safety deliverables, including DSURs, PBRERs/PSURs, PADERs, RMPs, REMS and ad hoc analyses
- Lead safety content and strategy for protocols, Investigator Brochures, Reference Safety Information, informed consent forms, clinical study reports, Data Monitoring Committee materials and core data sheets
Requirements
- Bachelor’s degree in life sciences, pharmacy, nursing or a related discipline
- Advanced degree in immunology, autoimmune disease, pharmacology, epidemiology or a related discipline
- Nice to have: Advanced degree (MSc, PhD, PharmD)