Overview In this role you will lead the Global Patient Safety Sciences Delivery for General Medicine, ensuring compliant execution of safety surveillance, signal management, and aggregate reporting. You will build and grow a high-performing team, standardize core safety processes, and collaborate across regulatory, clinical, and strategy functions to drive patient safety outcomes. You will shape safety deliverables for periodic reports and scientific documents while enabling innovation and the use of new technologies. This is a mission-driven opportunity at a fast-growing, science-focused biotech leader.
Compensation / Benefits- annual bonuses or incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- paid time off
Responsibilities- Lead and develop Safety Scientists, build a high-performing team and succession plans
- Drive standardization and consistency in core safety activities (signal detection, safety document authoring) across products and therapeutic areas
- Ensure compliant execution of Safety Sciences Delivery activities with SOPs and monitoring tools
- Coordinate all aspects of signal detection and management (SMT, SSP, SER) for General Medicine
- Analyze aggregate safety data to identify emerging issues in partnership with Safety Sciences Strategy
- Support high-quality, timely benefit-risk assessments for DSURs/PSURs and contribute to GPS portfolio safety documents (ARM, RMP, SMP)
- Develop and implement training programs, maintain a standardized safety curriculum and knowledge repository
- Liaise with Safety Sciences Strategy General Medicine GPS Leads and cross-functional partners (Clinical, Regulatory, Med Affairs, Biostats & Data Management)
- Drive talent strategy, leadership development, and workforce planning across Strategy and Delivery
- Lead cross-functional coordination to improve safety operations and expand use of new technologies
- Champion on-site collaboration and adherence to regulatory standards across global operations
Key requirements- Advanced Degree required in life sciences or healthcare with 12+ years of PV experience
- Strong attention to detail and ability to enhance safety operations processes for quality and compliance
- Proven leadership, interpersonal, verbal and written communication skills; ability to manage multiple projects
- Preferred: experience overseeing operations within global patient safety and matrixed orgs; familiarity with AI technologies; people management experience
- leadership
- interpersonal communication
- written communication
- signal detection coordination and management
- safety surveillance and aggregate reporting
- DSURs and PSURs preparation
