Director, Safety Scientist

Director, Safety Scientist

The Director, Safety Scientist serves as a key leader within Global Patient Safety, providing strategic oversight and scientific leadership for the evaluation and management of safety risks across the portfolio through:

• Leading the scientific evaluation and management of safety risks across assigned programs, with accountability for high-quality, evidence-based outputs
• Driving proactive, data-informed safety strategies in close partnership with GPS Medical Directors and cross-functional stakeholders
• Ensuring robust, timely, and aligned benefit–risk assessments throughout the product lifecycle
• Overseeing delivery of safety science activities, ensuring consistency, quality, and adherence to timelines
• Shaping safety strategy and recommendations that inform governance discussions and key decision-making forums
• Leading, coaching, and developing a team of Safety Scientists, fostering scientific rigor, accountability, and continuous improvement
• Promoting consistency in scientific approach and execution across programs and team members
• Collaborating effectively across clinical, regulatory, and other functions to ensure alignment of safety priorities and actions
• Strengthening the overall safety capability of the organization through leadership, innovation, and knowledge sharing

Clinical Safety Leadership

• Lead and develop a team of safety scientists, drive performance, growth and scientific excellence
• Ensure appropriate resourcing and talent quality across assigned portfolio, including recruitment and team planning
• Lead initiatives for process improvement and cross-departmental process consistency
• Lead implementation of new processes, systems, and ways of working to enhance efficiency and scalability
• Provide oversight of vendors, including management, onboarding and training
• Represent GPS in clinical study teams and cross functional meetings
• Promote and enable cross-functional, proactive and solutions-orientated team actions and behaviors
• Lead work streams and/or projects with high impact to the business
• Participate as a core member of GPS leadership team

Portfolio Management Expertise

• Set safety team goals aligned to TA and product strategy
• Collaborate with medical directors to lead project-specific safety strategy for assets within the assigned portfolio
• Responsible for the overall scientific and clinical safety content for the assigned portfolio
• Responsible for the implementation and the high-quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned portfolio
• Provides strategic safety knowledge and support to the safety scientists through initiation, execution, and completion of the clinical programs for the assigned portfolio
• Responsible for the quality of key safety deliverables (e.g., Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs))
• Responsible for ensuring compliance and adherence to PV regulations for the assigned portfolio

Safety Expert

• Authoring or reviewing safety sections of clinical documents including but not limited to the clinical study protocol, informed consent form, Investigator's Brochure, statistical analysis plan, clinical study report, and data monitoring committee documents
• Coordinating, preparing, and completing high-quality aggregate safety reports (e.g., PSUR, PBRER, PADER) for submission to regulatory agencies globally
• Leading program and study level safety surveillance including the analysis and communication of safety data, authoring of internal safety review documents, presentation at cross-functional decision-making bodies and documentation/tracking of all signal analysis results
• Leading the authoring and project management of health authority queries
• Maintaining accountability for the authoring, review and finalization (i.e., endorsement, sign-off) of risk management plans and contributing to REMS documents
• Assisting GPS Medical Directors in the development of risk management strategy
• Supporting activities related to new drug applications and other regulatory filings including authoring, reviewing and providing input to eCTD modules (2.5 and 2.7.4),…