Job Summary

The Senior Director, Clinical Safety Science is a key leadership role responsible for shaping and advancing global safety strategy across the product lifecycle—from early development through post-marketing. This position oversees a team of Safety Scientists who partner with Safety Physicians and cross-functional stakeholders to ensure proactive safety surveillance, benefit-risk assessment, and risk mitigation planning for a group of assets. The Senior Director plays a pivotal role in influencing safety governance, driving innovation in safety science, and ensuring regulatory and compliance excellence. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.

Job Description

Responsibilities

• Strategic Safety Leadership: Provide scientific and strategic leadership for safety surveillance and risk management for a group of assets. Lead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries.
• Team and Talent Development: Lead, mentor, and develop a high-performing team of safety scientists supporting a group of assets. Champion a culture of scientific rigor, continuous learning, and collaboration. Ensure strategic alignment of talent to pipeline priorities, provide performance feedback, and guide professional growth to build future leadership.
• Innovation and Process Excellence: Maintain strong knowledge of the evolving safety science and regulatory landscape. Drive initiatives to enhance scientific methods, tools, and systems supporting safety surveillance and signal detection. Lead cross-functional and global projects to evolve safety science capabilities. Contribute to strategic planning and operating model design for CSPV.
• Compliance and Quality Oversight: Ensure all safety deliverables by the scientist team meet internal quality standards and are compliant with GCP/GVP and relevant global regulations. Support audits and inspections, contribute to CAPA development, and foster a culture of quality and accountability. 
• Resource Planning: Partner with CSPV portfolio management and product leads to forecast resource needs for a group of assets and align capacity with business priorities. Leverage metrics to inform decision-making and improve operational efficiency.

Qualifications

Education Qualifications

• PharmD or PhD degree in relevant discipline required 

Experience Qualifications

• At least 10 years of experience in clinical development, medical affairs or clinical safety/post marketing safety in the pharmaceutical industry required
• At least 5 years of experience in clinical safety/post marketing safety in the pharmaceutical industry preferred
• At least 5 years of people management experience required
• Experience in leading safety scientist teams in clinical studies, regulatory submissions, aggregate reports and post-marketing surveillance and risk management
• Excellent communication, project management, writing and analytic skills
• Demonstrated strong organizational leadership skills
• Extensive knowledge of the latest technical and regulatory development