Medical Degree (MD, MBBS, or equivalent) required.
Clinical practice experience post-qualification.
Significant experience in Clinical Safety/Pharmacovigilance in pharma or biotech.
Strong knowledge of benefit-risk assessment and global pharmacovigilance regulations.
Experience with global regulatory safety documents and submissions.
Proven ability to influence in a matrix environment.
Responsibilities
Lead clinical safety strategy for assigned products and programs.
Drive medical evaluation of safety data and benefit-risk assessments.
Provide expert input into risk identification and mitigation activities.
Influence safety-related decisions within project teams.
Provide medical oversight of signal detection and risk evaluation activities.
Lead interpretation of safety data from various sources.
Contribute to risk management planning and strategies.
Benefits
Hybrid work model with 3 days on-site.
Opportunity to collaborate with cross-functional teams.
Mentorship opportunities within the organization.
Engagement in innovative medicine development.
Contribution to patient safety and responsible medicine delivery.
Full Job Description
Location: Kendal Square, Boston
Hybrid: 3 days a week on site
Medical Director, Senior Safety Physician
We are seeking an experienced physician to provide medical leadership for clinical safety and benefit-risk management across the lifecycle of assigned products and development programs. This role is accountable for shaping and executing safety strategy, evaluating emerging safety data, and ensuring the effective communication of safety information to internal and external stakeholders.
Working within a global, cross-functional environment, you will collaborate with experts across Clinical Development, Regulatory Affairs, Epidemiology, Safety Science, Risk Management, and Medical Affairs to protect patient safety and support the successful development and commercialization of innovative medicines.
Key Responsibilities
Clinical Safety Leadership
Lead the clinical safety strategy for assigned products and programs.
Drive medical evaluation of safety data and benefit-risk assessments.
Provide expert input into risk identification, characterization, and mitigation activities.
Influence safety-related decisions within project teams and governance forums.
Safety Surveillance and Risk Management
Provide medical oversight of signal detection, safety surveillance, and risk evaluation activities.
Lead interpretation of safety data from clinical trials, post-marketing experience, literature, and other relevant sources.
Contribute to risk management planning and the development of appropriate risk minimization strategies.
Ensure alignment of safety strategy with development and lifecycle objectives.
Regulatory Safety and Governance
Lead and review key regulatory safety deliverables, including DSURs, PBRERs, PADERs, safety responses, and other global submissions.
Support major regulatory submissions and interactions with health authorities.
Present safety assessments and recommendations to governance committees and senior stakeholders.
Cross-Functional Leadership
Serve as the Patient Safety representative in clinical project teams.
Build effective partnerships across Clinical Development, Regulatory Affairs, Safety Science, Medical Affairs, and other key functions.
Support due diligence, licensing, and business development activities when required.
Mentor colleagues and contribute to a culture of scientific excellence, collaboration, and continuous improvement.
Essential Requirements
Medical Degree (MD, MBBS, or equivalent).
Clinical practice experience following medical qualification.
Significant experience in Clinical Safety/Pharmacovigilance within the pharmaceutical or biotechnology industry.
Strong knowledge of benefit-risk assessment, risk management, signal detection, and global pharmacovigilance regulations.
Experience preparing or reviewing global regulatory safety documents and submissions.
Proven ability to influence and lead within a matrix environment.
Preferred Qualifications
Advanced training in Pharmaceutical Medicine or a related discipline.
Experience across multiple therapeutic areas and stages of product development.
Experience mentoring or leading safety professionals.
What Success Looks Like
Sound medical judgement and strategic thinking.
Strong collaboration and stakeholder management skills.
Ability to communicate complex safety information clearly and effectively.
Passion for advancing patient safety and delivering medicines responsibly.
Date Posted 15-Oct-2026
Closing Date 14-Dec-2026
About AstraZeneca
AstraZeneca is a British-Swedish multinational pharmaceutical company that specializes in the research, development, and manufacturing of prescription drugs. The company was formed in 1999 through the merger of Astra AB and Zeneca Group plc. AstraZeneca's products are used to treat a wide range of medical conditions, including cancer, cardiovascular disease, respiratory disease, and diabetes. The company has operations in over 100 countries and employs more than 76,000 people worldwide. AstraZeneca is committed to developing innovative medicines that improve the health and well-being of people around the world.
