Senior Medical Director, Immunology, Global Patient Safety

📋 Description

• Lead safety strategy for immunology products across development and lifecycle under Asset PST Lead
• Collaborate with development medical leads, safety scientists, regulatory, and clinical teams
• Interpret pharmacovigilance regulations and oversee safety components of submissions (NDA/sNDA)
• Develop and manage safety documents and periodic reports (DSURs, PSURs, PADERs)
• Provide risk management and mitigation strategies; support safety surveillance for product types
• Mentor team, co-author publications, and advance safety leadership

🎯 Requirements

• MD/DO with 2+ years of patient management experience
• 5+ years in patient safety within pharma industry; leadership experience
• Experience with MAAs or regulatory interactions; clinical development background
• Immunology/internal medicine experience preferred
• Ability to analyze clinical/epidemiological data and present recommendations
• Strong cross-functional leadership and document writing skills

🎁 Benefits

• Comprehensive benefits package; eligibility for long-term incentive programs
• Employer equal opportunity employer; variety of medical/dental/vision insurance and 401(k)
• Location-based compensation; pay ranges disclosed in posting
• Workplace flexibility with hybrid arrangements