Senior Medical Director, Immunology, Global Patient Safety

Indication Product Safety Team (PST) lead for immunology products under the Asset PST Lead; set the safety strategy for a product in development or an approved indication and support safety through the product lifecycle (surveillance, signal detection, validation/assessment, risk assessment and mitigation strategies). Collaborate with development medical leads; statistical science, epidemiology, regulatory, clinical development, and medical affairs teams.

Interpret pharmacovigilance regulations and lead safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label/label updates, RMPs, PSURs, and IB updates.

Responsibilities:
- Analyze and interpret aggregate safety data and communicate to cross-functional teams, executive leadership, and externally as needed
- Lead strategy for key pharmacovigilance documents (medical safety assessments, regulatory responses, risk management plans, NDA/sNDA safety components)
- Apply regulatory guidance for safety surveillance and authorship of PV documents
- Understand patient safety evaluations (pharmacology and non-clinical toxicology)
- Write, review, and independently provide input on technical documents
- Lead periodic report strategy (DSURs, PSURs, PADERs, etc.)
- Ensure safety surveillance for pharmaceutical/biological/drug-device combined products
- Implement risk management strategies for assigned products
- Coach/mentor team and colleagues; support fast-paced execution
- Co-author publications and participate in initiatives as a safety leader

Qualifications:
- MD/DO with 2+ years patient management experience (required)
- 5+ years patient safety experience in pharma with relevant leadership experience (required)
- Prior involvement in marketing authorization submissions or regulatory interactions
- Prior clinical development experience
- Immunology/internal medicine experience strongly preferred
- Experience analyzing clinical/epidemiological data; presenting recommendations internally/externally; writing/reviewing technical documents
- Ability to lead cross-functional teams

Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees
- Eligible for long-term incentive programs

Application instructions: Not specified.