Medical Director, Senior Medical Director, Late Stage Oncology-Product Safety Team Lead

Summary

Join AbbVie's Product Safety Team as a PST Lead for late-stage oncology products. Collaborate closely with development and medical leads to strategize for oncology programs, ensuring product safety throughout the lifecycle. Responsibilities include safety surveillance, regulatory document preparation, risk management, and team leadership. The ideal candidate will possess an MD/DO with relevant residency experience, significant pharmacovigilance experience, and strong oncology expertise. AbbVie offers a comprehensive benefits package including paid time off, health insurance, and a 401(k). This role can be remote within the US.

Requirements

• MD / DO with 2+ years of internal medicine residency with patient management experience required
• 5 - 8 years of Pharmacovigilance (PST lead role equivalent) / Clinical Development experience in the pharmaceutical industry required
• Effectively analyze and guide analysis of clinical data and epidemiological information
• Effectively present recommendations / opinions in group environment both internally and externally
• Write, review and provide input on technical documents
• Work collaboratively and lead cross-functional teams
• Ability to lead cross-functional teams in a collaborative environment

Responsibilities

• Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
• Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products
• Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission – safety component
• Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
• Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams, executive leadership and externally, as needed
• Effectively write, review and provide input on technical documents independently
• Oversight and responsibility for leading the strategy for periodic reports (DSURs, PSURs, PADERs etc.)
• Responsible for implementing risk management strategies for assigned products
• Proactively engaging, inspiring, coaching and mentoring team and colleagues

Preferred Qualifications

• PhD or Clinical Pharmacology fellowship is preferred in addition to MD / DO, not required
• Oncology experience strongly preferred

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader