Group Medical Director, Late Stage Oncology

Summary

Join AbbVie as a Medical Director and lead Product Safety Teams, ensuring the safety of a hematology-oncology portfolio. You will collaborate with R&D, interpret regulations, and guide safety physicians. This role requires strong leadership, strategic thinking, and expertise in pharmacovigilance. You will manage other medical directors and oversee safety surveillance activities for products in clinical trials and post-marketing. The ideal candidate possesses an MD/DO, extensive pharmacovigilance experience, and strong analytical and communication skills.

Requirements

• MD / DO with 2+ years of residency with patient management experience
• 8 - 10 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
• 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
• Fluency, both written and oral, in English
• Evaluate and make independent decisions. Ability to work effectively in the situation of uncertainty and complexity, ability to multitask

Responsibilities

• Connect within R&D, particularly with key functions (Reg, ASL, Risk Mgt, etc)
• Serve as asset strategy lead safety representatives for larger programs (late stage)
• Understand MOA in close collaboration with preclinical, clinical pharmacy, clinical development, and discovery
• Work closely with Executive Medical Director to establish safety strategy for each indication and across assets with similar MOA
• Lead and guide the safety physicians on data review (clinical and beyond) and interpretations across assets with similar MOA
• Proactively seek to understand “WHY” a safety concern or risk emerge and “How” to mitigate it
• Understand and apply the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
• Be 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
• 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
• Effectively write, review and provide input on technical documents independently
• Oversee and lead the strategy for periodic reports (PSUR’s, PADER’s etc.)
• Oversee safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing
• Implement risk management strategies for assigned products
• Proactively engage, inspire, coach and mentor team and colleagues
• Manage other Associate Medical Directors, Medical Directors, Senior Medical Directors: performance and talent management, coaching and development
• Assume responsibility for coordinating and overseeing safety related activities at a product level across multiple indications or multiple related products for the same indication
• Assess product safety strategy across the entire program and oversee approval related activities

Preferred Qualifications

• Master Public Health or PhD in addition to MD / DO
• Ability to work collaboratively with colleagues with different areas of expertise (e.g epidemiology, statistics)
• Ability to make independent decisions
• Ability to influence cross functional stakeholders - internal and across industry, and regulatory authorities
• A clear understanding of PV and clinical development and monitoring clinical trial and post -marketing safety
• Ability to respect other opinions and be inclusive of the different point of views and be open to the ideas of others

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs