Senior Medical Director-Late Stage Oncology

Role Summary

Senior Medical Director-Late Stage Oncology. Leads product safety strategy for late-stage oncology programs, collaborating with development medical leads and cross-functional teams to oversee safety throughout the product lifecycle, support regulatory submissions, and guide dose selection and safety monitoring for clinical trials.

Responsibilities

• Understanding and application of pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
• Responsible for safety surveillance for pharmaceutical / biological / drug‚Äìdevice combined products
• Lead and set the strategy for key pharmacovigilance documents, including medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission ‚Äì 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 analyses 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
• Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader
• Strong team player, able to adapt and work in a fast-paced environment

Qualifications

• MD / DO with 2+ years of medical residency with patient management experience required; PhD or Clinical Pharmacology fellowship is preferred in addition to MD / DO, not required
• 5 - 8 years of Pharmacovigilance (PST lead role equivalent) / Clinical Development experience in the pharmaceutical industry required
• Oncology experience strongly preferred
• 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