Oncology Safety Senior Medical Director

AbbVie; Florham Park (NJ); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Comprehensive benefits

Paid time off

Long-term incentive programs

Job summary

AbbVie seeks a Product Safety Team (PST) lead for late-stage oncology programs. You will set strategy with the development medical lead and oversee safety through the product lifecycle, collaborating with safety scientists, PK/toxicology, regulatory and medical affairs to guide dose selection and safety monitoring.

You will interpret pharmacovigilance regulations, lead pre-NDA/NDA submissions, and drive risk management plans, medical safety assessments, and safety communications across programs.

Qualifications

• MD/DO with 2+ years of internal medicine residency.
• 2–5 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry.
• Oncology experience strongly preferred.
• Ability to lead cross-functional teams.
• Write, review and provide input on PV documents.
• Ability to interpret clinical data and epidemiological information.

Responsibilities

• Understand pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance.
• Responsible for safety surveillance for pharmaceutical/biological/drug–device products.
• Lead and set the strategy for PV documents, including medical safety assessments, regulatory responses and risk management plans (NDA/sNDA).
• Apply current regulatory guidance for PV surveillance and authorship of PV documents.
• Analyze and interpret aggregate safety data and communicate findings to cross-functional teams and leadership.
• Write, review and provide input on technical PV documents independently.
• Oversee and lead periodic safety reports (DSURs, PSURs, PADERs).
• Implement risk management strategies for assigned products and mentor the safety team.
• Collaborate with PK, toxicology, regulatory, clinical development and medical affairs.

Skills

Oncology exp

Pharmacovigilance

Cross-functional

Data analysis

Medical writing

Regulatory strategy

Education

MD/DO

PhD preferred

Job description

AbbVie seeks a Product Safety Team (PST) lead for late-stage oncology programs. You will set strategy with the development medical lead and oversee safety through the product lifecycle, collaborating with safety scientists, PK/toxicology, regulatory and medical affairs to guide dose selection and safety monitoring.

You will interpret pharmacovigilance regulations, lead pre-NDA/NDA submissions, and drive risk management plans, medical safety assessments, and safety communications across programs.