Senior Medical Director - Patient Safety
AbbVie
August 25, 2026
Remote friendly (North Chicago, IL)
United States
$182,000 - $346,000 USD yearly
Medical Affairs
Responsibilities:
- Set strategy for late-stage oncology programs as Product Safety Team (PST) lead, collaborating with development medical leads and safety team.
- Ensure patient safety through the product lifecycle (surveillance, signal detection, validation/assessment, risk assessments and mitigations, tox management).
- Collaborate with PK/toxicology leads, regulatory and clinical development leads, and medical affairs on dose selection/regimen, inclusion/exclusion criteria, and safety monitoring for clinical trials and PMOS.
- Interpret pharmacovigilance regulations to support patient safety activities.
- Lead safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label and label updates, and Risk Management Plans (RMPs).
- Lead and execute pharmacovigilance document strategy (medical safety assessments, regulatory responses, risk management plans, NDA/sNDA safety components).
- Apply regulatory guidance for safety surveillance and authorship of PV documents.
- Analyze and interpret aggregate safety data and communicate to cross-functional teams, executive leadership, and external stakeholders as needed.
- Write/review/provide input on technical documents; oversee periodic reports (DSURs, PSURs, PADERs).
- Implement risk management strategies for assigned products.
- Engage, coach, and mentor teams; contribute to publications and safety leadership initiatives.
Qualifications:
- MD/DO with 2+ years internal medicine residency with patient management experience (required). PhD or Clinical Pharmacology fellowship (preferred).
- 2–5 years pharmacovigilance/clinical development experience in pharmaceutical industry.
- Prior regulatory submission support (IND/BLA) required.
- Oncology patient safety experience required.
- Ability to analyze and guide clinical/epidemiological data; present recommendations internally/externally.
- Ability to write/review technical documents and lead cross-functional teams.
Benefits:
- Paid time off; medical/dental/vision insurance; 401(k); eligible for long-term incentive programs.
- Set strategy for late-stage oncology programs as Product Safety Team (PST) lead, collaborating with development medical leads and safety team.
- Ensure patient safety through the product lifecycle (surveillance, signal detection, validation/assessment, risk assessments and mitigations, tox management).
- Collaborate with PK/toxicology leads, regulatory and clinical development leads, and medical affairs on dose selection/regimen, inclusion/exclusion criteria, and safety monitoring for clinical trials and PMOS.
- Interpret pharmacovigilance regulations to support patient safety activities.
- Lead safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label and label updates, and Risk Management Plans (RMPs).
- Lead and execute pharmacovigilance document strategy (medical safety assessments, regulatory responses, risk management plans, NDA/sNDA safety components).
- Apply regulatory guidance for safety surveillance and authorship of PV documents.
- Analyze and interpret aggregate safety data and communicate to cross-functional teams, executive leadership, and external stakeholders as needed.
- Write/review/provide input on technical documents; oversee periodic reports (DSURs, PSURs, PADERs).
- Implement risk management strategies for assigned products.
- Engage, coach, and mentor teams; contribute to publications and safety leadership initiatives.
Qualifications:
- MD/DO with 2+ years internal medicine residency with patient management experience (required). PhD or Clinical Pharmacology fellowship (preferred).
- 2–5 years pharmacovigilance/clinical development experience in pharmaceutical industry.
- Prior regulatory submission support (IND/BLA) required.
- Oncology patient safety experience required.
- Ability to analyze and guide clinical/epidemiological data; present recommendations internally/externally.
- Ability to write/review technical documents and lead cross-functional teams.
Benefits:
- Paid time off; medical/dental/vision insurance; 401(k); eligible for long-term incentive programs.