Senior Medical Director - Patient Safety

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

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programEligibility

Job summary

Scorpion Therapeutics is seeking an experienced Product Safety Team lead for oncology programs to partner with development medical leads and set safety strategy across the product lifecycle, including surveillance, signal detection, risk assessment, and mitigation plans.

This role requires MD/DO with oncology patient safety experience and 2–5 years in pharmacovigilance or clinical development, plus regulatory submission support and strong cross-functional leadership.

Qualifications

• MD/DO with 2+ years internal medicine residency and patient management experience.
• 2–5 years pharmacovigilance/clinical development experience.
• IND/BLA regulatory submission support experience required.
• Oncology patient safety experience required.

Responsibilities

• Lead safety surveillance across oncology products using pharmacology, non-clinical toxicology, and PV data.
• Set strategy for pharmacovigilance documents and safety responses for NDA/sNDA submissions.
• Analyze/interpret aggregate safety data and communicate recommendations internally and externally.
• Write and review technical safety documents and co-author publications.
• Lead periodic report strategy (DSURs, PSURs, PADERs) and risk management plans.
• Mentor team, collaborate with regulatory, clinical development, and medical affairs.

Skills

Pharmacovigilance

Cross-functional leadership

Data interpretation

Education

MD/DO

PhD/Clinical Pharmacology fellowship

Job description

The Product Safety Team (PST) lead for late-stage oncology products, under the Group Lead/TA Head, collaborating with development medical leads to set oncology program safety strategy. Responsible for one or more products and ensuring patient safety through the product lifecycle (surveillance, signal detection, validation/assessment, risk assessment and mitigations, tox management, etc.) with cross-functional safety teams. Collaborates with PK/toxicology leads, regulatory and clinical development leads, and medical affairs on dose selection/regimen, inclusion/exclusion criteria, and safety monitoring for first-in-clinical trials and PMOS. Interprets pharmacovigilance regulations and leads safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label/label updates, and RMPs.

Responsibilities

• Safety surveillance using pharmacology, chemistry, and non-clinical toxicology
• Safety surveillance for pharmaceutical/biological/drug–device combined products
• Set strategy for pharmacovigilance documents (medical safety assessments, regulatory responses, risk management plans, safety component of NDA/sNDA submissions)
• Apply regulatory guidance for safety surveillance and PV document authorship
• Analyze/interpret aggregate safety data; communicate internally, to leadership, and externally
• Write/review/provide input on technical documents
• Lead periodic report strategy (DSURs, PSURs, PADERs, etc.)
• Implement risk management strategies for assigned products
• Engage, coach, and mentor team; co-author publications; adapt in fast pace environment

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
• Prior regulatory submission support (IND/BLA) (required)
• Oncology patient safety experience (required)
• Ability to analyze clinical/epidemiological data; present recommendations internally/externally; write/review technical documents; lead cross-functional teams

Benefits

• Paid time off; medical/dental/vision insurance; 401(k); long-term incentive program eligibility