Senior Medical Director - Patient Safety (Pharmacovigilance)

Location: United States; locations listed include North Chicago, Illinois, and Irvine, California

Salary: $182,000–$346,000 annually

Company

hirify.global develops medicines and solutions across immunology, oncology, neuroscience, and aesthetics.

What you will do

• Lead patient safety strategy for late-stage oncology products across the product lifecycle.
• Conduct safety surveillance, signal detection, validation, assessment, and risk mitigation for pharmaceutical, biological, and drug-device combination products.
• Lead medical safety assessments, risk management plans, periodic reports, regulatory responses, and safety components of NDA/sNDA submissions.
• Analyze aggregate clinical safety data and epidemiological information, communicating recommendations to cross-functional teams, executive leadership, and external stakeholders.
• Support dose selection, treatment regimens, eligibility criteria, and safety monitoring for clinical trials and post-marketing activities.
• Coach and mentor colleagues while leading cross-functional collaboration with clinical development, toxicology, regulatory, medical affairs, and safety teams.

Requirements

• MD or DO with at least two years of internal medicine residency and patient management experience.
• 2–5 years of pharmacovigilance or clinical development experience in the pharmaceutical industry.
• Previous experience supporting IND or BLA regulatory submissions.
• Oncology patient safety experience.
• Ability to analyze clinical and epidemiological data, write and review technical documents, and present recommendations internally and externally.
• Ability to lead cross-functional teams in a collaborative, fast-paced environment.

Nice to have

• PhD or clinical pharmacology fellowship in addition to an MD or DO.
• Experience co-authoring publications or participating in initiatives focused on patient safety leadership.

Culture & Benefits

• Paid vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Eligibility to participate in long-term incentive programs.
• Opportunities for professional development and safety leadership growth.