Global Safety Medical Director, Early Development Rare Disease

Location: United States — Remote

Annual salary: $256,606.50–$347,173.50

Company

hirify.global is a biotechnology company developing and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead safety strategy for Rare Disease assets across early and late-stage clinical development and applicable post-marketing activities.
• Provide medical safety input into clinical development plans, dose selection, safety monitoring, and benefit-risk assessments.
• Review safety data, validate and assess safety signals, and communicate implications to development teams and senior governance committees.
• Lead or contribute to Safety Review Committees, Data Monitoring Committees, the Safety Analysis Team, and the Global Safety Team.
• Develop core safety information, risk management plans, periodic aggregate reports, and safety sections of regulatory submissions.
• Provide strategic safety input into protocols, CRF design, statistical analysis plans, clinical study reports, and inspection readiness.

Requirements

• MD or DO degree from an accredited medical school.
• Completion of an accredited medical or surgical residency, or clinical experience in an accredited academic, private-practice, or hospital-based setting.
• 5+ years of drug safety or pharmacovigilance experience in the biopharmaceutical industry or regulatory environment.
• Experience leading safety for Phase 1–3 clinical development programs, including early clinical development and first-in-human studies.
• Expertise in safety signal detection, benefit-risk evaluation, risk management, and regulatory submissions.
• Experience leading cross-functional teams and influencing development strategy in a matrix environment.

Nice to have

• Expertise in Rare Disease therapeutic areas or relevant clinical training.
• Experience with marketed product safety and post-marketing risk management.
• Experience presenting safety assessments to governance committees and health authorities.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.
• Flexible work models, including remote and hybrid arrangements where possible.