Director, Safety Sciences (Oncology)

Location: Based out of the Boston or San Francisco office, United States; less than 10% travel required

Base pay: $235,000–$255,000 annually, plus equity, bonus, and benefits

Company

hirify.global is a clinical-stage biopharmaceutical company developing oncology therapies, including palazestrant and OP-3136, for patients with metastatic breast cancer.

What you will do

• Lead clinical safety strategy, evaluation, and communication across the development lifecycle.
• Prepare and review safety components for NDA/BLA submissions, including ISS, SCS, clinical overviews, and regulatory modules.
• Integrate clinical, literature, and post-marketing safety data to support benefit-risk assessments and regulatory decision-making.
• Develop and maintain RMPs, REMS, aggregate safety reports, labeling materials, and other risk-management deliverables.
• Coordinate safety strategies and analyses with Clinical Development, Biostatistics, Regulatory Affairs, Medical Writing, Programming, QA, and external partners.
• Lead health authority meeting preparation, regulatory responses, cross-functional safety reviews, and inspection-readiness activities.

Requirements

• MD, PhD in medical or biological science, PharmD, or RN degree.
• Small-molecule oncology experience is required.
• At least 8+ years of pharmacovigilance or drug safety experience for MD, PhD, or PharmD candidates, or 10+ years for RN candidates.
• Experience with late-phase clinical development, registration, NDA/BLA submissions, submission readiness, ISS authoring or review, benefit-risk assessments, labeling strategy, and health authority interactions.
• Knowledge of FDA, EU, and ICH pharmacovigilance requirements, clinical databases or EDC, CTD/eCTD, and safety databases.
• Experience managing safety vendors, mentoring junior team members, improving processes, and maintaining SOPs; strong analytical, communication, planning, and interpersonal skills.

Culture & Benefits

• Equal-opportunity environment that values diverse expertise, backgrounds, and experiences.
• Open, flexible, and friendly work environment.
• Competitive compensation and benefits package.
• Equity and bonus opportunities.
• Platform for long-term professional development.