Senior Director, Patient Safety Sciences (Oncology)

Location: Based out of the San Francisco or Boston office; minimal travel required

Base pay: $270,000–$310,000 annually, plus equity, bonus, and benefits.

Company

hirify.global is a clinical-stage biopharmaceutical company developing innovative therapies for patients with breast cancer and other solid tumors.

What you will do

• Lead the strategic planning and execution of patient safety and pharmacovigilance activities across the development portfolio.
• Develop safety-related sections for clinical and regulatory documents, including protocols, Investigator’s Brochures, benefit-risk assessments, and risk management plans.
• Provide medical review of SAEs, SUSARs, case narratives, MedDRA coding, expectedness, reportability, and sponsor assessments.
• Lead safety input for Data Monitoring Committee meetings, quality systems, audits, inspection readiness, and regulatory inspections.
• Develop and deliver safety training for employees, cross-functional partners, and clinical site personnel.
• Build, lead, coach, and develop a high-performing Safety Sciences team while assessing organizational capabilities and resource needs.

Requirements

• MD, PhD, PharmD, or equivalent degree from an accredited institution.
• At least 15 years of relevant drug safety experience in the biopharmaceutical industry, including oncology clinical trials.
• At least 6 years of progressive people leadership experience managing and developing high-performing teams.
• Strong knowledge of ICH, FDA, and EU regulations and guidelines governing patient safety and pharmacovigilance.
• Experience with registrational clinical development programs, regulatory filings, safety submissions, signal detection, benefit-risk evaluation, audits, and inspections.
• Demonstrated ability to lead through organizational growth, establish priorities, manage vendors, and strengthen quality and compliance.

Culture & Benefits

• Collaborative, science-driven, and cross-functional working environment.
• Focus on scientific rigor, quality, compliance, operational excellence, and continuous learning.
• Competitive compensation and benefits package, including equity and bonus.
• Open, flexible, and supportive environment focused on long-term professional development.
• Equal-opportunity workplace that values diverse expertise, backgrounds, and perspectives.