Director/Senior Director, Drug Safety & Pharmacovigilance (Oncology)

Location: Remote (U.S.); eligibility to work in the United States is required

Salary: $235,000–$310,000 per year, depending on experience, qualifications, and location.

Company

hirify.global Therapeutics is a Nasdaq-listed, clinical-stage oncology biotechnology company advancing the PIKTOR multi-node PI3K/AKT/mTOR inhibitor program.

What you will do

• Lead pharmacovigilance and drug safety activities across clinical development programs.
• Review clinical trial safety data and lead signal detection, evaluation, interpretation, and risk assessment.
• Oversee safety surveillance performed by CROs, pharmacovigilance vendors, and external consultants.
• Provide medical input for aggregate safety reports, DSURs, protocols, investigator brochures, informed consent forms, clinical study reports, and regulatory submissions.
• Support regulatory authority interactions and lead Safety Management Team meetings.
• Collaborate with Clinical Development, Regulatory Affairs, Clinical Operations, Medical Writing, and Biostatistics to advance programs through mid- and late-stage development.

Requirements

• At least 4 years of pharmacovigilance and drug safety experience in the pharmaceutical or biotechnology industry.
• Significant experience supporting oncology drug development programs, including Phase 2 and/or Phase 3 studies.
• Expertise in medical safety assessment, signal detection, risk management, and global pharmacovigilance regulations.
• Experience overseeing CROs, pharmacovigilance vendors, and external consultants.
• Strong communication, cross-functional collaboration, and independent working skills in a fast-paced biotechnology environment.
• Must be eligible to work in the United States.

Nice to have

• MD degree and board certification in Oncology, Hematology/Oncology, Internal Medicine, or a related specialty.
• Experience in both large pharmaceutical companies and small-to-mid-sized biotechnology organizations.
• Experience as the primary or lead medical safety physician for a development program.
• Experience supporting regulatory agency interactions related to drug safety.

Culture & Benefits

• 100% remote work with a flexible schedule.
• Health, dental, and vision coverage for employees and dependents.
• Flexible time off and generous parental leave.
• Traditional and Roth 401(k) plans.
• Equity in a well-funded, clinical-stage biotech and a mission-oriented, remote-first culture.