[Remote] Head of Drug Safety and Pharmacovigilance

Note: The job is a remote job and is open to candidates in USA. Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. They are seeking a Head of Drug Safety and Pharmacovigilance to lead the global drug safety function, ensuring patient safety and regulatory compliance in a rapidly growing environment. The role involves strategic leadership, overseeing safety data collection, case management, and regulatory submissions.

Responsibilities

• Define and execute Alpha-9’s PV strategy, covering early clinical trials through post-marketing readiness
• Serve as the senior medical and scientific authority for drug safety, providing expert oversight of adverse event management, benefit-risk assessments, and safety signal evaluation
• Build, lead, and mentor a high-performing PV organization, including internal staff and external partners, fostering a culture of compliance, scientific rigor, and patient-centric safety
• Oversee PV operations and vendor management, ensuring high-quality case processing, timely reporting, reconciliation, and inspection-ready documentation
• Lead hands-on safety activities, including case review, literature surveillance, aggregate data analysis, and contribution to safety sections of regulatory submissions (INDs, IBs, DSURs, protocols, informed consent forms, and eventual NDA/MAA filings)
• Integrate PV insights across the company, collaborating with Clinical Operations, Regulatory Affairs, Biostatistics, and Quality to embed safety considerations into trial design and program planning
• Ensure compliance with global regulations, including FDA, EMA, ICH, GVP, CIOMS, and TGA, while maintaining inspection-ready PV systems and SOPs
• Represent Alpha-9 in regulatory interactions and inspections, providing transparency and scientific credibility
• Drive continuous improvement, implementing scalable PV processes, operational metrics, and governance frameworks suitable for a growing biotech Skills
• MD or equivalent advanced scientific/medical degree
• 10+ years of pharmacovigilance experience, including at least 5 years in senior leadership roles
• Proven track record designing, building, and scaling PV systems in early- or mid-stage biotech, including managing CROs and vendors
• Hands-on expertise with case processing, safety data review, aggregate reporting, and regulatory submissions
• Strong understanding of oncology related AE monitoring, first-in-human dose escalation, and long-term safety follow-up
• Deep knowledge of global PV regulations and inspection readiness requirements
• Exceptional leadership, analytical, and communication skills, able to translate complex safety data into actionable insights for internal and regulatory stakeholders
• Entrepreneurial, collaborative, and adaptable mindset suited to a fast-growing biotech
• Willingness to travel domestically and internationally (up to 25%)
• Experience in oncology, radiopharmaceuticals, or radioligand therapy preferred
• Preferably as well experience with radiation-related AE monitoring and familiarity with dosimetry Benefits
• Competitive salary
• Bonus
• Equity
• 20 vacation days
• 5 sick days
• Technology allowance
• Commuter reimbursement
• Generous retirement savings plans with employer matching
• Extended health benefits
• Paid holidays Company Overview
• Alpha-9 Oncology is a biopharma company that focuses on radiotherapeutics for the treatment of solid and hematologic malignancies. It was founded in 2019, and is headquartered in Vancouver, British Columbia, CAN, with a workforce of 51-200 employees. Its website is Apply tot his job Apply tot his job

Apply tot his job Apply To this Job