Vice President, Pharmacovigilance

Your Impact

Alpha-9 Oncology is seeking a Vice President, Pharmacovigilance (PV) to lead the company’s global drug safety function across radiopharmaceutical and radioligand therapy programs. This role combines strategic leadership and hands-on operational expertise, ensuring patient safety, regulatory compliance, and scalable PV operations in a rapidly growing clinical-stage biotech.

The VP will own the full PV lifecycle, from establishing and scaling systems and processes to overseeing safety data collection, case management, signal detection, and regulatory submissions. This role reports to the Chief Medical Officer and partners closely with Clinical Development, Regulatory Affairs, Quality, and external vendors/CROs.

How You'll Contribute

• 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.

The Skills You Bring

• MD or equivalent advanced scientific/medical degree.
• 10+ years of pharmacovigilance experience, including at least 5 years in senior leadership roles. Experience in oncology, radiopharmaceuticals, or radioligand therapy preferred.
• 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. Preferably as well experience with radiation-related AE monitoring and familiarity with dosimetry.
• 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%).

What's in it for you

At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.

Company Summary

Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.

Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.

More about Alpha-9 Oncology

Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.

We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.