Your Impact
The Senior Director, Pharmacovigilance (MD) will lead the strategy and execution of pharmacovigilance activities for Alpha-9 Oncology’s radioligand therapy programs. This role ensures patient safety, regulatory compliance, and effective benefit-risk evaluation across clinical development. The Senior Director will serve as a trusted medical authority for safety, oversee internal and external PV teams, and collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, and Quality. The Senior Director will report to the Chief Medical Officer.
How You’ll Contribute
- Establish and execute pharmacovigilance strategy for Alpha-9’s radioligand therapy programs, spanning early clinical trials through post-marketing surveillance as programs advance.
- Oversee collection, review, and analysis of safety data, including serious adverse events, signal detection, and risk management, ensuring compliance with GCP, GVP, ICH, and local regulations.
- Author and review safety-related sections of key regulatory documents, including INDs, IBs, DSURs, protocols, informed consent forms, and eventual NDA/MAA submissions.
- Build and manage internal PV teams and oversee external vendors/CROs, ensuring high-quality case processing and inspection-ready operations.
- Serve as the medical authority for safety, including regulatory inspections, authority interactions, and safety governance.
- Collaborate with Clinical Operations, Regulatory Affairs, and Biostatistics to integrate safety considerations into clinical development planning.
- Mentor and develop a high-performing PV team, fostering a culture of scientific rigor, compliance, and patient-centric safety.
The Skills You Bring
- MD, DO, or equivalent medical degree with U.S. board eligibility/certification and 5+ years of pharmacovigilance or drug safety experience (including 3+ years in leadership), with direct experience in radiopharmaceutical or radioligand therapy (RLT) programs required.
- Proven expertise designing and executing PV strategies for RLT, including radiation-related AE management (hematologic, renal, hepatic, marrow), dosimetry oversight, first-in-human dose escalation studies, and long-term follow-up for delayed or cumulative toxicities.
- Deep knowledge of global PV regulations for radiopharmaceuticals (FDA, EMA, TGA, ICH) and experience authoring/reviewing safety sections of regulatory submissions (IND/IMPD, DSUR, IB, RMP, NDA/BLA).
- Track record managing cross-functional PV teams, vendors, and CROs, ensuring compliance and inspection readiness in radiopharmaceutical trials.
- Strong ability to assess benefit-risk profiles integrating safety, efficacy, and radiation exposure data, and to communicate complex findings to regulatory and internal stakeholders.
- Entrepreneurial and collaborative mindset suited to a small, fast-growing biotech; adept at building and scaling PV systems and processes.
- 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.
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