Job Summary:

The Pharmacovigilance Medical Director is the senior medical authority within the company's drug safety function, responsible for providing expert medical and scientific leadership across all pharmacovigilance activities supporting the immunology and inflammation (I&I) pipeline, including the company's lead lupus program. This role serves as the primary physician voice for benefit-risk evaluation, signal assessment, and safety governance, ensuring that patient safety is upheld as the foundational principle of all clinical development and post-market activities. The Medical Director partners closely with the Head of Pharmacovigilance, Clinical Development, Regulatory Affairs, Medical Affairs, and external Health Authorities to provide medically sound, strategically aligned safety leadership at a critical stage of the company's growth.

Work Arrangement & Location:

Remote - This position is designated as remote; the incumbent will be expected to travel to Beeline Medicines’ offices on a periodic basis to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such visits will be determined at the company's discretion based on business need.

Essential Duties and Responsibilities:

• Serve as the senior medical expert and physician for safety science and pharmacovigilance activities, providing authoritative medical judgment on individual case safety reports (ICSRs), aggregate safety analyses, signal evaluations, and benefit-risk assessments across the I&I portfolio.
• Lead the medical review and clinical data interpretation of safety data arising from clinical trials, spontaneous reports, literature, and real-world sources, ensuring timely, accurate, and scientifically rigorous assessment of all pharmacovigilance data.
• Direct the development and continuous maintenance of the company's benefit-risk framework, providing medical leadership in benefit-risk evaluations for regulatory submissions, label updates, and Health Authority safety communications.
• Lead the discussion at the company's Safety surveillance governance, providing medical and strategic direction on safety signal management, escalation procedures, and corrective action planning.
• Oversee the medical content and scientific quality of all aggregate safety reports, and regulatory submission dossiers for safety content.
• Partner with Clinical Development on the medical oversight of Data Safety Monitoring Board (DSMB) activities, clinical trial safety monitoring plans, safety risk mitigation plans (e.g.stopping rules), and protocol-level safety sections for all active and planned studies.
• Provide expert medical input to Risk management plans and relevant regulatory documents through developmental cycle of the programs, and risk minimization measure design, execution, and effectiveness assessment.
• Provide medical leadership and scientific mentorship to the Pharmacovigilance team, including PV Scientists, and other functions (e.g. Medical Writers, and Operations personnel) establishing a culture of medical excellence and patient-first decision-making.
• Perform other duties and responsibilities as assigned

Qualifications:

• Medical degree (MD or DO) required; board certification or eligibility in immunology, rheumatology, internal medicine, or a relevant specialty experience in autoimmune disease is strongly preferred
• Minimum of 5 years of combined clinical and pharmaceutical/biotech industry experience, with at least 2-3 years of dedicated pharmacovigilance or drug safety experience preferred.
• Demonstrated expertise serving as a physician-of-record for pharmacovigilance programs, including ICSR medical review, signal evaluation, benefit-risk assessment, and aggregate safety reporting.
• Deep knowledge of global safety and pharmacovigilance regulations including FDA guidance, EU GVP Modules I–XVI and ICH guidelines
• Extensive experience providing medical leadership for safety surveillance plan, and benefit-risk assessment, and submissions for IND and NDA/BLA, as well as direct authorship or oversight of complex safety narratives for regulatory submissions.
• Proven experience engaging with global Health Authorities on pharmacovigilance topics, including regulatory meeting preparation, written responses to safety queries, and inspection support.
• Demonstrated ability to lead or participate in DSMB oversight, clinical trial safety monitoring, and safety governance committee activities at the sponsor level.
• Experience contributing to Risk Management Plans (RMPs) and REMS programs, including development of risk minimization measures and assessment of effectiveness.
• Demonstrated ability to lead, mentor, and develop cross-functional teams in a fast-paced, resource-constrained biotech or pharmaceutical environment; fosters a culture of accountability, inclusion, and continuous learning.
• Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex scientific or operational priorities.
• Exceptional written and verbal communication skills with demonstrated ability to translate complex scientific, regulatory, or operational content for diverse audiences, including executive leadership, clinical teams, and external partners.
• Skilled at preparing and delivering compelling presentations, briefing documents and regulatory responses, and strategic updates to cross-functional leadership teams and board-level stakeholders.