Global Pharmacovigilance Senior Medical Director

About this role

About Beeline Medicines:

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

Job Summary:

The Global Pharmacovigilance Senior Medical Director is the company's senior physician-level for drug safety, providing enterprise-wide medical and scientific leadership across all pharmacovigilance activities supporting the immunology and inflammation (I&I) pipeline, including the company's lead lupus program. As the principal physician for benefit-risk evaluation, signal assessment, and safety governance on specific program. This is a senior individual-expert role that leads through scientific insights and cross-functional influence: the Senior Director acts as company's primary physician representative to Health Authorities, Data Safety Monitoring Boards, and external advisory bodies for specific program(s) as needed. The Senior Director partners closely with Clinical Development, Regulatory Affairs, Medical Affairs, and Program Leadership to deliver 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 company's senior physician for safety science and pharmacovigilance, setting the medical standard for medical judgment on individual case safety reports (ICSRs), aggregate safety analyses, signal evaluations, and benefit-risk assessments across the I&I portfolio.

• Set the strategy and quality standards for medical review and clinical interpretation of safety data arising from clinical trials, spontaneous reports, literature, and real-world sources, and provide medical oversight of the PV vendor's safety evaluation output to ensure timely, accurate, and scientifically rigorous assessment of all pharmacovigilance data.

• Serve as the accountable medical authority for benefit-risk evaluations underpinning regulatory submissions, label negotiations, and Health Authority safety communications.

• Serve as senior medical lead to Clinical Development on Data Safety Monitoring Board (DSMB) strategy and interactions, clinical trial safety monitoring plans, safety risk mitigation strategy (e.g., stopping rules), and protocol-level safety sections for all active and planned studies.

• Direct the medical strategy for Risk Management Plans and safety-relevant regulatory documents across the full development lifecycle, including the design, execution, and effectiveness assessment of risk minimization measures.

• Provide medical leadership, scientific mentorship, and technical development to the Pharmacovigilance team, PV vendor personnel, and partner functions (e.g., Medical Writing, Clinical Operations), establishing a culture of medical excellence and patient-first decision-making.

• Provide senior medical oversight of emerging safety data and lead the safety-side response to emergent issues in collaboration with Medical Affairs and Regulatory Affairs.

• Serve as the safety lead for evaluation of target compound safety profiles, integrated benefit-risk assessment, and PV infrastructure readiness.

• Shape the strategy for integrating real-world safety evidence (including Epi work) records into the company's signal detection and benefit-risk evaluation framework.

• Perform other duties and responsibilities as assigned

Qualifications:

• Education: Medical degree (MD or DO) required; board certification in immunology, rheumatology, internal medicine, or a related specialty, with clinical experience in autoimmune disease, is strongly preferred

• Minimum of 10+ years of combined clinical and pharmaceutical/biotech industry experience, with at least 8–10 years of dedicated pharmacovigilance or drug safety experience in a senior medical role, including prior experience at Director level or equivalent. I&I experience preferred.

• Extensive track record serving as physician-of-record for pharmacovigilance programs across multiple compounds or indications, including ICSR medical review, signal evaluation, benefit-risk assessment, and aggregate safety reporting.

• Authoritative knowledge of global safety and pharmacovigilance regulations, including FDA guidance, EU GVP Modules I–XVI, and ICH guidelines, with proven ability to interpret and apply them to novel or ambiguous situations

• Demonstrated medical leadership of safety surveillance planning, benefit-risk assessment, and safety content for IND and NDA/BLA submissions, including direct authorship or final medical approval of complex safety narratives and integrated summaries of safety.

• Experience owning or leading Risk Management Plans (RMPs) and REMS programs, including development of risk minimization measures and assessment of their effectiveness.

• Deep knowledge of biologics safety considerations specific to immunology indications, including infection risk, immunosuppression, immunogenicity, and organ-specific toxicity in the…