Senior Director, Global Patient Safety Science

Rapport Therapeutics•Boston, MA

5d•$245,000 - $270,000•Hybrid

About The Position

Rapport Therapeutics is hiring a Senior Director, Global Patient Safety Science to support patient safety across all clinical development programs, from early through late phase. The role leads safety strategy and risk management, using scientifically robust information from clinical trials, real-world data, literature, preclinical findings, and other relevant sources to evaluate and contextualize potential safety signals. The successful candidate will maintain expert knowledge of assigned products’ safety profiles and provide scientific, clinical, and pharmacovigilance expertise and strategic context to clinical development deliverables and activities. This high-visibility position leads safety surveillance, signal management, aggregate data analysis, and risk management. It partners closely with Medical Science, Clinical Pharmacology, Clinical Operations, Regulatory Affairs, Biostatistics, Medical Affairs, Quality, and Commercial teams. The role also advances safety capabilities through fit-for-purpose tools and technology, training, mentorship, and continuous process improvement, while supporting compliance with global pharmacovigilance regulations and inspection readiness. The ideal candidate is based in Boston, Massachusetts, with onsite presence Monday through Wednesday. The role is also open to hybrid onsite work in San Diego or remote candidates. The hiring range is $245,000 to $270,000; the actual offer may vary based on relevant skills, experience, location, salary market data, and internal equity. Rapport states that it offers a benefits package, but does not specify the benefits in the posting.

Requirements

Relevant postgraduate qualification, such as an MD, PharmD, or PhD/MSc in a life sciences discipline.
At least 10 years of drug development experience in drug safety, including safety surveillance or signal detection and related risk management activities.
Experience in neuropsychiatric indications.
Demonstrated ability to lead and influence in a matrix environment.
Experience interacting with and leading work with regulatory authorities such as the FDA and EMA at Type C or Type B meetings, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums.
Strong analytical and strategic thinking, problem-solving, and decision-making skills.
Strong organizational and time-management skills, including the ability to prioritize and manage multiple tasks effectively.
Strong written and verbal interpersonal and communication skills.

Responsibilities

Develop and operationalize safety surveillance strategy, identify potential clinical safety issues, and recommend appropriate risk mitigation measures.
Lead risk management activities, including preparing and maintaining relevant sections of clinical trial protocols, Investigator’s Brochures (including reference safety information), informed consent forms, DSURs, RMPs, CCDS, and labeling, as required.
Participate in internal and external Data Monitoring Committees by reviewing safety data, providing insights and leadership, and developing DMC charters.
Contribute to regulatory authority submissions, including INDs, NDAs, and MAAs, and respond to regulatory authority requests for information.
Advance signal management capabilities through fit-for-purpose tools, technology, training, and mentorship, including building organizational confidence in responsible AI and digital transformation in safety surveillance.
Improve processes across safety surveillance, signal management, and aggregate data analysis using data, technology, and stakeholder feedback to improve quality, efficiency, and consistency.
Lead DSUR production and the safety components of clinical study reports and other regulatory documents.
Serve as a resource for medical review of complex individual case safety reports and other data sources for assigned programs, and perform medical review as needed.
Participate in developing and maintaining relevant SOPs, working practices, and guides.
Serve as a key analytic and safety support lead, collaborating with Medical Science, Clinical Pharmacology, Clinical Operations, Regulatory Affairs, Biostatistics, Medical Affairs, Quality, and Commercial on safety-related strategy and execution.
Maintain expertise in global pharmacovigilance regulations, guidance, and industry best practices, and ensure compliance with applicable FDA, EMA, ICH, and other global safety reporting requirements.
Lead inspection readiness and support regulatory inspections and audits related to safety science and risk management.
Maintain expert understanding of assigned products’ safety profiles and provide scientific, clinical, pharmacovigilance, and strategic expertise to clinical development activities.