Senior Director, Global Patient Safety Science at Rapport Therapeutics in Boston, MA

Job description

When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, we’re driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And we’re doing this with extraordinary science and awesome people (affectionately called Rapptors). Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials in primary generalized tonic-clonic seizures (PGTCS) and bipolar disorder. The strength of Rapport comes from our Rapptors – who are united by our mission to improve patients lives. We bring the heart and hustle to advance our science forward, always staying true to our core values. We hope you’re as excited about this opportunity as we are! The ideal candidate for this role is based in Boston, MA with onsite presence Monday-Wednesday; this role is also open to hybrid onsite in San Diego or to remote candidates. Your impact: In this high-visibility role, you will support patient safety across all clinical development programs, including early and late phase development. As an accomplished signal detection and safety surveillance leader with a forward thinking, technology enabled mindset, you will lead safety strategy and risk management supported by scientifically robust data sources including clinical trials, real-world data, literature, preclinical findings, and other relevant data sources and guide the team in evaluating and contextualizing potential safety signals. Your day-to-day: You will develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as provide scientific, clinical, and pharmacovigilance expertise along with relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action, etc.) and support for key deliverables and activities in clinical development including: Lead the development and operationalization of safety surveillance strategy, identification of potential clinical safety issues, and recommend appropriate risk mitigation measures. Accountable for risk management activities including preparation and maintenance of relevant sections of clinical trial protocols, IBs (including the reference safety information section), ICFs, DSURs, RMPs, CCDS, and labelling, as required. Participate in internal and external Data Monitoring Committees through review of safety data, insights and leadership and development of DMC Charters. Contribute to regulatory authority submissions (Investigational New Drug applications, New Drug Applications, Marketing Authorization Applications, etc.) including responding to regulatory authority requests for information. Continuously advance signal management capabilities through fit-for-purpose tools, technology, training and mentorship, building organizational confidence in responsible AI and digital transformation in safety surveillance. Drive continuous process improvement across safety surveillance, signal management and aggregate data analysis, using data, technology and stakeholder feedback to improve quality, efficiency and consistency. Accountable for DSUR production and the safety components of study reports (i.e., CSRs) and other regulatory documents. Act as a resource for medical review for complex ICSRs and may perform medical review as needed, and other data sources of assigned programs. Actively participate in the development and maintenance of relevant SOPs, working practices and guides Serve as key analytic an