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 and safety support lead in close collaboration with Medical Science, Clinical Pharmacology, Clinical Operations, Regulatory Affairs, Biostatistics, Medical Affairs, Quality and Commercial organization on safety -related strategy and execution.
- Maintain deep expertise in global pharmacovigilance regulations, guidance, and industry best practices and ensure compliance with FDA, EMA, ICH, and other applicable global safety reporting requirements.
- Lead inspection readiness and support regulatory inspections and audits related to safety science and risk management.
Must-Haves:- A relevant postgraduate qualification (e.g., MD, PharmD, PhD/MSc in a Life Sciences discipline) with 10 or more years of drug development experience in drug safety which includes performance of safety surveillance/signal detection, and other related risk management activities with experience in neuropsychiatric indications.
- Demonstrated ability to lead and influence in a matrix environment. Experience with interacting and leading with Regulatory Authorities (i.e. FDA, EMA) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums.
- Experience with interacting and leading with Regulatory Authorities (i.e. FDA, EMA) at type C, B, 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, with the ability to prioritize and manage multiple tasks effectively.
- Strong interpersonal and communication (written and verbal) skills.
Your Compensation:We get it. Compensation is an important part of your offer. You shouldn't be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this? We tell you about our hiring range now - we expect the hiring range for the role to be $245,000 to $270,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don't stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company.
Hybrid Work Environment:We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday-Wednesday to create more opportunities for innovation, collaboration, and connection.
