Senior Director, Global Patient Safety Science

Rapport Therapeutics; Boston (MA); Hybrid; USD 245,000 - 270,000; Full time

Job summary

Rapport Therapeutics in Boston is seeking a seasoned safety surveillance leader to guide pharmacovigilance across clinical programs, from early to late phase, with a technology-enabled mindset.

You will lead risk management, develop safety strategies, and oversee DSURs, ICFs, and labeling while collaborating with Medical, Regulatory, Biostatistics, and Clinical Operations teams. Remote and hybrid options available.

Qualifications

• Postgraduate qualification (MD/PharmD/PhD) with 10+ years in drug safety and risk management.
• Experience leading in a matrix environment and with regulatory authorities (FDA/EMA).
• Strong analytical and strategic thinking, problem-solving, and decision-making.
• Excellent organizational and time-management skills.
• Strong interpersonal and communication skills, written and verbal.
• Experience in neuropsychiatric indications.

Responsibilities

• Lead safety surveillance strategy and risk management across clinical programs.
• Accountable for safety sections in protocols, IBs, ICFs, DSURs, RMPs, CCDS, and labeling.
• Participate in Data Monitoring Committees and review safety data.
• Contribute to regulatory submissions and respond to safety information requests.
• Advance signal management using fit-for-purpose tools and AI in safety surveillance.
• Drive process improvements in safety surveillance and data analysis.
• Oversee DSUR production and safety components of study reports.
• Provide medical review for complex IC.

Skills

Analytical thinking

Strategic thinking

Problem-solving

Decision-making

Leadership in matrix environment

Interpersonal skills

Communication skills

Time management

Organizational skills

Education

Postgraduate qualification (MD, PharmD, PhD/MSc in Life Sciences)

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,trainingand mentorship, building organizational confidence in responsible AI and digital transformation in safety surveillance.
• Drive continuous process improvement across safety surveillance, signalmanagementand aggregate data analysis, using data,technologyand stakeholder feedback to improve quality,efficiencyand 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 IC
• 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.

Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

CCPA disclosure notice can be found here.