Director, Safety Scientist

The Director, Safety Scientist serves as a key leader within Global Patient Safety, providing strategic oversight and scientific leadership for the evaluation and management of safety risks across the portfolio through:Leading the scientific evaluation and management of safety risks across assigned programs, with accountability for high-quality, evidence-based outputsDriving proactive, data-informed safety strategies in close partnership with GPS Medical Directors and cross-functional stakeholdersEnsuring robust, timely, and aligned benefit–risk assessments throughout the product lifecycleOverseeing delivery of safety science activities, ensuring consistency, quality, and adherence to timelinesShaping safety strategy and recommendations that inform governance discussions and key decision-making forumsLeading, coaching, and developing a team of Safety Scientists, fostering scientific rigor, accountability, and continuous improvementPromoting consistency in scientific approach and execution across programs and team membersCollaborating effectively across clinical, regulatory, and other functions to ensure alignment of safety priorities and actionsStrengthening the overall safety capability of the organization through leadership, innovation, and knowledge sharingResponsibilities for this role include, but are not limited to:Clinical Safety LeadershipLead and develop a team of safety scientists, drive performance, growth and scientific excellenceEnsure appropriate resourcing and talent quality across assigned portfolio, including recruitment and team planningLead initiatives for process improvement and cross-departmental process consistencyLead implementation of new processes, systems, and ways of working to enhance efficiency and scalabilityProvide oversight of vendors, including management, onboarding and trainingRepresent GPS in clinical study teams and cross functional meetingsPromote and enable cross-functional, proactive and solutions-orientated team actions and behaviorsLead workstreams and/or projects with high impact to the businessParticipate as a core member of GPS leadership teamPortfolio Management ExpertiseSet safety team goals aligned to TA and product strategyCollaborate with medical directors to lead project-specific safety strategy for assets within the assigned portfolioResponsible for the overall scientific and clinical safety content for the assigned portfolioResponsible for the implementation and the high-quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned portfolioProvides strategic safety knowledge and support to the safety scientists through initiation, execution, and completion of the clinical programs for the assigned portfolioResponsible for the quality of key safety deliverables (e.g., Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs))Responsible for ensuring compliance and adherence to PV regulations for the assigned portfolioSafety ExpertAuthoring or reviewing safety sections of clinical documents including but not limited to the clinical study protocol, informed consent form, Investigator’s Brochure, statistical analysis plan, clinical study report, and data monitoring committee documentsCoordinating, preparing, and completing high-quality aggregate safety reports (e.g., PSUR, PBRER, PADER) for submission to regulatory agencies globallyLeading program and study level safety surveillance including the analysis and communication of safety data, authoring of internal safety review documents, presentation at cross-functional decision-making bodies and documentation/tracking of all signal analysis resultsLeading the authoring and project management of health authority queriesMaintaining accountability for the authoring, review and finalization (i.e., endorsement, sign-off) of risk management plans and contributing to REMS documentsAssisting GPS Medical Directors in the development of risk management strategySupporting activities related to new drug applications and other regulatory filings including authoring, reviewing and providing input to eCTD modules (2.5 and 2.7.4), core product information (i.e., CCDS), and local labelsRepresenting global patient safety at regulatory inspections (e.g., MHRA, FDA, EMA) Messaging and External ImpactMaintains a high degree of understanding and awareness of new and emerging clinical safety developments globallyMaintains strong networks globally; works with international colleagues and with external alliance partners on safety initiatives and regulatory issuesYou will have:Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner or PhDAt least 7+ years’ experience in drug safety/pharmacovigilance within the pharmaceutical industry or biotechSubject matter expertise in global pharmacovigilance regulations, maintaining a strong, up-to-date working knowledge of evolving global requirementsExperience with:Preparing aggregate safety reports and conducting signal surveillanceclinical development including risk/benefit analysis and safety assessmentRisk management and minimization programsProven skill set for strategic leadership in a cross functional matrixStrong analytical, problem solving, and scientific writing skillsDemonstrated learning agility and ability to work independentlySound, independent judgement based on knowledge and expertiseAdvanced project leadership with strong organizational and prioritization skillsStrong personal time-management and project-management skillsAbility to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basisUnderstanding of downstream regulatory, patient, business, and reputational impact of PV actionsWe would prefer you have:Expertise with clinical and safety databasesExperience in MedDRA coding and search strategiesExperience with data visualization tools (e.g., Power BI, Spotfire)Experience with various roles in drug safety (e.g., case processing, operations)Mastery of Microsoft Word, PowerPoint and ExcelThe annual base pay for this position ranges from $187K to $281K. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted04-Oct-2026Closing Date30-Oct-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.SummaryLocation: US - Boston - MAType: Full time