Director, Risk Management Product Lead
Scorpion Therapeutics, Phila, Pennsylvania, United States
Role Summary
Provide strategic expertise to product teams and drive the execution of Risk Management (RM) activities included within RMP (Risk Management Plans) across business units to embed a culture of innovative and efficient risk management strategies to enhance patient safety. Collaborates in the development of innovative methods to develop the next generation Risk Management Center of Excellence (RMCoE). Partners with the RMCoE Head to instate and maintain processes and changes. Champions for managing and building the risk management knowledge for the organization. Provides expertise regarding RMP requirements and implementation for pre-marketed and post-marketed drug products. Recommends appropriate risk mitigation options for drug related safety issues, taking into account the benefit-risk profile of the drug, and approaches used for other products internal and external to Pfizer. Reviews RMP assessment reports to determine if modifications are required. In collaboration with RMCoE Head, develops/evolves/implements best practices in risk management planning, including risk communication, risk minimization and in benefit/risk assessment methodologies. Responsibilities
In collaboration with RMCoE Head, develops/evolves/implements best practices in risk management planning, including risk communication, risk minimization and in benefit/risk assessment methodologies. Supports Safety Surveillance & Risk Management (SSRM) with strategic guidance for risk management planning, taking into consideration local regulatory requirements, risk management best practices, and product specific risk profile, and development and implementation of RMP initiatives for products within the Pfizer portfolio Serves as the key interface between RAM and the BU in matters related to oversight of implementation and tracking of commitments included within the RMP and provide periodic updates regarding the status of implementation to the RMC Leads PRMS using effective leadership and process management techniques. Builds appropriate agendas, provides draft and final minutes and drives the actions to completion. Responsible for the storage and tracking of action items from meetings. Ensures appropriate membership attendance for internal and external meetings, including external expert engagement and briefing. Manages supplier performance/delivery relative to defined and agreed upon SOW; support managing day-to-day supplier communications. Provides regular reporting on all aspects of RMP milestones/performance per specific targets as defined by key performance indicators (KPIs) and/or regulatory commitments through maintenance and presentation of project performance dashboards. Creates/maintains project planning and execution documentation including, but not limited to, project charters, detailed project plans/milestones, progress reports, activity logs and deliverables, i.e. RMP submissions. Updates/maintains assigned project related documentation as per defined in risk management processes and file structure on designated system. Provides risk management education to internal and external colleagues With oversight, participates in audits and inspections; preparing and coordinating responses; participates in inspection readiness. Acts as a SME or BPO for a Safety SOP. Manages special projects and assists with communications. Provides guidance and coaching to less experienced RMPLs, participates in initial training of newly hired RMPLs, acts as first point of contact to assist other RMPLs in issue resolution. Has the foresight and judgement to recommend and then manage external safety KOL consultations, expert working groups, and other external safety forums. Implements opportunities identified for consistency and standardization in Safety Identifies and evaluates issues and presents strategies to ensure that timelines are met or accelerated. Influences above country and local individuals responsible for Safety, Regulatory, and Medical for appropriate risk management development and implementation Qualifications
Required: Bachelors degree and 8+ years of experience or Masters degree and 7+ years of experience or Pharm.D, or Ph.D, or equivalents and 1+ years of industry experience Required: Minimum 10 years of broad and progressive pharma experience in medical, clinical or pharmacovigilance with a clear focus on drug safety risk management Required: Knowledge of global safety regulations and guidelines, or equivalent Required: Demonstrated experience in global drug safety risk management planning activities and generating RMPs Required: Demonstrated strength in analytical skills and attention to detail Required: Demonstrated strength in oral/written communication, negotiation, and interpersonal skills Required: Demonstrated organizational/project management skills Required: Familiarity with management of performance metrics Required: Significant knowledge of organization processes and matrix-based decision-making Preferred: Project management certification (PMP) and Six Sigma Certification Skills
High level analytical skills - Detail oriented, independent, and manage processes to both establish timelines and ensure timelines are met Strategic Thinking – Analyze, frame, and communicate complex issues; writing and presentation proficiency Clinical, Regulatory and Safety Expertise - Knowledge of clinical research processes, safety or regulatory requirements; knowledge of Risk Management regulations and drug development process Technical Expertise – Applies technical and line knowledge of key concepts in own discipline Scientific/Administrative Excellence - Ability to evaluate and document review and analysis of data Organizational Development – Knowledge of organizational development principles and implementation of strategies Project and Process Management – Manage multiple complex projects and cross-functional processes; budgetary management Computer applications - MS Word, Excel, PowerPoint; familiarity with department systems Matrix collaboration skills to engage global Safety colleagues and relevant stakeholders across Regulatory, Clinical, Nonclinical, Medical, and in-country teams Additional Requirements
Last date to apply: January 29, 2026 Work Location Assignment: Hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week or more as needed
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Provide strategic expertise to product teams and drive the execution of Risk Management (RM) activities included within RMP (Risk Management Plans) across business units to embed a culture of innovative and efficient risk management strategies to enhance patient safety. Collaborates in the development of innovative methods to develop the next generation Risk Management Center of Excellence (RMCoE). Partners with the RMCoE Head to instate and maintain processes and changes. Champions for managing and building the risk management knowledge for the organization. Provides expertise regarding RMP requirements and implementation for pre-marketed and post-marketed drug products. Recommends appropriate risk mitigation options for drug related safety issues, taking into account the benefit-risk profile of the drug, and approaches used for other products internal and external to Pfizer. Reviews RMP assessment reports to determine if modifications are required. In collaboration with RMCoE Head, develops/evolves/implements best practices in risk management planning, including risk communication, risk minimization and in benefit/risk assessment methodologies. Responsibilities
In collaboration with RMCoE Head, develops/evolves/implements best practices in risk management planning, including risk communication, risk minimization and in benefit/risk assessment methodologies. Supports Safety Surveillance & Risk Management (SSRM) with strategic guidance for risk management planning, taking into consideration local regulatory requirements, risk management best practices, and product specific risk profile, and development and implementation of RMP initiatives for products within the Pfizer portfolio Serves as the key interface between RAM and the BU in matters related to oversight of implementation and tracking of commitments included within the RMP and provide periodic updates regarding the status of implementation to the RMC Leads PRMS using effective leadership and process management techniques. Builds appropriate agendas, provides draft and final minutes and drives the actions to completion. Responsible for the storage and tracking of action items from meetings. Ensures appropriate membership attendance for internal and external meetings, including external expert engagement and briefing. Manages supplier performance/delivery relative to defined and agreed upon SOW; support managing day-to-day supplier communications. Provides regular reporting on all aspects of RMP milestones/performance per specific targets as defined by key performance indicators (KPIs) and/or regulatory commitments through maintenance and presentation of project performance dashboards. Creates/maintains project planning and execution documentation including, but not limited to, project charters, detailed project plans/milestones, progress reports, activity logs and deliverables, i.e. RMP submissions. Updates/maintains assigned project related documentation as per defined in risk management processes and file structure on designated system. Provides risk management education to internal and external colleagues With oversight, participates in audits and inspections; preparing and coordinating responses; participates in inspection readiness. Acts as a SME or BPO for a Safety SOP. Manages special projects and assists with communications. Provides guidance and coaching to less experienced RMPLs, participates in initial training of newly hired RMPLs, acts as first point of contact to assist other RMPLs in issue resolution. Has the foresight and judgement to recommend and then manage external safety KOL consultations, expert working groups, and other external safety forums. Implements opportunities identified for consistency and standardization in Safety Identifies and evaluates issues and presents strategies to ensure that timelines are met or accelerated. Influences above country and local individuals responsible for Safety, Regulatory, and Medical for appropriate risk management development and implementation Qualifications
Required: Bachelors degree and 8+ years of experience or Masters degree and 7+ years of experience or Pharm.D, or Ph.D, or equivalents and 1+ years of industry experience Required: Minimum 10 years of broad and progressive pharma experience in medical, clinical or pharmacovigilance with a clear focus on drug safety risk management Required: Knowledge of global safety regulations and guidelines, or equivalent Required: Demonstrated experience in global drug safety risk management planning activities and generating RMPs Required: Demonstrated strength in analytical skills and attention to detail Required: Demonstrated strength in oral/written communication, negotiation, and interpersonal skills Required: Demonstrated organizational/project management skills Required: Familiarity with management of performance metrics Required: Significant knowledge of organization processes and matrix-based decision-making Preferred: Project management certification (PMP) and Six Sigma Certification Skills
High level analytical skills - Detail oriented, independent, and manage processes to both establish timelines and ensure timelines are met Strategic Thinking – Analyze, frame, and communicate complex issues; writing and presentation proficiency Clinical, Regulatory and Safety Expertise - Knowledge of clinical research processes, safety or regulatory requirements; knowledge of Risk Management regulations and drug development process Technical Expertise – Applies technical and line knowledge of key concepts in own discipline Scientific/Administrative Excellence - Ability to evaluate and document review and analysis of data Organizational Development – Knowledge of organizational development principles and implementation of strategies Project and Process Management – Manage multiple complex projects and cross-functional processes; budgetary management Computer applications - MS Word, Excel, PowerPoint; familiarity with department systems Matrix collaboration skills to engage global Safety colleagues and relevant stakeholders across Regulatory, Clinical, Nonclinical, Medical, and in-country teams Additional Requirements
Last date to apply: January 29, 2026 Work Location Assignment: Hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week or more as needed
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