Director, Risk Management Product Lead

Role Summary

Provide strategic expertise to product teams and drive the execution of Risk Management activities across business units to embed innovative and efficient risk management strategies that enhance patient safety. Collaborate on developing the next generation Risk Management Center of Excellence and uphold best practices in risk management planning, risk communication, and benefit/risk assessment methodologies. Lead and influence cross-functional safety activities, ensuring alignment with regulatory requirements and company objectives.

Responsibilities

• Develop and evolve best practices in risk management planning, risk communication, risk minimization, and benefit/risk assessment methodologies in collaboration with the RMCoE Head.
• Provide strategic guidance for risk management planning to Safety Surveillance & Risk Management (SSRM) and support development and implementation of RMP initiatives.
• Act as the primary interface between RAM and the business units for oversight of RMP commitments and provide status updates to the RMC.
• Lead PRMS using effective leadership and process management; manage agendas, meeting minutes, action tracking, and external expert engagement.
• Manage supplier performance relative to SOW and coordinate day-to-day supplier communications.
• Provide regular reporting on RMP milestones and KPIs via dashboards; maintain project planning documentation and RMP submissions.
• Maintain project-related documentation and provide risk management education to internal and external colleagues.
• Participate in audits/inspections, coordinate responses, and contribute to inspection readiness; serve as SME or BPO for Safety SOPs.
• Manage special projects, assist with communications, and provide guidance/coaching to RMPLs; mentor new hires and assist with issue resolution.
• Engage external safety forums and KOLs as appropriate; advance consistency and standardization in Safety practices.
• Identify issues, develop strategies, and ensure timelines are met; influence safety, regulatory, and medical stakeholders for risk management implementation.

Qualifications

• Required: Bachelor’s degree and 8+ years of experience, or Master’s degree and 7+ years of experience, or Pharm.D/Ph.D/equivalents with 1+ years of industry experience.
• Required: Minimum 10 years of broad pharma experience in medical, clinical, or pharmacovigilance with a focus on drug safety risk management.
• Required: Knowledge of global safety regulations/guidelines; demonstrated experience in global drug safety risk management planning and generating RMPs.
• Required: Strong analytical skills, attention to detail, and excellent oral/written communication, negotiation, and interpersonal skills.
• Required: Demonstrated organizational/project management skills and familiarity with management of performance metrics; experience with matrix-based decision-making.
• Required: Project management certification (PMP) and Six Sigma certification preferred.
• Preferred: Advanced degree (Pharm.D/Ph.D or equivalents).

Skills

• High level analytical skills; detail-oriented and able to manage processes to meet timelines; excellent organizational skills.
• Strategic thinking; ability to analyze and communicate complex issues, including writing and presentations.
• Clinical, Regulatory, and Safety expertise; knowledge of risk management regulations and drug development process.
• Technical expertise within the discipline; ability to act as a technical resource.
• Scientific/Administrative excellence; ability to evaluate and document data analyses.
• Organizational development; experience developing and implementing organizational strategies.
• Project and process management; ability to manage multiple complex projects and meet deadlines; budgetary management experience.
• Computer proficiency (Word, Excel, PowerPoint) and familiarity with department systems.
• Ability to build collaborative global safety partnerships with SSRM, Regulatory, Clinical, Nonclinical, Medical, and in-country teams.

Additional Requirements

• Hybrid work arrangement requiring living within commuting distance and onsite presence 2.5 days per week or more as needed.