Junto HLS has been engaged by Leadership at a Top 20 pharma to recruit a Senior Director, Risk Management.

Position Overview:

• Required – Advanced degree

Excellence in Risk Management Strategy and Benefit/Risk

• Develop and execute the overall vision and strategy for Risk Management and Benefit/Risk in Global Patient Safety (GPS) and across the larger organization
• Provide leadership and expertise to ensure consistency of product RM and B/R assessment globally across all therapeutic areas
• Support the Risk Management Leads (RMLs) in their activities to provide strategic leadership within GPS and the cross-functional product teams
• Provide subject matter expertise and/or support RML subject matter expertise provision during inspections
• Educate members of GPS, cross-functional product teams, and the larger organization on the disciplines of Risk Management, Benefit/Risk Assessment, and the changing regulatory environment around them
• Contribute to B/R discussions with GPS senior management as indicated
• Facilitate links with regulatory agency advisory groups, academic centers, and advocacy organizations to ensure cutting edge knowledge and application of RM and B/R regulations and best practices

Risk Management and B/R Processes

• Provides general oversight of RMP development and submission tracking globally across therapeutic areas
• Provides general oversight of the assessment, development, validation and the implementation of required additional risk minimization measures globally across therapeutic areas
• Accountable for all RM and B/R processes to ensure they reflect current regulatory trends and best practices; facilitate the update of SOPs or other functional documents as needed
• Engage with partner global functions (e.g. Regulatory Affairs, Clinical Science/Research) to ensure alignment of global processes and minimize duplication
• Work with the Risk Management Scientist in his/her efforts to provide maximal operational support to the Risk Management team
• Understand signal detection processes and help support training in signal detection to GPS and other global functions
• Engage with vendors and external experts supporting RM and B/R activities

Culture/Environment

• Dedicated expertise and time to provide strong leadership and management to the RM and B/R team members in a manner that promotes their growth and development
• Establish strong presence of the RM and B/R group in GPS and in the larger organization
• Oversee and delegate the RM and B/R workload among the RM and B/R team

Location(s):

• Greater Boston, MA

If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.