Executive Medical Director, Safety Franchise Area Lead

Overview

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

The Executive Medical Director, Safety Franchise Area Lead will lead and oversee a team of Product Safety Physician Leads within the assigned franchise or disease area. This role is responsible for establishing strategic safety direction and ensuring consistent, high-quality execution of safety activities across all assigned molecules and medicines within the franchise.

The Safety Franchise Area Lead has direct accountability for safety oversight of all compounds within the franchise or disease area and is responsible for shaping portfolio-level safety strategies, execution, and stakeholder engagement. This includes leading routine franchise- or disease area-wide safety activities, planning, and decision-making that require cross-functional coordination across multiple molecules and development programs. The Safety Franchise Area Lead represents Safety Science at the franchise committee and applicable governance forums, providing expert input on safety considerations to inform portfolio and development strategies.

In addition, this role is expected to engage hands-on at the individual program level as needed and may directly serve as the Product Safety Lead for (a) specific program(s), providing direct safety leadership, expert guidance, and decision-making for specific programs through appropriate governance processes.

• Act as a safety technical reviewer for all relevant safety documents or clinical documents with safety content prepared by Product Safety Leads and supporting teams, providing strategic and medical leadership input. This includes but not limited to safety strategies and plans;
  Target Early Profile (TEP)/Target Product Profile (TPP), safety content of protocols;
  Investigator’s Brochure;
  Informed Consent Form;
  Safety Analysis Plan; clinical study reports; CCDS/product labels;
  Risk Management Plans;
  Summary of Clinical Safety and ISS; aggregate safety reports;
  Health Authority Request for Information/Queries; relevant safety communications (e.g., DIL/DHPC/DHCP letter), and scientific publications
• Evaluate the appropriateness of strategies to address safety issues and/or enquiries from internal and external stakeholders, review supporting data and drafted content, and manage communication or escalation in alignment with BeOne processes and standards
• Ensure a robust and independent safety position is established for all assets supported by the franchise/disease area, and that the impact of safety findings is systematically assessed through appropriate governance processes and stakeholder engagement with clear and appropriate medical interpretation of safety information
• Facilitate communication and functional alignment with the Safety Leadership Team and key functional partners
• Provide matrix leadership and drive consistent application of franchise-wide operational standards to maintain a robust safety support framework across all molecules and/or programs
• Lead routine franchise-level resource planning and utilization to ensure appropriate prioritization and coverage in line with business priorities as a direct/matrix manager
• Plan and coordinate the transition of assets across all phases of development and through the full product lifecycle, ensuring continuity of safety strategy, ongoing risk assessment, and consistent safety oversight from early development through post-marketing activities
• Accountable for overseeing and guiding the performance of Product Safety Leads, to ensure consistent delivery aligned with business strategies, required behaviors, quality standards, and defined processes
• Provide matrix leadership, mentoring, and strategic direction to Safety Science team members supporting the franchise/disease area

• Lead program-specific Safety Management Team meeting and/or provide oversight of all compounds within the franchise/disease area, ensuring accurate medical contextualization of safety data, quality presentation, and appropriate recommendation of actions across molecules/programs at SMT and Company Safety Committee (CSC) meetings
• Lead and/or oversee the communication of governance recommendations to clinical development/labeling /quality/other relevant stakeholders. Guide the development of content to address required actions, including the strategic implications and implementation across applicable molecules and programs
• Accountable for safety data content and provide strategic insights and medical leadership to Data Monitoring Committees (DMC)/Safety Monitoring Committees (SMC), including input on charters and participation in meetings as required across all molecules/programs within the franchise