Executive Medical Director, Safety Franchise Area Lead

BeiGene

2d • $328,000 - $408,000

About The Position

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. Franchise/Disease Area Leadership 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 Molecule-specific Contributions Governance 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 Issues Management Lead and manage escalation of potential issues to safety governance (SMT/CSC) or appropriate cross-functional governance, executes Crisis Management response plan, ensure internal notification and provide updates Lead safety issue/regulatory inquiry management, formulation of response strategy, comprehensive review and contextualization of data from all sources (e.g., CT, PM, non-clinical, literature, epidemiology, competitor safety profile labelling, etc.), risk management, and closure of recommendations, including the drafting, review, and approval of analysis/response documents Actively lead safety in regulatory interactions Guide and lead medical review of SAEs, provide immediate input to escalated cases, and determine and execute further escalation within BeOne as required per applicable processes Commercialization Support and Liaison with Other Functions Lead the development and execution of safety differentiation strategies for BeOne products, provide input into TPP, publications strategy (including review of abstract, manuscripts, and speaker presentations), contribute safety expertise to evaluation of potential in-licensing opportunities as requested Lead product liaison for BeOne functions (Legal, Bus Dev, Operations, Marketing, etc.), execute appropriate communication of safety data and interpretation to BeOne and external parties, globally, facilitates communication with country office medical directors as required Provide training to BeOne employees on product safety profiles/issues Trial Safety Support Accountable for safety data and responsible for providing guidance on safety endpoints, safety-related inclusion and exclusion criteria, schedule of assessment, and trial data capture; lead study and program-level data review and appropriate actions to address safety findings Accountable for defining the safety plan in protocols, the safety sections of the IB, ICF, and updates to trial documentation based on new safety data Actively develop the specification of anticipated safety-related statistical analyses for clinical trials, ensuring inclusion in the SAP with appropriate safety endpoints, analysis populations, and methodologies to support regulatory and program-level safety assessments Define safety data requirement and develop safety section of the clinical data management plan, supports the review and update of data management plan based on updates to integrated safety viewpoint during trial Accountable for the determination of safety data required for capture in CRFs during clinical trials, review and provide input to CRFs Lead the formulation safety criteria and review of study specific medical monitoring plans Accountable for the content of safety sections of the Development Safety Update Report (DSUR), including review and approval Participate in investigator meetings as needed, taking accountability for the product safety profile and all safety presentation content Developmental and Postmarketing Product Safety Monitoring and Surveillance Accountable for the development of Signal Detection Plan and analysis of SAEs by system, compound and TA to detect significant correlation/ causation Accountable for daily, weekly, and monthly review of SAEs and abnormal labs, protocol specific review of aggregate SAEs and specific analysis of aggregate CTDB (AE tables, shift tables, listings) Reviews and guides interpretation of safety findings as part of the monthly/quarterly signal detection review meeting and accountable for signal detection reports using internal and external data Accountable for output/summary report for inclusion into clinical, filing, and post-market reports Submission Filing Safety Support Proactively, reviews and interprets study safety data, supports Clinical Study Report narrative generation, leads the interpretation-based safety sections of reports, reviews draft report Accountable for drafting the safety sections of the Summary of Clinical Safety and ISS Leads 120-day update plans and activities Product Labeling Lead communication of CSC recommendations for labeling amendments, participates in Labeling Working Group meetings, leads communication of Safety outcomes to relevant stakeholders Contribute safety strategy and content for the development and update of Company core data sheet (CCDS) Provide safety insights to the development of Package Insert and Labeling Updates, develops labeling update impact summaries for use by RA, develops labeling prose text updates, based on internal aggregated reports Postmarketing Pharmacovigilance Actively leads PSUR/PBRER strategy, determines content and oversight, contributes to authoring of relevant sections and review of PSURs/PBRERs Actively leads the scope, strategy, and content of responses to HA assessment reports, contributes to authoring of relevant sections, reviews and manages approval of PSUR/PBRER responses to HAs Actively leads the definition of Risk Management Plan (RMP) drivers & content, reviews core RMP & local RMPs (or REMS) and leads execution of RMP elements, documentation of evidence of RMP execution, evaluates potential risks for evidence of risk confirmation and leads recommendations for RMP/REMS update Actively leads the development of safety Post Approval Commitments (PAC) proposals, facilitates the design of PAC proposed safety study, executes PAC studies Leads and manages the definition of events of interest, defines case follow-up needs Accountable for development and implementation of product launch plans Accountable for development of a publication plan, contributes to draft manuscripts/abstracts Contributes to and promotes the development of a global Pharmacoepidemiology (PE) strategy Process Excellence Actively leads the evaluation of current processes and assesses alignment with regulatory expectations, guidelines, mandates for regulatory inspections Actively leads and maintains an environment of continuous improvement within the team and contributes to continuous improvement initiatives across GPS

Requirements

• Manage one or more franchises, including direct supervision of the Product Safety Physician Leads or other Safety Science team members supporting the respective franchise/disease area.
• Intermediate knowledge working with a safety database for retrieval of safety information
• Advanced knowledge of MedDRA
• MS Office Suite: Advanced application capability with Excel, PowerPoint, and Word. Familiarity with data mining tools and exploratory analyses tools such as Spotfire.
• Prior matrix management team experience
• Prior experience as a product safety physician
• Pharmaceutical product development experience, including individual study design and filing plans
• Experienced in global regulatory requirements for pharmacovigilance
• Appropriate experience with Regulatory Agency and KOL interactions
• MD (or internationally recognized equivalent) plus accredited residency, with 10+ years pharmaceutical/biotechnology industry experience in Clinical Research, Clinical Development with at least 6 years in pharmacovigilance.

Nice To Haves

• Accredited fellowship with 1-year clinical experience with patients in a relevant therapeutic area specialty, with significant knowledge of general medicine is preferred

Responsibilities

• Franchise/Disease Area Leadership 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.
• 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
• Lead and manage escalation of potential issues to safety governance (SMT/CSC) or appropriate cross-functional governance, executes Crisis Management response plan, ensure internal notification and provide updates
• Lead safety issue/regulatory inquiry management, formulation of response strategy, comprehensive review and contextualization of data from all sources (e.g., CT, PM, non-clinical, literature, epidemiology, competitor safety profile labelling, etc.), risk management, and closure of recommendations, including the drafting, review, and approval of analysis/response documents
• Actively lead safety in regulatory interactions
• Guide and lead medical review of SAEs, provide immediate input to escalated cases, and determine and execute further escalation within BeOne as required per applicable processes
• Lead the development and execution of safety differentiation strategies for BeOne products, provide input into TPP, publications strategy (including review of abstract, manuscripts, and speaker presentations), contribute safety expertise to evaluation of potential in-licensing opportunities as requested
• Lead product liaison for BeOne functions (Legal, Bus Dev, Operations, Marketing, etc.), execute appropriate communication of safety data and interpretation to BeOne and external parties, globally, facilitates communication with country office medical directors as required
• Provide training to BeOne employees on product safety profiles/issues
• Accountable for safety data and responsible for providing guidance on safety endpoints, safety-related inclusion and exclusion criteria, schedule of assessment, and trial data capture; lead study and program-level data review and appropriate actions to address safety findings
• Accountable for defining the safety plan in protocols, the safety sections of the IB, ICF, and updates to trial documentation based on new safety data
• Actively develop the specification of anticipated safety-related statistical analyses for clinical trials, ensuring inclusion in the SAP with appropriate safety endpoints, analysis populations, and methodologies to support regulatory and program-level safety assessments
• Define safety data requirement and develop safety section of the clinical data management plan, supports the review and update of data management plan based on updates to integrated safety viewpoint during trial
• Accountable for the determination of safety data required for capture in CRFs during clinical trials, review and provide input to CRFs
• Lead the formulation safety criteria and review of study specific medical monitoring plans
• Accountable for the content of safety sections of the Development Safety Update Report (DSUR), including review and approval
• Participate in investigator meetings as needed, taking accountability for the product safety profile and all safety presentation content
• Accountable for the development of Signal Detection Plan and analysis of SAEs by system, compound and TA to detect significant correlation/ causation
• Accountable for daily, weekly, and monthly review of SAEs and abnormal labs, protocol specific review of aggregate SAEs and specific analysis of aggregate CTDB (AE tables, shift tables, listings)
• Reviews and guides interpretation of safety findings as part of the monthly/quarterly signal detection review meeting and accountable for signal detection reports using internal and external data
• Accountable for output/summary report for inclusion into clinical, filing, and post-market reports
• Proactively, reviews and interprets study safety data, supports Clinical Study Report narrative generation, leads the interpretation-based safety sections of reports, reviews draft report
• Accountable for drafting the safety sections of the Summary of Clinical Safety and ISS
• Leads 120-day update plans and activities
• Lead communication of CSC recommendations for labeling amendments, participates in Labeling Working Group meetings, leads communication of Safety outcomes to relevant stakeholders
• Contribute safety strategy and content for the development and update of Company core data sheet (CCDS)
• Provide safety insights to the development of Package Insert and Labeling Updates, develops labeling update impact summaries for use by RA, develops labeling prose text updates, based on internal aggregated reports
• Actively leads PSUR/PBRER strategy, determines content and oversight, contributes to authoring of relevant sections and review of PSURs/PBRERs
• Actively leads the scope, strategy, and content of responses to HA assessment reports, contributes to authoring of relevant sections, reviews and manages approval of PSUR/PBRER responses to HAs
• Actively leads the definition of Risk Management Plan (RMP) drivers & content, reviews core RMP & local RMPs (or REMS) and leads execution of RMP elements, documentation of evidence of RMP execution, evaluates potential risks for evidence of risk confirmation and leads recommendations for RMP/REMS update
• Actively leads the development of safety Post Approval Commitments (PAC) proposals, facilitates the design of PAC proposed safety study, executes PAC studies
• Leads and manages the definition of events of interest, defines case follow-up needs
• Accountable for development and implementation of product launch plans
• Accountable for development of a publication plan, contributes to draft manuscripts/abstracts
• Contributes to and promotes the development of a global Pharmacoepidemiology (PE) strategy
• Actively leads the evaluation of current processes and assesses alignment with regulatory expectations, guidelines, mandates for regulatory inspections
• Actively leads and maintains an environment of continuous improvement within the team and contributes to continuous improvement initiatives across GPS

Benefits

• All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.
• The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree