Executive Medical Director, Product Safety Physician Lead

Role Summary

The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs and creates and maintains a single interpretation of global safety data for developmental and marketed products. With the support of Safety Physicians and Safety Scientists identifies and manages the documentation and communication of safety concerns and together with teams engaged in BeiGene sponsored studies, ensures the safety of patients.

Responsibilities

• Accountable for oversight of benefit/risk safety profile of allocated products through the product lifecycle
• Actively leads and enhances knowledge of safety profiles for allocated products, including both BeiGene and competitor products
• Identifies and actively leads management of safety concerns for developmental and approved BeiGene products
• Actively leads Development and Medical Affairs product teams in the identification of, and handling of product safety concerns
• Chairs Safety Management Team (SMT) meetings for assigned products, reviews SMT Materials, develops & represents safety perspective in SMT meetings
• Represents the SMT and participates in Company Safety Committee (CSC) meetings, support meeting preparations, develop & proposes review topics/ CSC agenda items
• Actively leads communication of recommendations to labeling group/other stakeholders
• Actively participates in meetings as required in External Safety Monitoring Committees (DMC) meetings through provision and review of safety data, insights and leadership and provides input to DMC Charters
• Actively leads Internal Safety Monitoring Committees (SMC) meetings & supports as needed. Provides input to SMC Charters
• Actively leads communication of CSC recommendations for labeling amendments, participates in Labeling Working Group meetings, leads communication of Safety outcomes to relevant stakeholders
• Actively leads the development and maintenance of the Company Core Safety Information (CCSI), proposes edits and manages approval of amendments
• Presents the CCSI to the labeling committee, contributes viewpoint to CCDS development, and reviews company core data sheet
• Provides safety insights to 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
• Leads and manages escalation of potential issues to the SMT, ensures internal notification and provides updates
• Leads and develops strategy for issue management and facilitates internal approval of plans
• Leads the review of issue data and closure on recommendations, leads the drafting of an issue response document, reviews and manages approval of issue response documentation and responses
• Leads the formulation of a rapid response procedure, triage of potential issues to safety committee, executes Crisis Management response plan, reviews ongoing issue and plan
• Reviews regulatory inquiry to lead strategizing the nature of response, best course of action and determines data specifications
• Leads responses and contributes to formal response provided to regulatory agencies, reviews draft response, and manages approval of response
• Actively leads the incorporation of latest updates and findings from ongoing pharmacovigilance and epidemiological analysis
• Actively leads BeiGene safety in face-to-face regulatory meetings
• Actively leads and develops an evaluation of safety enquiries, leads the assignment of response drafting responsibility, determines data required for response, reviews response data and drafts response and manages approval of responses
• Guides and leads medical review of SAEs and provides input to escalated reports
• Leads and develops strategic plans for safety differentiation of BeiGene products, provides training to BeiGene employees on product safety profiles/issues
• Leads product liaison for BeiGene functions, communicates safety data and interpretation globally
• Leads EU/International Safety Communication & Co-ordination training to BeiGene employees on product safety issues and profiles
• Accountable for safety data, reviews and provides advice on Safety Endpoints, inclusion/exclusion criteria data to capture during trial
• Accountable for the content of safety sections of the Development Safety Update Report (DSUR)
• Accountable for development and maintenance of RSIs, contributes to the safety sections of the IB, ICF and updates
• Actively leads and develops expectations of expected statistical analyses to run over trial for the SAP
• Accountable for data requirement recommendations and safety section for clinical data management plan for capture during clinical trials
• Accountable for the determination of safety data required for capture in CRFs during clinical trials
• Leads the formulation safety criteria and review of study specific medical monitoring plans
• Participates in investigator meetings, as needed, accountable for product safety profile and reviews, approves and updates of safety presentation content
• Accountable for analysis of SAEs by system, compound and TA to detect significant correlation/ causation
• Accountable for output/summary report for inclusion into clinical, filing, and post-market reports
• Accountable for daily, weekly, and monthly review of SAEs and abnormal labs, protocol specific review of aggregate SAEs
• Proactively reviews and interprets study safety data, supports Clinical Study Report narrative generation, leads interpretation-based safety sections of reports
• Accountable for drafting the safety sections of the Summary of Clinical Safety and ISS
• Leads 120-day update plans and activities
• Represents and promotes safety at the product development team as core team member
• Leads preparations for and attends clinical team meetings
• Leads the development of differentiation of BeiGene products, provides training guidance to marketing training materials
• Leads GPS product co-ordination, chairs product group meetings across GPS
• Leads and manages safety PV processes for BeiGene and competitor products
• Accountable for the development of Product Safety Strategy and the writing and maintenance of the Safety Surveillance Plans
• Leads and executes proactive ongoing analysis of SAEs by system, compound, and TA to detect significant correlation/causation
• Reviews and guides materials as part of the SDT review meeting
• Actively leads safety Issue Assessment and documentation, develop determination of issue scope, execute risk assessment
• Accountable for development and update summary of competitor safety profile labeling, FOI, and issues
• Accountable for development and maintenance of product safety profiles and develops Events of Interest
• Presents data at scheduled and ad hoc product safety reviews, chairs review meetings, identifies safety issues for escalation
• Accountable for development and maintenance of updates to Product Surveillance Plans
• Actively leads PSUR/PBRER strategy, determines content and oversight, contributes to authoring PSURs/PBRERs
• Actively leads scope, strategy, and content of responses to HA assessment reports, contributes to authoring sections, reviews and manages approval of PSUR/PBRER responses
• Actively leads the definition of Risk Management Plan (RMP) drivers and content, reviews core RMP and local RMPs and leads execution of RMP elements
• Actively leads development of safety Post Approval Commitments (PAC) proposals and 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 papers
• Contributes to and promotes the development of a global Pharmacoepidemiology (PE) strategy

Qualifications

• MD (or internationally recognized equivalent) with 10+ years in the pharmaceutical/biotechnology industry in Clinical Research/Development, with at least 6 years in pharmacovigilance
• Accredited fellowship with 1-year clinical experience in a relevant therapeutic area is preferred

Education

• MD (or internationally recognized equivalent) plus accredited residency

Skills

• Safety risk management
• Pharmacovigilance and safety data interpretation
• Regulatory communications and labeling coordination
• Cross-functional leadership and senior stakeholder engagement
• Data analysis and safety reporting (DSUR/PSUR/PBRER)
• Strategic planning for product safety differentiation
• Crisis management and issue escalation

Additional Requirements

• None specified beyond role responsibilities; no travel or physical demands were listed as essential in the provided description.