Executive Director, Safety Franchise Area Lead

BeiGene

9d•$285,800 - $365,800

About The Position

BeOne is seeking an experienced professional to join its growing team as the Executive Director, Safety Franchise Area Lead. This role is responsible for leading and overseeing a team of Product Safety Physician Leads within a specific franchise or disease area. The position involves establishing strategic safety direction, ensuring high-quality execution of safety activities across all assigned molecules and medicines, and shaping portfolio-level safety strategies. The Safety Franchise Area Lead will represent Safety Science at franchise committees and governance forums, providing expert input on safety considerations to inform portfolio and development strategies. The role may also involve hands-on engagement at the individual program level, potentially serving as the Product Safety Lead for specific programs.

Requirements

PhD or PharmD with 10+ years pharmaceutical/biotechnology industry experience in Clinical Research, Clinical Development with at least 8+ years in pharmacovigilance.
Prior experience as a product safety leader.
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.
Intermediate knowledge working with a safety database for retrieval of safety information.
Advanced knowledge of MedDRA.
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.

Nice To Haves

Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity

Responsibilities

Lead and oversee a team of Product Safety Physician Leads within the assigned franchise or disease area.
Establish strategic safety direction and ensure consistent, high-quality execution of safety activities across all assigned molecules and medicines.
Have direct accountability for safety oversight of all compounds within the franchise or disease area.
Shape portfolio-level safety strategies, execution, and stakeholder engagement.
Lead routine franchise- or disease area-wide safety activities, planning, and decision-making that require cross-functional coordination.
Represent Safety Science at the franchise committee and applicable governance forums, providing expert input on safety considerations.
Engage hands-on at the individual program level as needed and may directly serve as the Product Safety Lead for specific program(s).
Act as a safety technical reviewer for all relevant safety documents or clinical documents with safety content.
Evaluate the appropriateness of strategies to address safety issues and/or enquiries from internal and external stakeholders.
Ensure a robust and independent safety position is established for all assets supported by the franchise/disease area.
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.
Lead routine franchise-level resource planning and utilization.
Plan and coordinate the transition of assets across all phases of development and through the full product lifecycle.
Oversee and guide the performance of Product Safety Leads.
Provide matrix leadership, mentoring, and strategic direction to Safety Science team members supporting the franchise/disease area.
Lead program-specific Safety Management Team meetings and/or provide oversight of all compounds within the franchise/disease area.
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.
Accountable for safety data content and provide strategic insights and medical leadership to Data Monitoring Committees (DMC)/Safety Monitoring Committees (SMC).
Lead and manage escalation of potential issues to safety governance or appropriate cross-functional governance.
Lead safety issue/regulatory inquiry management, formulation of response strategy, comprehensive review and contextualization of data from all sources.
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.
Lead the development and execution of safety differentiation strategies for BeOne products.
Provide input into TPP, publications strategy.
Contribute safety expertise to evaluation of potential in-licensing opportunities.
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.
Facilitate 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.
Actively develop the specification of anticipated safety-related statistical analyses for clinical trials.
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.
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).
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.
Reviews and guides interpretation of safety findings as part of the monthly/quarterly signal detection review meeting and accountable for signal detection reports.
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.