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BeiGene 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.Company Overview:BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 7,700 employees across China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patientsGeneral Description:The Associate Medical Director supports the Product Safety Physician Lead for 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.Essential Functions:Supports the oversight of benefit/ risk safety profile of allocated products through the product lifecycle
Maintains and enhances knowledge of safety profiles for allocated products, including both BeiGene and competitor products
Identifies and manages safety concerns for developmental and approved BeiGene products
Assists Development and Medical Affairs product teams in the identification of, and handling of, product safety concerns
GovernanceSupports the Safety Management Team (SMT) meetings for assigned products, reviews SMT Materials
Represents the SMT and participates in Company Safety Committee (CSC) meetings, as needed Supports meeting preparations, Develop & proposes review topics/ CSC agenda items
Facilitates communication of recommendations to labeling group/other stakeholders
Participates in meetings as required in External Safety Monitoring Committees (DMC) meetings through provision and review of safety data, and provides input to DMC Charters
Participates in Internal Safety Monitoring Committees (SMC) meetings & supports as needed. Provides input to SMC Charters
Product LabelingSupports the communication of CSC recommendations for labeling amendments, participates in Labeling Working Group meetings, facilitates communication of Safety outcomes to relevant stakeholders
Minimum Requirements – Education and Experience:MD (or internationally recognized equivalent) with 1+ years pharmaceutical/biotechnology industry experience in Clinical Research and/or Clinical Development.
1+ years in pharmacovigilance
Accredited residency or fellowship with 1-year clinical experience with patients in a relevant therapeutic area specialty, with significant knowledge of general medicine is preferred.
Supports the development and maintenance of the Company Core Safety Information (CCSI), proposes edits and facilitates approval of amendments
Delivers the CCSI to the labeling committee, contributes viewpoint to CCDS development, and reviews company core data sheet
Contributes 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
Issues ManagementEscalates potential issues to the SMT, ensures internal notification and provides updates
Supports development of the strategy for issue management and facilitates internal approval of plans
Supports the review of issue data and closure on recommendations, supports the drafting of an issue response document, reviews, and manages approval of issue response documentation and responses.
Contributes to 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 strategize the nature of response, best course of action and determines data specifications, Reviews relevant data required for response
Supports the incorporation of latest updates and findings from ongoing pharmacovigilance and epidemiological analysis
Drafts responses and contribute to formal response provided to regulatory agencies, reviews draft response, and manages approval of response
Supports BeiGene representatives prepare for face-to-face regulatory meetings
Develops an evaluation of safety enquiries (Internal, External, HCP and consumer), contributes to the assignment of response drafting responsibility, determines data required for response, reviews response data & drafts response and manages approval of responses
Supports medical review of SAEs and provides immediate input to escalated reports, determines, and executes further escalation within BeiGene as needed
Commercialization Support and Liaison with Other FunctionsSupports development of strategic plans for safety differentiation of BeiGene products, provides training to BeiGene employees on product safety profiles/issues, provides input into commercial publications strategy, reviews publications, including abstracts, manuscripts, and speaker presentations, provides input for potential in-licensing opportunities as requested
Provides product liaison for BeiGene functions (Legal, Bus Dev, Operations, Marketing, etc.), executes appropriate communication of safety data and interpretation to BeiGene and external parties, globally, facilitates communication with country office medical directors as required
Supports EU/International Safety Communication & Coordination training to BeiGene employees on product safety issues and profiles
Trial Safety SupportProvides safety data, reviews, and provides advice on Safety Endpoints, safety related inclusion and exclusion criteria data to capture during trial, key review activities and timing, reviews and provides input on product program wide safety issues, protocols, and protocol updates
Contributes to the writing of the Development Safety Update Report (DSUR), reviews, and approves
Supports the development and maintenance of RSIs, contributes to the safety sections of the IB, ICF and updates and manages any needs to reconsent subjects in ongoing trials based on emergent safety data assessment
Develops expectations of expected, anticipated statistical analyses to run over trial for the SAP and provides product program wide input on safety statistical elements required for analysis
Contributes to data requirement recommendations and safety section for clinical data management plan for capture during clinical trials, supports the review and update of data management plan based on updates to integrated safety viewpoint during trial
Contributes to the determination of safety data required for capture in CRFs during clinical trials, Reviews and provides product program wide input to CRFs
Supports the formulation safety criteria and review of study specific medical monitoring plans
Participates in investigator meetings & presents product safety profile and reviews, approves and updates of safety presentation content
Developmental Product Safety Monitoring and Surveillance (Protocol Specific)Contributes to the analysis of SAEs by system, compound, and TA to detect significant correlation/ causation
Develops output/summary report for inclusion into clinical, filing, and post-market reports
Executes 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)
Submission Filing Safety SupportReviews and interprets study safety data, support Clinical Study Report narrative generation, drafts the interpretation-based safety sections of reports, reviews draft report
Accountable for drafting the safety sections of the Summary of Clinical Safety and ISS
Contributes to 120-day update plans and activities
Extra-Departmental Liaison & Co-ordinationRepresents safety at the product development team, as core team member contributes to development strategy for allocated compounds
Contributes to the preparations for and attends clinical team meetings
Contributes to development of differentiation of BeiGene products, provides training guidance to marketing training materials, reviews, and contributes to marketing materials
Internal Global Patient Safety Department Development InterfacesSupports the facilitation of GPS product co-ordination, and chairperson of product group meetings across GPS
PharmacovigilanceCreates 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
Executes proactive, ongoing analysis of SAEs by system, compound, and TA to detect significant correlation/causation, develops monthly signal detection reports using internal and external data
Reviews materials as part of the monthly/quarterly Signal Detection Team (SDT) review meeting
Conducts Safety Issue Assessment and documentation, develop determination of issue scope, execute risk assessment
Develops and updates summary of competitor safety profile labelling, FOI, and issues
Develops and maintains product safety profiles and develops Events of Interest
Presents data at scheduled and ad hoc product safety reviews, chair review meetings, identifies safety issues for escalation to SMT, determine if a safety concern needs escalation to management, facilitates closure on recommendations
Develops and updates Product Surveillance Plans
Provides PSUR/PBRER strategy, determines content and oversight, contributes to authoring of relevant sections and review of PSURs/PBRERs
Determines 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
Contributes to the definition of Risk Management Plan (RMP) drivers & content, reviews core RMP & local RMPs (or REMS) and ensures execution of RMP elements, documents evidence of RMP execution, evaluates potential risks for evidence of risk confirmation and makes recommendations for RMP/REMS update
Contributes to the development of safety Post Approval Commitments (PAC) proposals, facilitates the design of PAC proposed safety study, executes PAC studies
Manages the definition of events of interest, defines case follow-up needs
Develops and implement product launch plans
Develops a publication plan, contributes to draft papers
Contributes to the development of a global Pharmacoepidemiology (PE) strategy
Compliance, Standards, Training & Project ManagementSupports the evaluation of current processes and assesses alignment with regulatory expectations, guidelines, mandates for regulatory inspections
Supports an environment of continuous improvement within the team and contributes to continuous improvement initiatives across GPS
Other Qualifications: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 is a plus, but not required.
Appropriate experience with Regulatory Agency and KOL interactions is a plus, but not required.
Supervisory Responsibilities:The position has no direct reports. The Associate Medical Director supports the Product Safety Physician Lead for developmental programs. Works closely with the other Safety Science and Epidemiology Physicians and Safety Scientists as part of a matrix team to conduct robust safety assessments and safety risk management activities, based on ICH standards for developmental product safety upon which marketed product safety surveillance may be based.Travel:Less than 10%Computer Skills: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.Competencies:Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.Project Management - Communicates changes and progress; Completes projects on time and budget.We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
