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.

The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often multi-indication) 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 of the Job:

Accountable for oversight of benefit/risk safety profile of allocated products through the product lifecycleActively leads and enhances knowledge of safety profiles for allocated products, including both BeiGene and competitor productsIdentifies and actively leads management of safety concerns for developmental and approved BeiGene productsActively leads Development and Medical Affairs product teams in the identification of, and handling of product safety concerns

Governance:

Chairs Safety Management Team (SMT) meetings for assigned products, reviews SMT Materials, develops & represents safety perspective in SMT meetingsRepresents the SMT and participates in Company Safety Committee (CSC) meetings, support meeting preparations, develop & proposes review topics/ CSC agenda itemsActively leads communication of recommendations to labeling group/other stakeholdersActively 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 ChartersActively leads Internal Safety Monitoring Committees (SMC) meetings & supports as needed. Provides input to SMC Charters

Product Labeling:

Actively leads communication of CSC recommendations for labeling amendments, participates in Labeling Working Group meetings, leads communication of Safety outcomes to relevant stakeholdersActively leads the development and maintenance of the Company Core Safety Information (CCSI), proposes edits and manages approval of amendmentsPresents the CCSI to the labeling committee, contributes viewpoint to CCDS development, and reviews company core data sheetProvides 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

Issues Management:

Leads and manages escalation of potential issues to the SMT, ensures internal notification and provides updatesLeads and develops strategy for issue management and facilitates internal approval of plansLeads 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 responsesLeads the formulation of a rapid response procedure, triage of potential issues to safety committee, executes Crisis Management response plan, reviews ongoing issue and planReviews regulatory inquiry to lead strategizing the nature of response, best course of action and determines data specifications, Reviews relevant data required for responseLeads responses and contributes to formal response provided to regulatory agencies, reviews draft response, and manages approval of responseActively leads the incorporation of latest updates and findings from ongoing pharmacovigilance and epidemiological analysisActively leads BeiGene safety in face-to-face regulatory meetingsActively leads and develops an evaluation of safety enquiries (Internal, External, HCP & consumer), leads the assignment of response drafting responsibility, determines data required for response, reviews response data & drafts response and manages approval of responsesGuides and leads 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 Functions:

Leads and develops 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 requestedLeads 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.Leads EU/International Safety Communication & Co-ordination training to BeiGene employees on product safety issues and profiles

Trial Safety Support:

Accountable for 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 leads input on product program wide safety issues, protocols, and protocol updatesAccountable for the content of safety sections of the Development Safety Update Report (DSUR), reviews and approvesAccountable for 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 assessmentActively leads and 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 analysisAccountable for 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 trialAccountable for the determination of safety data required for capture in CRFs during clinical trials, reviews and provides product program wide input to CRFsLeads the formulation safety criteria and review of study specific medical monitoring plansParticipates in investigator meetings, as needed, accountable for product safety profile and reviews, approves and updates of safety presentation content

Developmental Product Safety Monitoring and Surveillance: (Protocol Specific)

Accountable for the analysis of SAEs by system, compound and TA to detect significant correlation/ causationAccountable for output/summary report for inclusion into clinical, filing, and post-market reportsAccountable 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)

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 reportAccountable for drafting the safety sections of the Summary of Clinical Safety and ISSLeads 120-day update plans and activities

Extra-Departmental Liaison & Co-ordination:

Represents and promotes safety at the product development team as core team member, contributes to development strategy for allocated compoundsLeads the preparations for and attends clinical team meetingsActively leads contribution 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 Interfaces:

Leads GPS product co-ordination, chairs product group meetings across GPS

Pharmacovigilance:

Leads and manages safety PV processes for BeiGene and competitor productsAccountable for the development of Product Safety Strategy and the writing and maintenance of the Safety Surveillance PlansLeads and 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 dataReviews and guides materials as part of the monthly/quarterly Signal Detection Team (SDT) review meetingActively leads safety Issue Assessment and documentation, develop determination of issue scope, execute risk assessmentAccountable for development and update summary of competitor safety profile labelling, FOI, and issuesAccountable for development and maintenance of product safety profiles and develops Events of InterestPresents 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 recommendationsAccountable for development and maintenance of updates to Product Surveillance PlansActively leads PSUR/PBRER strategy, determines content and oversight, contributes to authoring of relevant sections and review of PSURs/PBRERsActively 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 HasActively 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 updateActively leads the development of safety Post Approval Commitments (PAC) proposals, facilitates the design of PAC proposed safety study, executes PAC studiesLeads and manages the definition of events of interest, defines case follow-up needsAccountable for development and implementation of product launch plansAccountable for development of a publication plan, contributes to draft papersContributes to and promotes the development of a global Pharmacoepidemiology (PE) strategy

Compliance, Standards, Training & Project Management

Actively leads the evaluation of current processes and assesses alignment with regulatory expectations, guidelines, mandates for regulatory inspectionsTrains and mentors Safety Physicians and Safety ScientistsActively leads and maintains an environment of continuous improvement within the team and contributes to continuous improvement initiatives across GPS

Supervisory Responsibilities:

This position may have safety physicians reporting to it depending on the program / portfolio being led. The Executive Medical Director serves as Product Safety Physician Lead for multiple or large complex strategically important developmental programs. Works closely with the other Safety Science and Epidemiology Physicians and Safety Scientists as part of a flexible 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

Education Required:

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

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity

Salary Range: $310,200.00 - $390,200.00 annually

BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene 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.

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.