BeiGene Senior Medical Director, Product Safety Physician Lead (Submissions) in Boston, Massachusetts
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.
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 patients
The Senior Medical Director serves as the Lead Product Safety Physician for 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
Essential Functions of the Job:
Responsible for oversight of benefit/ risk safety profile of allocated products through the product lifecycle
Leads and enhances knowledge of safety profiles for allocated products, including both BeiGene and competitor products
Identifies and leads management of safety concerns for developmental and approved BeiGene products
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, supports meeting preparations, develops and proposes review topics/ CSC agenda items
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 and insights and provides input to DMC Charters
Leads Internal Safety Monitoring Committees (SMC) meetings & supports as needed. Provides input to SMC Charters
Leads communication of CSC recommendations for labeling amendments, participates in Labeling Working Group meetings, leads and facilitates communication of Safety outcomes to relevant stakeholders
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
Develops and facilitates 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, Reviews relevant data required for response
Leads responses and contributes to formal response provided to regulatory agencies, reviews draft response, and manages approval of response
Leads the incorporation of latest updates and findings from ongoing pharmacovigilance and epidemiological analysis
Leads BeiGene safety in face-to-face regulatory meetings
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 responses
Guides 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 requested
Leads 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 and supports 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 updates
Accountable for the content of safety sections of the Development Safety Update Report (DSUR), reviews and approves
Leads 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
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 analysis
Accountable 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 trial
Accountable for the determination of safety data required for capture in CRFs during clinical trials, reviews and provides product program wide input to CRFs
Leads and facilitates 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
Developmental Product Safety Monitoring and Surveillance (Protocol Specific)
Accountable for the 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 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 report
Accountable for drafting the safety sections of the Summary of Clinical Safety and ISS
Leads 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 compounds
Leads the preparations for and attends clinical team meetings
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
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 SAE’s by system, compound, and TA to detect significant correlation/causation, develops monthly signal detection reports using internal and external data
Reviews and guides materials as part of the monthly/quarterly Signal Detection Team (SDT) review meeting
Leads safety Issue Assessment and documentation, develop determination of issue scope, execute risk assessment
Accountable for development and update summary of competitor safety profile labelling, 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, chair review meetings, identifies safety issues for escalation to SMT, determine if a safety concern needs escalation to management, facilitates closure on recommendations
Accountable for development and maintenance of updates to Product Surveillance Plans
Leads PSUR/PBRER strategy, determines content and oversight, contributes to authoring of relevant sections and review of PSURs/PBRERs
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
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
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 papers
Contributes to and facilitates 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 inspections
Trains and mentors Safety Physicians and Safety Scientists
Actively leads and maintains an environment of continuous improvement within the team and contributes to continuous improvement initiatives across GPS
Minimum Requirements – Education and Experience:
MD (or internationally recognized equivalent) plus accredited residency, with 6 + years' pharmaceutical/biotechnology industry experience in Clinical Research, Clinical Development and 4 + years' experience 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.
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
This position may have between safety physicians reporting to it depending on the program / portfolio being led. The Senior Medical Director serves as Product Safety Physician Lead for 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.
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.
Travel: Less than 10-%
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.
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