Senior Medical Director, Product Safety Physician Lead

BeiGene

1d•$298,200 - $368,200•Remote

About The Position

The Senior 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. 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 BeOne sponsored studies, ensures the safety of patients.

Requirements

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 safety in Phase 1 and Phase 2
Accredited fellowship with 1-year clinical experience with patients in a relevant therapeutic area specialty, with significant knowledge of general medicine is preferred.
Experience in oncology in the preapproval space 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
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.

Nice To Haves

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

Responsibilities

Accountable for oversight of benefit/risk safety profile of allocated products through the product life cycle with a principle focus on early development
Actively leads and enhances knowledge of safety profiles for allocated products, including both BeOne and competitor products
Identifies and actively leads management of safety concerns for developmental and approved BeOne products
Actively leads Development and, as required, 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 (e.g., dose escalation safety meeting) & supports as needed. Provides input to safety 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, 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
Actively leads the incorporation of latest updates and findings from ongoing pharmacovigilance and epidemiological analysis
Actively leads BeOne safety in face-to-face regulatory meetings
Actively 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 and leads medical review of SAEs and provides immediate input to escalated reports, determines, and executes further escalation within BeOne as needed
Leads and develops strategic plans for safety differentiation of BeOne products, provides training BeOne 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 BeOne functions (Legal, Bus Dev, Operations, Marketing, etc.), executes appropriate communication of safety data and interpretation to BeOne and external parties, globally, facilitates communication with country office medical directors as required.
Leads EU/International Safety Communication & Co-ordination training to BeOne employees on product safety issues and profiles
Accountable for the collaborative authoring of safety content in clinical trial documentation, including but not limited to protocols, IBs, and ICFs. Able to collaborate and advise on technical aspects of trial design including escalation and expansion design, DLT criteria, inclusion and exclusion criteria, and risk monitoring and management aspects.
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. Expected to demonstrate and model responsive and collaborative medical review of ICSRs and aggregate safety reviews with cross functional colleagues.
Accountable for the content of safety sections of the Development Safety Update Report (DSUR), reviews and approves
Accountable 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 assessment
Actively 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 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 output/summary report for inclusion into clinical, filing
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)
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
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
Actively leads contribution to development of differentiation of BeOne products, provides training guidance to marketing training materials, reviews, and contributes to marketing materials
Leads GPS product co-ordination, chairs product group meetings across GPS
Leads and manages safety PV processes for BeOne and competitor products
Accountable for the development of Product Safety Strategy and the writing and maintenance of the Safety Surveillance Plans
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 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
Actively leads the scope, strategy, and content of responses to HA assessment reports, contribute to authoring of relevant sections
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 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 papers
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
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