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BeOne

Global oncology therapeutics discovery, development, manufacturing

Senior Medical Director – Product Safety Physician Lead

Biology & BiotechConfirmed live in the last 24 hours
Full-timeRemote in USA$298.2k - $368.2k /yr

About the Job

Requirements

  • MD (or internationally recognized equivalent) plus accredited residency, with 6+ years of pharmaceutical/biotechnology industry experience in Clinical Research or Clinical Development and 4+ years of experience in safety in Phase 1 and Phase 2.
  • Prior matrix management team experience.
  • Prior experience as a product safety physician.
  • Pharmaceutical product development experience, including individual study design and filing plans.
  • Experience with global regulatory requirements for pharmacovigilance.
  • Appropriate experience interacting with Regulatory Agencies and key opinion leaders.
  • Intermediate knowledge of working with a safety database to retrieve safety information.
  • Advanced knowledge of MedDRA.
  • Advanced application capability with Excel, PowerPoint, and Word.
  • Familiarity with data mining and exploratory analysis tools such as Spotfire.

Responsibilities

  • Serve as Lead Product Safety Physician for multiple or large, complex, strategically important developmental programs, often multi-indication, and create and maintain a unified interpretation of global developmental safety data.
  • With support from Safety Physicians and Safety Scientists, identify and manage documentation and communication of safety concerns, ensuring patient safety in BeOne-sponsored studies.
  • Oversee the benefit-risk safety profile of allocated products throughout the product life cycle, with a primary focus on early development.
  • Lead and enhance knowledge of safety profiles for allocated products, including BeOne and competitor products.
  • Identify and lead management of safety concerns for developmental and approved BeOne products.
  • Lead Development and, as required, Medical Affairs product teams in identifying and handling product safety concerns.
  • Chair Safety Management Team meetings for assigned products, review meeting materials, and develop and represent the safety perspective.
  • Represent the Safety Management Team and participate in Company Safety Committee meetings; support preparations and propose review topics and agenda items.
  • Lead communication of recommendations to labeling groups and other stakeholders.
  • Participate in External Safety Monitoring Committee meetings by providing and reviewing safety data and insights, providing leadership, and contributing to committee charters.
  • Lead Internal Safety Monitoring Committee meetings, such as dose-escalation safety meetings, and contribute to safety charters.
  • For later development programs, lead communication of Company Safety Committee recommendations for labeling amendments, participate in Labeling Working Group meetings, and communicate safety outcomes to stakeholders.
  • Lead development and maintenance of Company Core Safety Information, propose edits, and manage approval of amendments.
  • Present Company Core Safety Information to the labeling committee, contribute to Company Core Data Sheet development, and review the company core data sheet.
  • Provide safety insights for Package Insert and labeling updates; develop labeling update impact summaries for Regulatory Affairs and draft labeling text updates based on internal aggregated reports.
  • Lead escalation of potential issues to the Safety Management Team, ensure internal notification, and provide updates.
  • Develop issue-management strategies and facilitate internal approval of plans.
  • Lead review of issue data and closure on recommendations; draft issue response documents and review and manage approval of issue-response documentation and responses.
  • Formulate rapid-response procedures, triage potential issues to the safety committee, execute Crisis Management response plans, and review ongoing issues and plans.
  • Review regulatory inquiries to determine response strategy and data specifications, and review relevant response data.
  • Lead and contribute to formal responses to regulatory agencies, review drafts, and manage response approval.
  • Lead incorporation of current findings from pharmacovigilance and epidemiological analyses.
  • Represent BeOne Safety in in-person regulatory meetings.
  • Lead evaluation of internal, external, healthcare professional, and consumer safety enquiries; assign response drafting, determine required data, review data and drafts, and manage approval.
  • Guide and lead medical review of serious adverse events and provide immediate input to escalated reports; determine and execute further escalation within BeOne as needed.
  • Develop strategic plans for safety differentiation of BeOne products, train employees on product safety profiles and issues, contribute to commercial publication strategy, review publications and speaker presentations, and provide input on potential in-licensing opportunities as requested.
  • Lead product liaison for BeOne functions including Legal, Business Development, Operations, and Marketing; communicate safety data and interpretation to internal and external parties globally and facilitate communication with country-office medical directors as required.
  • Lead EU and international safety communication and coordination training for BeOne employees.
  • Collaboratively author safety content in clinical trial documents, including protocols, Investigator’s Brochures, and informed consent forms; advise on technical trial design, including escalation and expansion design, dose-limiting toxicity criteria, eligibility criteria, and risk monitoring and management.
  • Review safety data and advise on safety endpoints, safety-related eligibility criteria, trial data capture, review activities and timing, program-wide safety issues, protocols, and protocol updates; conduct responsive collaborative medical review of individual case safety reports and aggregate safety reviews.
  • Own safety content in Development Safety Update Reports and review and approve those reports.
  • Develop and maintain reference safety information, contribute to safety sections of Investigator’s Brochures and informed consent forms, and manage any need to re-consent participants in ongoing trials based on emergent safety assessments.
  • Lead development of expected statistical analyses for trial analysis plans and provide program-wide input on safety statistical elements.
  • Recommend safety data requirements and author safety sections of clinical data management plans; support plan review and updates based on changes to the integrated safety viewpoint.
  • Determine safety data to capture in clinical trial case report forms and provide program-wide input to case report forms.
  • Develop safety criteria and review study-specific medical monitoring plans.
  • Participate in investigator meetings as needed and own the product safety profile; review, approve, and update safety presentation content.
  • Prepare output and summary reports for inclusion in clinical and filing documents.
  • Review serious adverse events and abnormal laboratory results daily, weekly, and monthly; conduct protocol-specific aggregate serious adverse event reviews and analyses of aggregate clinical trial database outputs, including adverse event tables, shift tables, and listings.
  • For later development programs, review and interpret study safety data, support clinical study report narrative generation, lead interpretation-based safety report sections, and review draft reports.
  • Draft safety sections of the Summary of Clinical Safety and Integrated Summary of Safety.
  • Lead 120-day update plans and activities.
  • Represent and promote Safety on product development teams as a core team member and contribute to development strategy for allocated compounds.
  • Lead preparation for and attend clinical team meetings.
  • Lead contributions to product differentiation, provide training guidance for marketing materials, and review and contribute to marketing materials.
  • Lead Global Patient Safety product coordination and chair product-group meetings across Global Patient Safety.
  • Lead and manage safety pharmacovigilance processes for BeOne and competitor products.
  • Develop Product Safety Strategy and write and maintain Safety Surveillance Plans.
  • Lead safety issue assessment and documentation, determine issue scope, and execute risk assessment.
  • Develop and update summaries of competitor safety profiles, labeling, freedom-of-information information, and issues.
  • Develop and maintain product safety profiles and Events of Interest.
  • Present data at scheduled and ad hoc product safety reviews, chair review meetings, identify issues for escalation, determine whether safety concerns require management escalation, and facilitate closure on recommendations.
  • Develop and maintain updates to Product Surveillance Plans.
  • Lead the scope, strategy, and content of responses to health authority assessment reports and contribute to relevant sections.
  • For later development programs, define Risk Management Plan drivers and content, review core and local Risk Management Plans or Risk Evaluation and Mitigation Strategies, lead execution and documentation of plan elements, evaluate potential risks, and recommend plan updates.
  • For later development programs, develop safety post-approval commitment proposals, facilitate design of proposed safety studies, and execute post-approval commitment studies.
  • For later development programs, define events of interest and case follow-up needs.
  • For later development programs, develop and implement product launch plans.
  • Develop a publication plan and contribute to draft papers.
  • Contribute to and promote development of a global pharmacoepidemiology strategy.
  • Evaluate current processes and assess alignment with regulatory expectations, guidelines, and mandates for regulatory inspections.
  • Train and mentor Safety Physicians and Safety Scientists.
  • Lead and maintain continuous improvement within the team and contribute to continuous-improvement initiatives across Global Patient Safety.

Desired Qualifications

  • An accredited fellowship with one year of clinical patient experience in a relevant therapeutic specialty and significant knowledge of general medicine.
  • Experience in oncology in the preapproval space.

About the Company

BeOne

Global oncology therapeutics discovery, development, manufacturing

BeOne Medicines discovers, develops, and commercializes oncology therapies worldwide, focusing on hematologic cancers and solid tumors. Its products work by leveraging internal R&D and clinical development to bring therapies to market quickly, with Brukinsa serving as a leading backbone in the US and European markets. It differentiates itself through a large-scale global clinical network and cost-efficient development and manufacturing that support high margins and a focus on large-market cancer indications. Its goal is to expand access to high-impact, affordable cancer treatments across more than 45 countries while growing its pipeline into immunology and solid tumors.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Dongcheng District, China
Founded
2010

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