Executive Medical Director, Product Safety Physician Lead

4 weeks ago

San Mateo, California, United States BeiGene Full time
Job Title: Executive Medical Director, Product Safety Physician Lead

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.

Key Responsibilities:

  • Accountable for oversight of benefit/risk safety profile of allocated products through the product lifecycle
  • Actively leads and enhances knowledge of safety profiles for allocated products, including both BeiGene and competitor products
  • Identifies and actively leads management of safety concerns for developmental and approved BeiGene products
  • Actively 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 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

Product Labeling:

  • 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
  • Present the CCSI to the labeling committee, contributes viewpoint to CCDS development, and reviews company core data sheet

Issues Management:

  • 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

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.

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

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

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

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

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 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 SAEs by system, compound, and TA to detect significant correlation/causation, develops monthly signal detection reports using internal and external data

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

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

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

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