Senior Director, Head of Safety Epidemiology
Remote (US)
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.
General Description:
Provide leadership in observational research and influence BeiGene’s global strategy to integrate epidemiology into the new drug development process and post marketing safety; Evaluate the overall R&D therapeutic area strategy globally to assist company in evaluation of the research portfolio; Improve design of clinical research programs, anticipate pre- and post-approval clinical safety issues, and contribute to their successful management; Serve as BeiGene’s epidemiological expert in meetings with Senior Management, Regulators, KOLs, etc.; Expand market awareness to improve the commercialization of BeiGene products.
Essential Functions of the Job:
Responsible for:
Defining and advising on Global Epidemiology strategy and methodology across functions within BeiGene
Owning and executing pharmaco-epidemiological programs for BeiGene and competitor products
Leading or conducting all aspects of study analyses from secondary sources such as administrative claims or electronic health record data
Assisting Lead Product Safety Physicians and BeiGene staff in managing safety concerns
Managing supporting epidemiology staff
Safety Pharmacoepidemiology (PE) Elements of the Following Activities:
Global PE Strategy
Develop and implement a Global PE strategy
Develop and Implement PV-Epi Research Program for Safety Issues
Develop product specific safety elements into a single PV-Epi strategy
Contribute to the design of registries and other primary data collection studies
Create definition of publication needs; Identify vendors to support PV-Epi strategy; Execute Epi studies
Epidemiologic and Statistical Methods
Develop appropriate methods to support PV-Epi strategy
Background Rate of Safety Issues
Design and conduct studies, provide results to support PV activities and Safety Topic Review background
Epidemiologic Studies
Design protocols and conduct/contract study execution
Safety PV Processes
Create and manage safety PV processes for BeiGene and competitor products
Product Safety Surveillance Plan
Contribute to surveillance plan preparation for products in pre-market clinical trials for generation of hypotheses to investigate
Signal Detection and Analysis
Develop and maintain signal alert system and maintain signal detection methodology
Execute proactive, ongoing analysis of SAEs by system, compound, and TA to detect significant correlation/causation
Support trials safety analysis as required
Perform ongoing pharmacovigilance to determine and review for quality-related signals across SAEs
Maintain Product Safety Profile
Contribute to development and maintenance of product safety profile
Develop content for epidemiologic sections of risk management plans, benefit risk assessments and regulatory deliverables
Aggregate Safety Reports
Provide epidemiologic input to PSRs/PSURs/PBRERs as required
Contribute to the development of the DSUR
Company Safety Committee (CSC)
Contribute to the generation of materials for CSC review and support Safety Management Teams (SMTs)
Contribute to package insert/ labeling update impact summaries for use by CSC
Presentations and attendance as appropriate to the CSC
Product Labeling Core Data Sheet Creation
Support safety input to core data sheet development
Issues management
Contribute to crisis management through developing context, strategies, and generation of epidemiologic analyses for interpretation of context.
Regulatory and Safety Enquiries (Internal, External HCP and consumer)
Review strategy and relevant data required for response
Provide latest updates and findings from ongoing epidemiological analysis
Response drafting (for relevant areas) and review data and draft response
Risk Management Plan development
Contribute to RMP content determination and plan drafting
Contribute to the review of emerging data against RMP content
Post Approval Commitments
Contribute to the design and implementation of PAC safety studies
Global Product Teams and Development Committees
Participate in meetings as appropriate and review of GPT materials
Assist Lead Product Safety Physicians in development of safety data presentation
Develop context, background data relevant to GPT topics
Trial Safety Support
Provide Epi strategy for defining context around emerging trial safety issues
Investigator Brochure
Provide supporting safety data for context to other sections as needed
IRB Updates / Responses
Support responses to specific inquiries; Formulate and communicate Institution or Centralized IRB requests
Support provision of ongoing updates of data and findings for IRB’s
Individual Study Planning
Clinical Protocol and Safety Endpoints Definition
Contribute to the provision of safety data on the compound of interest
Support review and provide advice on Safety Endpoints, data to capture during trial, process, key review activities and timing
Support protocol updates during study conduct as required
Statistical Analysis Plan
Support recommended data requirements into data management plan
Clinical Data Management Plan
Support data determinations for capture during clinical trials
Developmental Product Safety Monitoring and Surveillance (protocol & product specific)
Develop aggregated Safety/Clinical database analysis for AEs and SAEs matching hypothesis
Study Safety Data Review and Interpretation
External DMCs/ Internal SMCs
Provide input to DMC Charter
Support meetings through safety data interpretation
Review of DMC/SMC materials
Clinical Study Reports
Provide additional summary Epi analysis to support study results
Contribute to the request and receipt of Integrated Summary of Safety tables from biostatistics
Contribute to the review and prose generation for Safety sections of each trial’s outputs, as well as synthesized summary across all trials
120 Day Update
Provide latest updates and findings from ongoing pharmacovigilance and epidemiological analysis for incorporation into the 120-day update
Compliance, Standards, Training & Project Management
Preparation for Regulatory Inspection
Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates
Extra-Departmental Liaison and Co-ordination
Commercial / Marketing Support
Contribution to development of differentiation of BeiGene products
Publications
Contribute to the determination of publication needs
Contribute to data assembly & analysis
Author Epidemiological publications.
Review others’ draft publications, including abstracts, manuscripts, and speaker presentations
Supervisory Responsibilities
The position has two direct reports. The Senior Director, Lead Safety Epidemiologist is part of a team that performs high quality and timely scientific and operational safety analysis. This position works closely with the Safety Sciences group as part of a matrix team to conduct safety assessment and safety risk management activities.
Requirements:
Ph.D. in epidemiology or MD/PhD combination optional. 10 years relevant experience, including training. 6 years industry epidemiology experience. Pharmacovigilance experience required. Strong publication track record.
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 Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
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.
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Countries SkillsBiostatistics Clinical Clinical Research Clinical trials Compliance Data analysis Data Management Drug Development Epidemiology Leadership Observational Research Pharmacovigilance Project Management Regulatory Affairs Risk assessments Risk Management Safety Assessment Statistical analysis
Tasks- Conduct study analyses
- Contribute to regulatory deliverables
- Contribute to safety PV processes
- Develop Global PE strategy
- Develop product safety profile
- Lead pharmaco-epidemiological programs
- Manage safety concerns
- Training