Senior Director, Head of Safety Epidemiology

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.