Department: Medical Affairs
Reports To: Sr. Director, HEOR
A Ph.D. in Epidemiology, Health Economics, Outcomes Research or related discipline is preferred with 5+ years of related experience in Hematology/Oncology, or candidates with a master’s degree with 7 years of relevant experience will be considered.
Hours: 40 hours/week
Over-time may be required on occasion
This position will lead and manage epidemiology / health economics and outcomes research programs to ensure quality, time and budget deliverables to support Beigene’ products. Work closely with other functional groups by providing epidemiology and outcomes research leadership for observational research on the natural history of disease and comparative safety, effectiveness and cost of medical treatment. Design methodologically sound studies to meet project objectives and regulatory and payer requirements. Conduct and supervise analyses, evaluation and reporting of studies.
- Develop the evidence generation plan and provide Epi/HEOR inputs to the brand planning and budgeting processes and formulate recommended strategies in support of asset value proposition in collaboration with the internal teams.
- Provide input on clinical trial design from an Epi/HEOR perspective and ensure inclusion of appropriate PRO and health economic endpoints into clinical trials to maximize asset value proposition in collaboration with the clinical development team.
- Ensure incorporation of epidemiology / HEOR, starting early in development, for enhanced informed decision-making (e.g., go/no-go, clinical trial design).
- Ability to work in a cross-functional matrix team environment and effectively communicate relevant Epi/HEOR strategies and evidence studies outputs
- Represent Beigene before appropriate scientific, medical, regulatory, payer, patient and other meetings, when appropriate with some/minimal oversight by TA Director/Lead.
- Keep abreast of the trends of therapeutic area, Epidemiology, and HEOR across key regions (US, EU, and China, and other markets), and proactively address epi/HEOR strategy changes in collaboration with global and regional teams in anticipation of these trends.
- Collaborate with scientific communications to provide HEOR input on scientific platform and develop HEOR-related scientific publications.
- Design and conduct real-world evidence studies to ensure timely quantitative understanding of economic, humanistic and clinical burden of disease, disease sequelae and patient journey to enhance clinical trial design, to provide input to go/no-go decisions at each development milestone, as well as to maximize market uptake in all relevant markets.
- Translate (early) trial efficacy to real-world comparative effectiveness for study planning, identification of subpopulations, and potential risk-sharing purposes.
- Explores, requests approval and implements new concepts that are complex. Takes appropriate risks to advance innovative processes and methodologies based on comprehensive business knowledge, e.g. new methods for analyzing PRO data or claims data.
- Serves as project lead on research projects.
- Work with internal partners and interact with external consulting forms/KOLs to deliver study results/publications.
- Authors protocols, reports and other study documents with independent, critical thinking to ensure quality and completeness of output, oversees timeline for deliverables associated with analysis and reporting.
- Reviews and provides relevant epidemiological and outcomes research input to statistical analysis plans and analysis output.
- Reviews and provides epidemiology and outcomes research input for tasks including CRF/eCRF development, form previews and other ad hoc project tasks (e.g., regulatory responses, slide deck development).
- Independently generates content and direction for business development proposals.
- Helps to define and provide appropriate levels of professional development and training for staff.
- Uses best efforts to complete work with available budget.
- Represents Beigene externally through conference presentations/communications.
- May oversee or conduct statistical analysis as needed.
- Represent BeiGene on Epidemiology/HEOR issues at national and global forums, conferences and professional associations; including monitoring and communicating activities
- Experience with post-marketing “real world evidence” studies and registries
- Ensure function maintains full compliance with internal and external guidance and regulations, including applicable policies and codes
- Proven ability to drive results at a high level of quality as a strategic and creative thinker/leader.
- Demonstrates ability to deal with ambiguity and thrive in an ever-changing environment.
- Ability to design, plan and conduct observational studies of comparative effectiveness, safety and cost.
- Excellent oral and written communication skills and presentation skills.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients in a global and matrixed environment.
- Ability to effectively prioritize and manage multiple tasks and projects.
- Must be proficient in Word, Excel, PowerPoint and Internet Explorer.
- Must be highly organized and self-motivated with ability to determine and meet objectives.
- Ability and interest in managing and supporting the development of one or more junior team members.
Travel: Work related travel approximately 20-30%
Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management – Communicates changes and progress; Completes projects on time and budget