Associate Director, Real-World Evidence, China

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OBJECTIVES/PURPOSE

• Leads the development and execution of integrated evidence generation plans (IEPs) for China particularly real-world evidence (RWE) strategies translating local medical patient payer health-system and business questions into scientifically robust feasible and compliant evidence plans.
• Serves as the strategic China RWE lead and trusted advisor for assigned pipeline and in-line assets current focus: Oncology Gastroenterology (GI) Rare Disease (RD) and Plasma-Derived Therapy (PDT) with scope determined by portfolio priorities ensuring prioritized China needs are incorporated into local and global IEPs.
• Provides scientific leadership for RWE that demonstrates treatment impact and value in routine practice including treatment patterns real-world effectiveness and outcomes comparative effectiveness healthcare resource utilization patient-centered research and market access evidence.
• Provides authoritative oversight of the China RWE portfolio including prioritization study strategy budgets external partnerships resources timelines risk management scientific quality communication and compliant delivery.
• Drives responsible innovation by leveraging fit-for-purpose real-world data (RWD) advanced analytics visualization automation and AI-enabled tools to strengthen evidence planning study delivery and decision-making with appropriate human oversight validation verification transparency confidentiality and accountability.

ACCOUNTABILITIES

• Develops and communicates integrated China RWE strategies and evidence plans for assigned assets aligned with product development stage China medical and access priorities brand and launch plans and global IEPs.
• Leads cross-functional identification prioritization and communication of China evidence needs partnering with TA Evidence Heads Medical Affairs HE/HTA Market Access Commercial Clinical Development Safety other regional and global evidence generation teams and other relevant functions.
• Generates evidence on treatment impact and value in routine practice including treatment patterns real-world effectiveness and outcomes comparative effectiveness healthcare resource utilization costs patient-reported outcomes patient-preference evidence and unmet needs.
• Provides strategic recommendations on evidence investment study sequencing data and partnership strategy resource allocation and portfolio prioritization based on patient impact decision value feasibility timing quality risk scalability and potential for reuse.
• Leads the scientific design and delivery of fit-for-purpose observational database pragmatic and patient-centered research including retrospective database studies chart reviews prospective cohorts registries natural-history studies drug-utilization studies external or historical controls pragmatic trials Delphi studies and post hoc or post-trial analyses.
• Provides scientific leadership across the study lifecycle including concept development governance review protocol and analysis plan development feasibility data-source assessment interpretation reporting publication and evidence application.
• Partners with China Study Operations on the operational execution of interventional and site-based non-interventional studies.
• Evaluates whether real-world data are fit for the intended research question by assessing data provenance relevance completeness accuracy representativeness timeliness coding quality outcome validity linkage feasibility regulatory compliance and long-term sustainability.
• Applies and critically evaluates epidemiologic biostatistical comparative-effectiveness and causal-inference methods ensuring that assumptions bias uncertainty limitations and generalizability are transparently assessed and communicated.
• Prepares and critically reviews study concepts protocols analysis plans data and output specifications reports abstracts posters manuscripts and other scientific deliverables ensuring analyses are robust transparent reproducible and fit for purpose.
• Leads China-specific data landscaping and data-vendor evaluation and provides strategic and scientific input into data feasibility common data models analytics visualization digital solutions and responsible AI-enabled innovation.
• Contributes RWE and health-outcomes inputs to economic models value narratives HTA or payer evidence packages payer and health-system partnerships and market access decisions in collaboration with HE/HTA and Market Access colleagues.
• Leverages digital platforms advanced analytics visualization automation and AI-enabled tools for evidence planning targeted literature review feasibility analytics quality checks portfolio oversight and communication; critically evaluates AI-assisted outputs and ensures human accountability verification transparency data confidentiality and compliant use.
• Represents China in relevant global product evidence development and launch workshops; contributes China healthcare-system RWD payer policy method and feasibility insights; and supports local adaptation of global evidence approaches and deliverables.
• Forms and leads agile cross-functional study teams without formal authority promotes streamlined governance and review and maintains clear strategic communication on priorities tradeoffs decisions progress and risks.
• Leads external research partnerships and provides scientific oversight of academic collaborators research organizations investigators data providers consultants medical writers and other vendors ensuring delivery of high-quality compliant and fit-for-purpose outputs within agreed scope budget and timelines.
• Builds trusted compliant scientific relationships with external experts academic institutions research networks data organizations payers health systems and professional societies; leads advisory boards expert consultations and scientific exchange where appropriate.
• Provides RWE expertise coaching and training to colleagues and contributes to standardization and continuous improvement of RWE methods governance templates vendor management quality controls innovation pilots and ways of working.
• Ensures all evidence generation data use external engagement publication and dissemination activities comply with applicable laws and regulations research ethics company policies and procedures pharmacovigilance requirements scientific good practice and data privacy and security requirements and supports local audit and inspection readiness.

EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS

Required:

• Masters degree in epidemiology health outcomes research public health data science biostatistics medicine pharmacy life sciences health economics or a related field; a doctoral degree is strongly preferred.
• At least 10 years of relevant experience in the pharmaceutical or biotechnology industry academia consultancy a contract research organization or a related environment including demonstrated leadership of evidence generation activities.
• Demonstrated experience shaping RWE strategy and leading or overseeing a portfolio of noninterventional observational database pragmatic or other medical evidence generation studies across multiple product lifecycle stages.
• Demonstrated application of RWE to meaningful medical payer health-system market access development or lifecycle decisions in China.
• Strong knowledge of observational research epidemiology pharmacoepidemiology biostatistics causal inference comparative effectiveness research patient-centered and patient-preference methods good research practices and applicable ethical and regulatory requirements.
• Strong understanding of Chinas healthcare and reimbursement system and evolving evidence expectations together with in-depth knowledge of RWD sources and the respective strengths and limitations of electronic medical or health records claims registries medical charts patient-generated data and linked datasets.
• Ability to translate medical patient payer health-system and business questions into clear research questions evidence needs fit-for-purpose study designs data strategies analytical plans and executable research plans.
• Strong scientific judgment with the ability to assess RWD are fit for purpose and critically evaluate study designs protocols analysis plans programming and output specifications data quality analytical methods potential bias uncertainty generalizability and scientific conclusions. Ability to provide effective scientific oversight of programming and analytics.
• Strong understanding of applicable requirements in China related to research ethics data privacy and security human genetic resources pharmacovigilance scientific publication study governance and audit or inspection readiness.
• Demonstrated project portfolio vendor and budget leadership with the ability to manage multiple complex studies external partners priorities timelines risks and tradeoffs.
• Experience collaborating with regional or global teams HE/HTA Study Operations or Data Digital & Technology functions in a large matrixed organization.
• Proven ability to influence senior local regional and global stakeholders and lead agile cross-functional and matrix teams without direct authority.
• Strong strategic communication facilitation negotiation and presentation skills including the ability to translate complex methods and findings into clear balanced and decision-relevant recommendations.
• Ability to work independently manage ambiguity adapt to evolving methods and technologies and deliver high-quality outcomes in a changing environment.
• Experience engaging external scientific experts academic institutions research networks data partners payers health systems professional societies or relevant authorities.
• A record of scientific publication congress presentation and evidence dissemination; experience mentoring colleagues or providing functional leadership is an advantage.
• Professional fluency in written and spoken Chinese and English.

Desired:

• Working proficiency in at least one programming language such as R SAS Python or SQL; familiarity with relevant data standards and advanced RWE methods including common data models and target trial emulation.
• Demonstrated experience using digital tools RWD platforms analytics visualization automation or AI-enabled tools to support evidence strategy and delivery with sound judgment regarding validation confidentiality transparency human oversight verification and compliant use.
• Experience using advanced analytics automation machine learning or generative AI in RWE including responsible evaluation and implementation of AI-enabled processes.