高级总监,真实世界数据(RWD)
Senior Director, Real World Data (RWD)
关于该职位:
作为真实世界数据(RWD)高级总监,您将负责定义、开发和实施我们的RWD策略、平台和数据流程,将多样化的真实世界数据转化为符合监管标准、可供研究的资产,以推动我们的临床开发、证据生成、数字健康产品和产品组合。您将在影响监管决策方面发挥关键作用,提高临床试验效率,评估和实施AI/代理工作流程,以增强我们的RWD平台,并弥合临床研究与医疗实践之间的差距,从而改善患者结果并推进我们“无疾病世界”的愿景。
高级总监将领导所有信息学方面的开发和维护“符合监管标准”的RWD流程。具体来说,高级总监将领导RWD信息学团队,将电子健康记录(EHR)、索赔、影像和其他RWD来源转化为可被我们的生物统计学家、计算科学家和其他终端用户访问的研究就绪数据集,同时确保数据质量、操作效率和可扩展性。
这些努力将有助于开发和商业化基于临床和多组学数据的早期癌症检测产品组合以及数字健康解决方案,使支付方、提供方和患者能够在治愈性干预最可行时及早发现癌症。
该职位向首席产品官汇报。该职位为远程办公。
您将负责:
- 领导我们的RWD整理流程的运营和持续改进,根据需要管理内部和外部资源。评估并整合代理工作流程和AI,以确保准确性,增强可解释性和质量,并提高我们RWD工作的效率。这包括:
- 设计和实施流程、分析方法和AI工具,以整合多种RWD来源。
- 准备用于分析的数据,包括数据清洗和映射。
- 在需要时确保“符合监管标准”的数据质量。
- 开发可扩展的非结构化数据整理操作,尽可能利用自动化,并仅在必要时临时使用手动技术,同时制定路线图以适当消除这些步骤。
- 制定全面的、多年期战略,用于RWD的获取、管理、整理和使用,以支持监管提交、临床证据生成、健康经济学
查看英文原文
About this opportunity:
As the Senior Director of Real World Data (RWD), you will be accountable for defining, developing, and implementing our RWD strategy, platform, and data pipeline to transform diverse real-world datasets into regulatory-grade, research-ready assets that drive our clinical development, evidence generation, digital health products and product offerings. You will play a key role informing regulatory decisions, improving clinical trial efficiency, evaluating and implementing AI/agentic workflows to strengthen our RWD platform and help bridge the gap between clinical research and medical practice to improve patient outcomes and advance our vision of a world without disease.
The Senior Director will lead all informatics aspects of developing and maintaining a “regulatory-grade” RWD pipeline. Specifically, the Senior Director will lead the RWD Informatics team in turning electronic health records (EHR), claims, imaging, and other RWD sources into research-ready datasets accessible by our biostatisticians,computational scientists and other end users while ensuring data quality, operational efficiency, and scalability.
These efforts will contribute to developing and commercializing a portfolio of early cancer detection products — based on both clinical and multiomics data — and digital health solutions that will enable payers, providers, and patients to catch cancers early when curative intervention is most achievable.
The role reports to the Chief Product Officer. This role will be a Remote role.
What you’ll do:
- Lead the operations and continuous improvement of our RWD curation pipeline, managing internal and external resources as needed. Evaluate and integrate agentic workflows and AI to ensure accuracy, augment the interpretability and quality, and drive efficiencies across our RWD efforts. This includes:
- Designing and implementing processes, analytical methods, and AI tools to integrate a variety of RWD sources.
- Preparing data for analysis, including data cleaning and mapping.
- Ensuring “regulatory-grade” data quality where required.
- Developing a scalable unstructured data curation operation, leveraging automation as much as possible and only transiently leveraging manual techniques with a roadmap towards eliminating these steps as appropriate.
- Create a comprehensive, multi-year strategy for the acquisition, management, curation, and use of RWD to support regulatory submissions, clinical evidence generation, health economics and outcomes research (HEOR), and commercial efforts such as patient identification and care navigation.
- Architect, build, and maintain a robust, efficient, and scalable RWD platform and pipeline capable of ingesting, linking, harmonizing, and curating large, complex, and disparate real-world datasets such as Electronic Health Records (EHRs), claims data, imaging, and registries of structured and unstructured data.
- Lead clinical data analyses to support product strategy, development and commercialization to improve Freenome’s access to RWD and enhance future product offerings for HCOs.
- Serve as the RWD expert, proactively collaborating with Clinical Development, Biostatistics, Regulatory Affairs, Medical Affairs, Engineering, Science and Product and Commercial teams to ensure the RWD pipeline meets diverse end-user needs, clinical, scientific and commercial objectives.
- Contribute to defining the strategic direction of Freenome's data initiatives, in partnership with senior leadership and cross-functional teams.
- Support data acquisition by conducting technical due diligence, facilitating data acquisition agreements and defining data delivery specifications and lead data product implementation efforts into Freenome’s platforms with strategic partners and customers.
- Oversee the translation of raw RWD datasets into research-ready, regulatory-grade datasets, following OMOP or other industry-standard models, suitable for rigorous statistical analysis and real-world evidence (RWE) generation.
- Foster a quality mindset through data quality checks, governance policies, and standard operating procedures (SOPs) to ensure the integrity, privacy, security, and traceability of all RWD assets to meet regulatory requirements.
- Develop the team, building technical and leadership capabilities and coaching for high-performance proficiency.
- Directly lead a team of clinical informaticists and data analysts through clear direction and priorities and hands-on management to enable focused execution in alignment with company objectives.
- Manage the RWD department budget, ensuring efficient resource utilization and allocation of expenditures.
- Build and maintain a culture of collaboration and inclusivity both within RWD and cross-functionally across Freenome.
Must haves:
- Master’s or Ph.D. in Biostatistics, Epidemiology, Health Informatics, Computer Science, or a related quantitative field.
- At least 12 years of progressive experience in clinical informatics, including experience with:
- EHR, claims, other structured and unstructured RWD, and molecular data.
- Applying RWD to device, therapeutic and/or software product development.
- RWD across multiple disease areas, including oncology.
- At least 10 years of experience building and leading high-performing, multi-disciplinary teams.
- Demonstrated success operating within a matrixed organization and proactively collaborating with teams of internal and external partners to guide product delivery from concept to completion.
- Passion for getting in the trenches, leading by example, and scaling technical platforms and teams.
- Excellent written and verbal communicator with strong stakeholder management capabilities and problem-solving skills.
- Experience leading data modeling, terminology normalization, data curation and/or unstructured data abstraction via natural language processing (NLP).
- Deep knowledge of ontologies commonly used by health systems and payers (ICD-10, HCPCS, CPT, LOINC, RxNorm).
- Experience with Python, R, and/or SQL.
Nice to haves:
- Experience supporting real-world evidence FDA submissions or payer/guideline dossiers.
- Clinical background (MD, NP, RN, or similar) and/or degree in health informatics.
- Experience with cloud-based data storage and processing environments (e.g. AWS, Azure, GCP).
- Experience working directly with health systems or data vendors on data licensing and ingestion projects.
Benefits and additional information:
The US target range of our base salary rate for new hires is $236,300 - $335,475. You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ for additional company information.
Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Applicants have rights under Federal Employment Laws.
- Family & Medical Leave Act (FMLA)
- Equal Employment Opportunity (EEO)
- Employee Polygraph Protection Act (EPPA)
California applicants please review the CCPA Notice at Collection here:
· California Consumer Privacy Act (CCPA)
Originally posted on Himalayas