Senior Director of Real World Data (RWD)

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.