Jobs at Formation Bio

Build and operate production software for active clinical trials, including clinical-system integrations, trial data flows, site activation, monitoring, and signal detection. Design AI-native agents and pipelines with auditability, provenance tracking, and human review in regulated GxP environments. Own multi-quarter technical initiatives, collaborate with clinical, regulatory, QA, data, and infrastructure teams, mentor engineers, and improve validated software delivery workflows.

Leads the data engineering team, including hiring, coaching, technical direction, platform architecture, data pipelines, Snowflake warehousing, governance, quality, observability, and incident support. Partners with Data Science, Analytics, Clinical Operations, Biostatistics, and Business Development to deliver trusted data products for clinical operations, asset evaluation, reporting, and machine learning. Oversees budgeting, resourcing, documentation, technical programs, and responsible use of AI engineering tools.

Lead the infrastructure and SRE team, setting technical direction for reliable, secure, and scalable engineering systems. Hire, coach, and develop engineers; oversee multi-cloud infrastructure, Kubernetes, IaC, CI/CD, observability, incident response, support rotations, and regulated workloads. Partner across engineering, data science, security, and operations to improve developer experience and enable safe AI-assisted software delivery. Manage infrastructure roadmaps, budgets, resourcing, documentation, and organizational reliability practices.

Owns R&D data governance, records integrity, AI oversight, and quality technology systems including Veeva Quality Docs and DocuSign Part 11. Leads risk assessments, data migration, digitization, computerized system compliance, vendor qualification, CAPAs, audits, and inspection readiness. Advises R&D on data stewardship and responsible AI use while establishing governance frameworks, controls, and Quality by Design practices. Director-level responsibilities include setting strategy and representing Quality Governance during regulatory inspections.

Lead GMP quality assurance for biologics programs, ensuring regulatory compliance, batch review and release, supplier/CDMO oversight, investigations, audits, quality agreements, and risk-based continuous improvement while exploring AI to enhance QA efficiency.

Lead the strategy and execution of real-world data capabilities, focusing on data lifecycle management, vendor relationships, and collaboration with various teams to deliver analysis-ready datasets.

Lead bioanalytical strategy and execution for drug development programs, manage CROs, oversee assay validation and data review for clinical trials.

The Senior Data Engineer will transform real-world data into analytics-ready datasets, build scalable pipelines, and conduct analyses to support scientific and business decisions, collaborating closely with data science teams.

Leads the strategy for scaling data science analyses used in pharmaceutical asset acquisition and diligence. Directs cross-functional Data Science and Engineering teams, determines which one-off analyses should become landscape analyses or durable tools, sets roadmaps, evaluates statistical and technical validity, identifies AI opportunities, and connects scientific findings to business impact, asset valuation, and sourcing decisions.

Lead financial reporting, US GAAP financial statement preparation, complex consolidations, technical accounting, financial close, controls, and external audits. Prepare technical accounting memos, journal entries, disclosures, workpapers, and accounting policies. Support separately audited venture fund reporting, coordinate with auditors and third-party administrators, and partner with Legal, Business Development, R&D, and Clinical Operations. The role begins as a senior individual contributor with potential to build a reporting team.

Lead technical recruiting for data science, engineering, and product teams: own full-cycle hiring, partner with senior leadership on hiring strategy, use AI tools to source and evaluate candidates, drive process improvements and employer branding, and build pipelines through creative sourcing and events.

The Senior Manager, Brand & Communications will oversee internal communications, brand initiatives, and operational excellence to enhance employee connectivity and brand presence in the pharma and AI landscape.

Lead product strategy and execution across drug development platforms, leveraging AI and cross-functional teams to improve outcomes in clinical trials and regulatory processes.

Lead data science projects to advance drug development, implementing models for patient selection and clinical trial optimization, and collaborating with cross-functional teams.

Lead the integration of advanced imaging analytics and AI in drug development, focusing on medical image analysis and clinical trials.

Lead data science projects to optimize drug development, develop AI models for clinical trials, and collaborate with teams on biomedical workflows.

Lead the integration of advanced imaging analytics and AI into drug development, focusing on medical image analysis using deep learning. Collaborate with clinical teams and develop models for disease detection and treatment response assessment.

Lead preclinical pharmacology strategy across programs: design, oversee, and interpret CRO-executed animal and pharmacology studies, integrate PK/PD and biomarker plans, partner cross-functionally (DMPK, toxicology, clinical, regulatory), manage vendors and data quality, and apply modeling, analytics, and AI-enabled tools to support candidate selection and regulatory decision-making.

Lead data science projects to optimize drug development using AI. Develop models for patient selection and clinical trial evaluations while collaborating with cross-functional teams to drive insights.

Lead asset-level quality strategy by embedding Quality by Design, mapping risks/opportunities, conducting due diligence for in-licensed assets, driving audit-readiness for acquisition/commercial transitions, and applying global regulatory expectations (FDA/EMA/ICH) in AI-accelerated and digital environments.