Jobs at Formation Bio

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 People operations, design and scale performance, promotion, compensation, and benefits programs, drive AI-native people systems and processes, partner with leaders on organizational strategy, manage vendors, and coach managers through complex people matters.

The role involves managing analytical development and quality control for small molecules and biologics, overseeing method validation, vendor management, and stability programs, while collaborating with CMC, QA, and Regulatory teams.

Lead a drug asset as the accountable GM, owning strategy, P&L, budgets, and execution. Align cross-functional teams (clinical, tech, CMC, regulatory, data science), run governance and roadmaps, track milestones and ROI, make high-stakes decisions, and drive value inflection using AI-enabled leverage and disciplined operational rhythms.

Lead and build an AI-native Medical Affairs function for Sprifermin and assigned programs. Set medical strategy from late development through pre-launch, drive KOL engagement, publication and RWE plans, embed medical input into cross-functional planning, and implement scalable, technology-forward MA infrastructure and teams.

Lead end-to-end clinical operations including site start-up, patient recruitment, trial execution, and clinical data management. Build AI-native operations, integrate eClinical technology stack (ARK/EDC/CTMS/ePRO), implement RBM and adaptive methods, manage CRO/vendor governance, and scale a high-performance team to accelerate Phase 2/3 trials with data-driven oversight.

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.

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.

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

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 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.

As a Data Scientist, you'll build and maintain portfolio systems, design risk frameworks, run backtesting experiments, and collaborate across teams to enhance portfolio analytics using AI-driven predictions.

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 clinical pharmacology efforts for late-stage drug development, oversee clinical studies, mentor teams, and ensure regulatory compliance.

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.