About the Position 

As Associate Director of RWD Intelligence at Formation Bio, you will lead the strategy and execution of our real-world data (RWD) capabilities, building the data foundations that power drug acquisition, clinical development, and portfolio decision-making. You will own the end-to-end lifecycle of RWD: sourcing, procurement, ingestion, harmonization, quality assurance, and delivery of analysis-ready datasets to downstream consumers across Product, Data Science, Clinical Development, and Business Development.

This role sits at the intersection of data engineering, data science, and drug development. You will build and maintain scalable data infrastructure (pipelines, data models, lakes/marts) while ensuring semantic interoperability across heterogeneous data sources through ontology-driven harmonization frameworks such as OMOP. You will also manage vendor relationships and data procurement, evaluating and integrating new data assets as the portfolio evolves. The ideal candidate combines deep RWD domain expertise with strong data fluency, enabling Formation Bio to treat real-world evidence as a first-class strategic asset.

Responsibilities

• Lead the RWD Intelligence function within Data Science, owning data strategy, sourcing, and delivery of analysis-ready datasets
• Architect and maintain the supporting infrastructure (pipelines, ingestion workflows, data models, lakes/marts) across EHR/EMR, claims, registries, and genomics-linked cohorts
• Drive adoption and extension of harmonization frameworks (e.g., OMOP CDM) across heterogeneous data sources, leveraging AI/ML tools for entity resolution, ontology mapping, data quality monitoring, and automated harmonization
• Manage RWD vendor relationships end-to-end: evaluate providers, negotiate data use agreements, broker new partnerships, and integrate acquired datasets into the platform
• Partner with Data Science, Clinical Development, Business Development, and Engineering teams to define RWD use cases (trial feasibility, synthetic control arms, epidemiology, label expansion) and productize ad hoc pipelines into scalable, production-grade systems
• Foster a culture of data quality rigor, documentation, and reproducibility across all RWD assets

About You 

Required Qualifications

• BSc or MSc in biomedical informatics, computational sciences, epidemiology, or a related quantitative field
• 5+ years of industry experience working directly with real-world data (EHR/EMR, claims, registries, linked biobank data) in pharma, biotech, health tech, or consulting, with at least 2+ years in people management
• Strong data engineering proficiency (pipelines, ingestion frameworks, data models, data lakes/marts) combined with deep working knowledge of biological and medical ontologies (ICD, SNOMED CT, MedDRA, RxNorm, ATC) and harmonization standards, particularly OMOP CDM
• Demonstrated experience with RWD procurement and vendor management: evaluating data providers, negotiating agreements, and integrating new data assets
• Proven ability to deliver RWD-derived insights across multiple drug development use cases (e.g., trial design, epidemiology, comparative effectiveness, label expansion), with familiarity across the development lifecycle from target selection through post-market
• Proficiency with modern AI/ML tools, including large language models, and their applications in data engineering and harmonization workflows
• Strong communication skills with the ability to translate complex data infrastructure concepts for clinical, scientific, and executive audiences

Preferred Qualifications

• PhD in biomedical informatics, epidemiology, computational biology, or a related field
• Experience with large-scale biobank and genomics-linked RWD platforms (UK Biobank, FinnGen, All of Us), with a track record of building RWD infrastructure that directly influenced drug acquisition, licensing, or portfolio decisions
• Familiarity with additional biomedical data modalities (scientific literature mining, -omics datasets, molecular data integration) and with data science/analytics methodologies applied to RWD (causal inference, trial simulation, propensity score methods)
• Background transitioning data infrastructure from research/ad hoc to production-grade systems in regulated environments
• Experience working at the intersection of data engineering, data science, and business strategy in pharma/biotech

Total Compensation Range: $204,500 - $267,000

About the Position

Formation Bio is looking for a talented Motion Designer to join our Brand team for the summer. This is a full-time, hands-on role for a creative who understands both storytelling and technology — someone who can translate complex product capabilities into compelling visual narratives for sophisticated audiences.

You'll work at the intersection of product and brand, producing animated explainers, product demos, and social-first content that brings Formation Bio's platform to life. You'll collaborate closely with our Head of Brand & Communications, Senior Manager of Content, and product teams to ensure every asset is accurate, polished, and resonant.

This role is a 3 month contract position, with full-time hours (or close to it) expected for the duration of the contract. Exact start and end dates are flexible

Responsibilities

• Ideate — Develop original concepts for animations, product demos, and brand content aligned with our voice and aesthetic
• Animate — Create motion graphics and animated explainers that make technical concepts clear and visually engaging
• Demo — Capture and edit high-quality product walkthroughs and screen recordings, with attention to pacing, narrative arc, and visual clarity
• Produce — Own pre-production end-to-end: storyboards, scripts, shot lists, screen capture workflows, and asset coordination
• Edit — Own post-production including cutting, color, sound design, voiceover integration, and motion graphics
• Deliver — Format and optimize content for LinkedIn, YouTube, Instagram, and other relevant platforms
• Collaborate — Work directly with Brand, Content, and Product teams to ensure accuracy, brand consistency, and audience fit

About You

• Strong portfolio showcasing motion graphics, animated explainers, or product demo work (portfolio required)
• Proficiency in After Effects; ability to animate from Figma design files a plus
• Experience with screen recording and demo capture workflows
• Comfortable with voiceover production and narrative scripting
• Proficient in Adobe Premiere Pro, Final Cut Pro, DaVinci Resolve, or equivalent
• Sharp eye for storytelling, composition, and visual style
• Familiarity with social-first formats and platform-specific best practices
• Experience creating content for tech, life sciences, finance, or other premium or technical brands preferred
• Comfortable in a fast-paced environment with tight turnarounds
• Based in New York City and available to work on-site

How to Apply

Please submit:

• Resume
• Portfolio (link preferred)
• A brief note on your creative approach and what excites you about this role

We review portfolios carefully — show us your best work.

Formation Bio is an equal opportunity employer. You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Compensation Range: $45.00 - $65.00/hour

About The Position

Formation Bio is looking for a talented Video Production Fellow to join our Brand team for the summer. This is a full-time, hands-on role for a creative who can own the entire video production process — from initial concept through final delivery — for a discerning, high-end audience. You will partner with cross functional team members across the business to develop and produce sophisticated video content for social media, bringing our brand to life through compelling visual storytelling.

This role is a 3 month contract position, with full-time hours (or close to it) expected for the duration of the contract. Exact start and end dates are flexible.

Responsibilities

• Ideate — Develop original video concepts aligned with our brand voice and aesthetic, tailored for social media audiences
• Produce — Manage all pre-production logistics including shot lists, schedules, talent coordination, and location scouting
• Film — Operate camera equipment and capture high-quality footage independently or with a lean crew
• Edit — Own the post-production process end-to-end, including cutting, color grading, sound design, and motion graphics as needed
• Deliver — Format and optimize content for relevant social platforms (Instagram, TikTok, LinkedIn, YouTube, etc.)
• Collaborate — Work directly with our Head of Brand & Communications and Senior Manager of Content to ensure all content meets brand standards and resonates with a sophisticated audience

About You

• Demonstrated ability to execute the full production cycle independently — ideation, production, filming, and editing
• Strong portfolio showcasing video work with a polished, high-quality aesthetic (portfolio submission required)
• Proficiency in industry-standard editing software (Adobe Premiere Pro, Final Cut Pro, DaVinci Resolve, or equivalent)
• Experience with motion graphics or animation (After Effects)
• Experience shooting with professional or prosumer camera equipment
• A sharp eye for storytelling, composition, and visual style
• Familiarity with social-first video formats and platform-specific best practices
• Photography skills
• Experience creating content for luxury, lifestyle, finance, or other premium brands
• Comfortable working in a fast-paced environment with tight turnarounds
• Based in New York City and available to work on-site

How to Apply

Please submit the following:

• Resume
• Portfolio (link preferred)
• Brief note on your creative approach and what excites you about this role

We review portfolios carefully — show us your best work.

Compensation Range: $45.00 - $65.00/hour

About the Position

Formation Bio is hiring Product Leads to own major problem domains across our drug development platform - for example, how we evaluate and acquire drug assets, how we design and run clinical trials, or how we build regulatory submissions. You will report to the CTO. 

This is a product leadership role, but not a traditional one. You won't be writing specs for engineers to build. You'll own a business domain: set the strategy, define what to build, lead a cross-functional team through delivery, and be measured on whether the work actually changes outcomes for the drug programs and business functions you serve. Your team will include engineers, data scientists, and product managers (ranging from senior ICs to managers).

You will be embedded with our clinical, translational, regulatory, and business development leaders - understanding their problems deeply enough to identify where technology can make a material difference. That means learning what makes a drug asset attractive, what drives a trial design decision, what the FDA cares about, and where the real time and cost sinks are. You should be able to drive value in a clinical review meeting in the same way you drive value in a sprint planning session.

We are not building consumer software. We are building tools, models, and systems that make specific drug development decisions faster and better - prediction models that assess drug candidate viability, AI-driven workflows that compress diligence timelines, and platforms that let non-engineers build their own analytical tools. You will own a slice of that work and be accountable for its impact.

Responsibilities

• Own the product strategy for a defined problem domain (e.g., drug candidate evaluation, clinical trial execution, regulatory intelligence). Define what to build, what to deprioritize, and how to measure success.
• Drive adoption of AI across your domain. We use LLMs, agentic workflows, and autonomous systems extensively. You should be pushing what's possible, not waiting for the technology teams to propose it.
• Design systems that domain experts across the company can build on directly. Non-engineers are already creating their own technology - your solutions should accelerate that, not bottleneck it.
• Lead a cross-functional team spanning engineering, data science, and product. Set the roadmap and make resourcing trade-offs based on business impact.
• Work directly with our core functional teams as a strategic tech partner. Translate their problems into technology solutions - not by taking feature requests, but by understanding the domain well enough to see opportunities they may not.
• Guide the data science and engineering approach within your domain, including real-world evidence analysis, prediction pipelines, clinical strategies, and dataset evaluation. You need enough technical judgment to know when an approach is sound and when to push back.
• Maintain awareness of regulatory constraints. You don't need to be a regulatory expert, but you need to build products that work within GxP requirements and clinical data governance standards.

About You

• 10+ years of experience in tech delivery with progressively broader scope, including at least one role where you led product or technology strategy and were held accountable for business outcomes.
• Life sciences experience: You've built products in biotech, pharma, or a related industry. You understand the drug development lifecycle well enough to have informed opinions about where technology does and doesn't help. You've worked in an environment shaped by regulatory constraints and scientific uncertainty.
• Strategic product thinker: You define product direction based on business outcomes, not feature velocity. You've owned a product area where success was measured in terms the business cared about - time saved, decisions improved, cost reduced - not just user engagement or ship rate.
• AI fluency: You can evaluate AI/ML approaches, make build-vs-buy decisions on AI capabilities, and push your team to use AI where it creates real leverage. You've deployed or led the deployment of LLM-based or agentic systems in a professional context.
• Technical fluency: You can engage deeply with engineers and data scientists on approach, architecture, and trade-offs. You can evaluate whether an ML model is solving the right problem, whether a data pipeline is reliable enough, and whether an engineering approach will scale.
• Cross-functional leadership: You've led teams that included engineers, data scientists, and product managers. You know how to hire, develop, and hold people to high standards.
• Business fluency: You can discuss clinical trial design, asset valuation, regulatory strategy, and competitive dynamics with senior leaders without retreating to technical jargon. You've been in rooms where the conversation was about business decisions, not product decisions, and you contributed.
• Comfortable with ambiguity and autonomy: You are highly adaptable and curious. You've worked in early-stage companies, on transformation efforts or new initiatives where the scope was unclear and the playbook didn't exist. That energizes you rather than stalls you.
• Mission-driven: You care about getting medicines to patients faster. That's what this company exists to do, and it matters to you.

Total Compensation Range: $374,000 - $467,000

About the Position 

Formation Bio is building a best-in-class Procurement function to support our rapidly growing organization. We are looking for a high-ownership Buyer who can independently run sourcing initiatives and RFPs, drive operational excellence in our purchasing processes, and serve as a trusted partner to stakeholders across the company.

This role will primarily focus on day-to-day buying and sourcing activities, while also having the opportunity to take on category ownership (e.g., IT or other indirect categories) as the company scales. You will play a critical role in transitioning core procurement workflows,  including intake, vendor onboarding, and purchasing operations, into Procurement, helping to build scalable processes from the ground up.

This is an ideal role for someone with experience in project management, sourcing, or running RFPs who is excited to grow into a broader procurement career. You will partner closely with the Head of Procurement, who will focus on strategy and long-term process transformation, while you drive execution and operational excellence.

Responsibilities

• Own and independently run end-to-end sourcing events and RFPs, including requirements gathering, vendor identification, bid evaluation, negotiation support, and stakeholder communication
• Serve as the primary Buyer for assigned business units, managing purchase requests, vendor selection, and commercial coordination
• Become a subject matter expert in Zip and lead day-to-day administration and optimization of procurement workflows within the platform
• Partner with stakeholders across IT, G&A, Clinical, and other teams to ensure timely, compliant, and cost-effective purchasing
• Transition and operationalize key procurement processes (e.g., vendor onboarding, intake management, purchasing workflows) into Procurement
• Support and help execute a major P2P platform process improvement initiative, ensuring scalable design and strong adoption across the organization
• Develop category insights and potentially assume ownership of specific categories (e.g., IT) depending on business needs and growth trajectory
• Maintain documentation, playbooks, and SOPs to improve procurement consistency and scalability
• Track and report on sourcing metrics, cycle times, savings, and process performance

About You 

Relevant Experience:

• 3-5+ years of experience in procurement, strategic sourcing, project management, operations, consulting, or a related field
• Demonstrated experience running RFPs or managing structured vendor selection processes independently
• Experience working cross-functionally with technical and non-technical stakeholders
  Strong project management skills with the ability to manage multiple concurrent initiatives
  
  

You may also have:

• Experience implementing or administering procurement tools (Zip experience strongly preferred)
• Experience supporting or owning an indirect spend category such as IT, G&A, or professional services
  Experience in a high-growth startup or scaling environment
• Exposure to life sciences, biotech, pharma, or other regulated industries

What we’re looking for:

• A self-starter who is comfortable with ambiguity and building processes from scratch
  High ownership and accountability — you take initiatives from concept to completion
• Strong communication and stakeholder management skills
• Detail-oriented with strong operational discipline
• Excited to help build a modern, tech-enabled procurement function

Total Compensation Range: $101,000 - $132,500

About the Position

As a Senior Data Scientist - Medical Imaging at Formation Bio, you will lead our efforts to integrate advanced imaging analytics and AI into our drug development pipeline. In this role, you'll pioneer the application of computer vision and deep learning to medical imaging data (MRI, X-ray, CT, PET) to accelerate clinical trials and improve patient outcomes. You'll develop state-of-the-art models for automated image analysis, disease progression monitoring, and treatment response assessment. Working closely with clinical teams, radiologists, and drug development experts, you'll translate complex imaging data into actionable insights that drive key decisions across our portfolio. This position offers a unique opportunity to revolutionize how medical imaging is leveraged in pharmaceutical development while directly impacting patient care.

Responsibilities

• Lead the development of advanced deep learning models for medical image analysis, focusing on MRI and X-ray modalities for clinical trial applications
• Design and implement automated image processing pipelines for disease detection, segmentation, and quantification across multiple therapeutic areas
• Create innovative approaches for longitudinal image analysis to track disease progression and treatment efficacy in clinical trials, incl. AI-based biomarkers and surrogate endpoints
• Collaborate with clinical operations to integrate imaging AI solutions into trial protocols and workflows
• Partner with regulatory teams to ensure imaging biomarkers and AI models meet FDA standards for clinical trial endpoints
• Build scalable infrastructure for processing and analyzing large-scale medical imaging datasets from multi-site clinical trials
• Present imaging insights and model performance to executive leadership and external partners

About You

Required Qualifications 

• PhD in Computer Science, Biomedical Engineering, Medical Physics, or related field with focus on medical imaging
• 5+ years of post-PhD industry experience developing production-grade AI models for medical imaging applications
• Deep expertise in computer vision and deep learning architectures (CNNs, U-Net, Vision Transformers) for medical image analysis
• Proven track record with MRI and X-ray image analysis, including hands-on experience with DICOM standards and medical imaging software
• Strong programming skills in Python with expertise in PyTorch/TensorFlow and medical imaging libraries
• Demonstrated ability to collaborate with radiologists and clinical teams to translate medical insights into technical solutions
• Strong communication skills with proven ability to present complex imaging analytics to diverse stakeholders

Preferred Qualifications 

• Experience with regulatory submissions involving imaging endpoints or AI-based image analysis tools
• Experience with multi-modal imaging fusion and analysis (combining MRI, CT, PET data)
• Knowledge of clinical trial design and experience with imaging core lab operations
• Experience with federated learning or privacy-preserving techniques for medical imaging
• Understanding of radiomics and quantitative imaging biomarker development
• Experience with 3D image reconstruction and volumetric analysis

Total Compensation Range: $177,500 - $232,000

About the Position 

The Director of Business Development, Strategic Sourcing, will play a key role in identifying, evaluating, and managing early-stage assets and opportunities for Formation Bio's business development pipeline. This role will involve guiding potential opportunities from asset identification through to transaction closing, working closely with the business development team to identify outreach areas and drive deal flow within designated outreach regions.

Responsibilities

• Leading deal-by-deal opportunity/asset teams from asset identification to transaction close
• Collaborating with the BD team to identify target areas for outreach, focusing on strategic alignment with Formation Bio's goals
• Owning and managing one or more designated business development outreach areas (e.g., big pharma, biotech companies, designated therapeutics areas)
• Maximizing activity and ensuring high-quality deal flow in assigned outreach areas, developing a steady stream of opportunities
• Conducting initial triage of opportunities, evaluating potential deals before engaging the broader diligence team to ensure strategic fit
• Working cross-functionally with R&D, tech platform, and commercial teams to ensure smooth handoffs and successful transitions in the diligence process

About You 

The ideal candidate will have a strong scientific background paired with business acumen, ideally with experience in search and evaluation, venture, or business development. This role requires someone who can identify assets that would benefit from Formation Bio's tech-enabled development capabilities and build relationships across the biotech and pharmaceutical industries.

• PhD in biological science or MD with laboratory research experience strongly preferred.
• 3-7 years of post-degree experience, with a combination of scientific and business expertise
• Prior experience of biotech or pharmaceutical business development (search & evaluation), venture capital investing, or life sciences consulting is highly preferable. 
• Strong network within the biotech and pharmaceutical industries, with the ability to leverage contacts for sourcing early-stage assets; Enthusiastic about networking, relationship building, and externally-facing activities
• An outgoing, motivated, and creative approach to business development
• Curiosity and insight around the role of AI in drug development, clinical trials, and business development

This role offers the opportunity to help build the pharma company of the future, combining strategic asset acquisition with tech-enabled development capabilities to bring new treatments to patients faster and more efficiently.

Total Compensation Range: $228,000 - $310,000

About the Position 

Formation Bio is seeking a bold and forward-thinking Vice President of Engineering to lead and transform our technical capabilities into a strategic driver of clinical and commercial success. This critical leadership role will report to the CTO and serve as a senior thought partner in defining how sophisticated engineering and computational frameworks can fundamentally reshape drug development and asset acquisition.

The ideal candidate is a biotech-native technical leader who understands that our goal is not to build traditional software products, but to develop deep technical capabilities that drive hard insights. You will partner closely with Product to translate complex scientific and operational bottlenecks into high-leverage technology solutions that accelerate workflows and deliver higher-quality insights. You will oversee the engineering behind complex data science analyses - including Real-World Evidence (RWE) platforms, large-scale information ingestion pipelines, and comprehensive modeling - that move the needle for pharma decision-making. You bring the vision and [biotech] experience to ensure our technical foundation supports clinical-stage assets and highly regulated R&D workflows with precision and speed.

Responsibilities

• Define and execute a technical vision that prioritizes high-leverage computational capabilities over traditional software features, ensuring engineering effort directly increases drug asset quality and value.
• Act as a core collaborator for the CTO and leadership team, translating complex clinical and business bottlenecks into scalable engineering solutions.
• Embed engineering resources within Business Development, Clinical, and R&D units to leverage technology to address operational needs.
• Partner with Data Science to build the engineering architecture required for complex analysis, including Real-World Evidence (RWE) platforms, asset screening frameworks, and prediction pipelines.
• Collaborate with Product to build specialized tools that streamline R&D workflows, moving the needle from manual efforts to technology-augmented insight generation.
• Develop and scale proprietary platforms for the ingestion and operationalization of external, clinical, and biological datasets.
• Ensure the delivery of GxP-validated clinical environments and automated security compliance, maintaining a regulatory-first posture without sacrificing speed.
• Deploy and scale LLM-integrated features and autonomous agents to drive multiplier efficiencies across the organization.
• Manage and mentor a specialized engineering organization, fostering a high-performance culture that values technical rigor, interdisciplinary collaboration, and mission-driven delivery.
• Refine the team structure to maintain high talent density and quality engineering in a fast-paced biotech environment.

About You 

• 10+ years of experience in software/data engineering and technical leadership, with a significant background in the Boston biotech or pharma-tech ecosystem.
• Biotech Intuition: You have likely been a VP of Engineering at 2–3 different biotechs and possess a deep understanding of the drug development lifecycle, from Discovery through Phase III.
• Proven People Leader: Experience managing and mentoring a team of 15+ engineers, with a track record of driving results in highly technical, interdisciplinary environments.
• Capability mindset: You understand that we aren't building a "user app"; we are building an engine for insights. You are passionate about the backend engineering required for RWE, data science, and trial automation.
• Engineering Rigor: Deep expertise in building data ingestion pipelines and managing complex, heterogeneous biological and clinical datasets.
• Regulatory Fluency: Experience working within GxP (GCP, GLP, GMP) environments. You know how to build technical capabilities that are "regulatory-ready" from day one.
• Strategic Partner: You are comfortable discussing risk-adjusted NPV, asset-level ROI, and clinical trial bottlenecks with CEOs, CMOs, and investors.
• Mission-Driven: Passionate about using hard engineering to solve the drug development bottleneck and bring life-changing treatments to patients faster.

Total Compensation Range: $347,000 - $435,000

About the Position 

Formation Bio is seeking an experienced and innovative Senior Director of Clinical Pharmacology to join our Development team. In this role, you will lead our clinical pharmacology efforts, supporting late-stage drug development and contributing to business development activities. You will play a crucial role in advancing our mission to bring new treatments to patients faster and more efficiently through our innovative, tech-enabled drug development platform.

The role reports to the VP of Translational Medicine and you will be a key member of the Formation Bio Development team.

Responsibilities

• Develop clinical pharmacology strategy consistent with the target product profile, program goals and regulatory strategy
• In collaboration with the Clinical Development team, define biopharmaceutics and clinical pharmacology studies needed to support NDA and drug label
• Lead clinical pharmacology activities   in supporting late-stage drug development programs across multiple therapeutic areas
• Design and oversee the execution of clinical pharmacology studies to support clinical development and regulatory submissions
• Determine scope, design, plan and analyze Phase 1-IV PK and PD studies, including development of appropriate population PK models.
• Contribute clinical pharmacology expertise to due diligence efforts for potential in-licensing opportunities
• Serve as the primary Clin Pharm lead and effectively participate in cross-functional teams to ensure integration of modern clinical pharmacology principles into project plan and study design
•  integrated development strategies
• Provide scientific leadership in interactions with regulatory agencies and external partners
• Develop and implement innovative approaches to enhance the efficiency and effectiveness of clinical pharmacology studies
• Manage resources, timelines, and budget for clinical pharmacology activities
• Mentor and develop the clinical pharmacology team, fostering a culture of scientific excellence and innovation
• Represent Formation Bio's clinical pharmacology capabilities at scientific conferences and partner meetings
• Prepare Clinical Pharmacology Section of regulatory documents, including INDs, NDAs, and briefing documents

About You 

• PhD or PharmD in Clinical Pharmacology or a related field with at least 15 years of experience in the biopharmaceutical industry, and a minimum of 10 years in a supervisory role in conduct and/or oversight of clinical pharmacology
• Proven track record in leading clinical pharmacology efforts in late-stage drug development
• Strong understanding of regulatory requirements for clinical pharmacology studies in support of clinical development
• Competent in the use of PK and PK/PD modeling software tools
• Experience in due diligence activities for in-licensing opportunities
• Excellent communication and leadership skills
• Ability to work effectively in a fast-paced, cross-functional environment
• Innovative mindset and enthusiasm for leveraging technology in drug development

Total Compensation Range: $311,000 - $388,500

About the Position 

The Associate Director, Bioanalytical will lead bioanalytical strategy and delivery for assigned programs, working across nonclinical and clinical teams to ensure assays are fit for purpose and support key development decisions. The role will oversee external bioanalytical partners and drive execution for PK/TK, metabolites as applicable, biologics bioanalysis, and immunogenicity, including assay approach selection, validation strategy, sample analysis oversight, data review, and submission-ready documentation. In partnership with Clinical Pharmacology, DMPK/Nonclinical, Clinical Operations, Regulatory, and data teams, this role will help scale Formation Bio’s Trial Engine by standardizing bioanalytical workflows, improving traceability, and enabling consistent, analysis-ready bioanalytical outputs across programs.

Responsibilities

• Lead bioanalytical strategy and delivery for assigned programs across small molecules and biologics, aligned to clinical questions and decision points
• Define assay plans and validation approaches (fit-for-purpose through full validation) for PK/TK, metabolites as applicable, biologics bioanalysis, and immunogenicity
• Manage bioanalytical CROs and specialty labs for assigned workstreams: contribute to partner selection, define scopes, set timelines, and monitor performance, quality, and budget
• Oversee end-to-end bioanalytical execution: protocols, validation reports, sample analysis, data review, and final reports to support program decisions and filings
• Own day-to-day BA operating processes for assigned programs: assay lifecycle tracking, method transfer planning, issue triage, deviation management, and CAPA follow-up with vendors
• Ensure data quality and audit readiness for assigned deliverables through strong documentation practices, traceability, and alignment to regulatory guidance and internal standards
• Partner with Clinical Pharmacology and Clinical Development on study design inputs, sampling strategies, analyte panels, and interpretation of exposure and immunogenicity implications
• Coordinate with Clinical Operations on sample logistics (kits, handling, stability, chain of custody, reconciliation) and resolution of operational issues impacting bioanalysis
• Collaborate with Regulatory Affairs by drafting/reviewing submission components and providing technical input to support IND/CTA and NDA/BLA/MAA activities
• Align with DMPK/Nonclinical on bioanalytical approaches across studies and support translational PK needs
• Work with Biostatistics/Data Science to enable clean data transfers, consistent formats/metadata, and analysis-ready datasets
• Support diligence and asset evaluation by reviewing bioanalytical packages, identifying gaps/risks, and proposing pragmatic remediation plans
• Contribute to Trial Engine scaling by helping standardize templates, workflows, and reporting conventions that improve speed and consistency across programs

About You 

• PhD in a relevant field with 7+ years of bioanalytical experience in biopharma, including clinical-stage support, or a relevant undergraduate degree with 10+ years of experience
• Lead bioanalytical strategy and execution for assigned preclinical and clinical programs across small molecules and biologics
• Deep LC–MS/MS expertise for PK/TK, troubleshooting, and ISR
• Familiar with biologics bioanalysis and immunogenicity (ADA/NAb) approaches and interpretation
• Strong working knowledge of bioanalytical regulatory expectations and submission-quality documentation
• Lead CRO/vendor execution for assigned workstreams; support partner selection and governance as needed
• Comfortable operating in a fast-paced, cross-functional environment with multiple concurrent priorities
• Clear communicator who can translate technical detail into program-relevant recommendations
• Preferred: Experience functioning as part of a clinical study team to integrate tradeoffs between vendor selection, development speed, assay quality and performance, and applicability of method to deliver value to program overall
• Preferred: Familiarity with GCP/GCLP expectations and audit/inspection readiness for clinical bioanalysis
• Preferred: Experience shaping sample logistics (kits, stability, chain of custody) and data flow into filings

Total Compensation Range: $177,500 - $232,000

About the Position

As a Principal Data Scientist - Medical Imaging at Formation Bio, you will lead our efforts to integrate advanced imaging analytics and AI into our drug development pipeline. In this role, you'll pioneer the application of computer vision and deep learning to medical imaging data (MRI, X-ray, CT, PET) to accelerate clinical trials and improve patient outcomes. You'll develop state-of-the-art models for automated image analysis, disease progression monitoring, and treatment response assessment. Working closely with clinical teams, radiologists, and drug development experts, you'll translate complex imaging data into actionable insights that drive key decisions across our portfolio. This position offers a unique opportunity to revolutionize how medical imaging is leveraged in pharmaceutical development while directly impacting patient care.

Responsibilities

• Lead the development of advanced deep learning models for medical image analysis, focusing on MRI and X-ray modalities for clinical trial applications
• Design and implement automated image processing pipelines for disease detection, segmentation, and quantification across multiple therapeutic areas
• Create innovative approaches for longitudinal image analysis to track disease progression and treatment efficacy in clinical trials, incl. AI-based biomarkers and surrogate endpoints
• Collaborate with clinical operations to integrate imaging AI solutions into trial protocols and workflows
• Partner with regulatory teams to ensure imaging biomarkers and AI models meet FDA standards for clinical trial endpoints
• Build scalable infrastructure for processing and analyzing large-scale medical imaging datasets from multi-site clinical trials
• Present imaging insights and model performance to executive leadership and external partners

About You

Required Qualifications 

• PhD in Computer Science, Biomedical Engineering, Medical Physics, or related field with focus on medical imaging
• 5+ years of post-PhD industry experience developing production-grade AI models for medical imaging applications
• Deep expertise in computer vision and deep learning architectures (CNNs, U-Net, Vision Transformers) for medical image analysis
• Proven track record with MRI and X-ray image analysis, including hands-on experience with DICOM standards and medical imaging software
• Strong programming skills in Python with expertise in PyTorch/TensorFlow and medical imaging libraries
• Demonstrated ability to collaborate with radiologists and clinical teams to translate medical insights into technical solutions
• Strong communication skills with proven ability to present complex imaging analytics to diverse stakeholders

Preferred Qualifications 

• Experience with regulatory submissions involving imaging endpoints or AI-based image analysis tools
• Experience with multi-modal imaging fusion and analysis (combining MRI, CT, PET data)
• Knowledge of clinical trial design and experience with imaging core lab operations
• Experience with federated learning or privacy-preserving techniques for medical imaging
• Understanding of radiomics and quantitative imaging biomarker development
• Experience with 3D image reconstruction and volumetric analysis

Total Compensation Range: $204,500 - $267,000

About the Position 

The Senior Director, Medical Affairs is a first-in-function leadership role responsible for building and leading Medical Affairs capabilities across Formation Bio’s growing portfolio. This role will establish the scientific foundation for programs spanning late-stage development to commercialization, with an initial focus on our lead asset, Sprifermin.

This leader will serve as a strategic scientific partner to Clinical Development, Regulatory, Commercial, and Portfolio teams, ensuring that Medical Affairs strategy, scientific exchange, and evidence generation are embedded early and executed with rigor, compliance, and credibility.

The Senior Director will design scalable medical affairs infrastructure, lead external scientific engagement, and build a high-impact Medical Affairs team—including the future build-out of a field-based Medical Science Liaison (MSL) team.

Responsibilities

Medical & Scientific Strategy

• • Lead medical affairs and scientific strategy across assigned programs, from late development through pre-launch and commercialization readiness.
  • Embed medical perspective early in development planning, including endpoint selection, evidence generation, and lifecycle strategy.
  • Provide medical and scientific input into asset diligence, in-licensing evaluations, and portfolio strategy.

External Scientific Engagement

• • Develop and execute a comprehensive KOL engagement strategy, building durable relationships with external experts, investigators, and scientific leaders.
  • Lead scientific exchange activities, including advisory boards, congress strategy, and external data communication.
  • Serve as a credible scientific leader representing Formation Bio programs externally with rigor and integrity.

Publications & RWE

• • Own publication planning and execution, ensuring timely, compliant dissemination of clinical and real-world data.
  • Support Phase IV, real-world evidence (RWE), and observational studies in partnership with Clinical and internal stakeholders.
  • Translate evidence into clear medical narratives that inform development, access, and launch readiness.

Medical Affairs Build-Out

• • Establish scalable medical affairs processes, governance, and operating models appropriate for a multi-asset organization.
  • Build and lead the Medical Affairs function over time, including the planned launch and management of a field-based Medical Science Liaison (MSL) team.
  • Balance internal capabilities with external vendors and partners to maximize efficiency and impact.

Launch & Cross-Functional Partnership

• • Support launch readiness through medical education strategy, scientific positioning, and internal training.
  • Provide medical affairs input into value narratives, HEOR strategy, and reimbursement dossiers in collaboration with cross-functional teams.

Patient & Advocacy Engagement

• • Develop strategy for engagement with patient advocacy groups and medical societies to inform development, education, and access.

About You 

• 10+ years of experience in Medical Affairs and/or Clinical Development within biopharma or biotech, with increasing leadership responsibility.
• Advanced scientific or clinical degree (PhD, PharmD, MD, or equivalent) strongly preferred.
• Demonstrated experience developing and executing medical strategy across late development, pre-launch, and commercialization.
• Experience building or scaling medical affairs capabilities, including MSL teams.
• Deep understanding of medical compliance, scientific exchange regulations, and industry best practices.
• Strong cross-functional partner with experience working closely with Clinical, Regulatory, Commercial, and Portfolio teams.
• Track record of credible external engagement with KOLs, investigators, and scientific stakeholders.
• Exceptional communication skills with the ability to synthesize complex data into clear strategic insights.
• Hands-on leadership style with comfort operating in a fast-growing, resource-lean environment.

Total Compensation Range: $325,000 - $425,000

About the Position

Formation Bio is looking for a Senior Manager to join its Brand & Communications team, reporting directly to the Head of Brand & Communications. This is a broad, high-ownership role for someone who wants to work across the full scope of a modern brand and communications function — internal comms, external brand initiatives, events, drug program communications, and brand operations — at a company doing something genuinely new in the world and therefore with a brand new story to tell.

To succeed, you must have a track record of excellent taste, pristine execution, seamless coordination, and operational excellence. You will own several workstreams end-to-end and support others, serving as a reliable, high-judgment partner to the Head of Brand & Communications across everything the function touches.

We're looking for someone who is extremely plugged into the tech and AI conversation, who instinctively understands how ideas travel, what's resonating, and where Formation Bio should show up. You bring intense enthusiasm for AI innovation and automation, and believe communications can be deeply human while leveraging AI to drive efficiency and scale. You'll be instrumental in helping build an AI-native communications function that fits squarely into Formation's broader mission and culture.

Responsibilities

Internal Communications 

• Own the end-to-end execution of internal communications rituals, including All Hands, Town Halls, written pass-downs, and strategic updates — from logistics and prewires through to post-event follow-up and action tracking
• Maintain the internal comms calendar and ensure the organization stays consistently informed
• Ideate, test, and launch meaningful new internal communications rituals to increase employee connectivity and alignment

Brand Initiatives 

• Support planning and execution of external brand initiatives — investor events, conferences, branded experiences, and our presence in the broader pharma and AI industry conversation — coordinating logistics, vendors, and cross-functional stakeholders to deliver polished, on-brand experiences
• Collaborate with the People team on talent brand workstreams, including content creation and events
• Partner with our Sr. Manager, Content on various forms of content (written, video, web, social, etc.) to drive forward brand goals 
• Support external PR + Comms work related to our pipeline drug assets, ranging from internal cross functional coordination to working on external op-eds, events, patient and policy initiatives

Brand Operations 

• Maintain and evolve internal brand resources, including guidelines, design libraries, tools, and norms, so every team can represent Formation Bio accurately and confidently
• Build and improve AI-powered systems and workflows that increase the speed, consistency, and quality of output across the communications function
• Serve as an internal resource on brand standards, helping employees across functions use brand assets correctly and effectively

About You

• 6+ years of experience in brand, communications, product marketing, or a related field, with broad exposure across internal and external workstreams
• Exceptional communicator and compelling writer, able to draft clearly and quickly across formats, both at a high level and in the weeds
• Deeply fluent in the tech and AI landscape — you follow the conversation closely, have strong opinions about it, and can identify where and how a company like Formation Bio fits in
• Background in product marketing is a plus — you understand how to translate complex, technical ideas into enticing narratives for distinct audiences
• A proven track record of using AI tools in day-to-day work and a clear vision for building more — you see this as a core part of the job, not a bonus skill
• Highly organized and high-ownership, with a track record of managing multiple workstreams simultaneously and driving them to completion with minimal supervision
• Collaborative and resilient, you thrive cross-functionally, stay grounded when priorities shift, and see ambiguity as an invitation to be creative
• Experience running high-touch branded experiences is a strong plus
• Experience at a startup or small tech company is strongly preferred, particularly candidates who have built programs and processes from scratch on short timelines
• Curiosity or experience in life sciences, biotech, health-tech, longevity, techbio, or AI for health

Total Compensation Range: $154,500 - $202,000

About the Position 

As a Data Scientist on the platform prediction team, you'll translate our probability of success predictions into measurable portfolio-level outcomes. You'll architect core systems — order management, execution simulation, portfolio construction, risk monitoring, and performance attribution — that let us rigorously evaluate signals from our AI-driven predictions in public and private equities and our internal portfolio.

This role sits at the intersection of quantitative finance, healthcare data, and AI-driven drug development. If you're excited about applying portfolio construction and risk management fundamentals to one of the most consequential prediction problems in healthcare, this is the role.No other company — hedge fund or pharma — has a technical data science position translating drug development experience into durable AI-native portfolio strategies. The skills you develop here — portfolio construction over assets with radically asymmetric risk profiles, clinical trial analytics, AI/ML in production, and risk management across multi-year horizons — can directly impact the delivery of new and effective therapeutics to patients by best aligning impactful medicines with economic incentives.

Responsibilities

• Work with the team to implement and maintain core portfolio engine: order management system, execution simulation layer, portfolio construction service, and performance tracking
• Design risk frameworks that quantify exposure across a portfolio of drug development bets with radically different risk profiles, timelines, and failure modes
• Run rigorous backtesting experiments with strict temporal constraints to evaluate Formation strategies against baseline approaches and measure marginal signal from new evidence sources
• Coordinate across the organization to integrate internal Formation data sources (clinical trial data, genomic evidence, real-world data) and proprietary tooling into portfolio analytics pipelines
• Work with product and engineering teams to build dashboards and reporting that communicate portfolio performance, risk metrics, and strategy comparisons to both technical and executive stakeholders
• Collaborate with the broader data science team to ensure portfolio-level evaluation feeds back into model improvement and evidence prioritization

About You 

Required Qualifications

• MS or PhD in a quantitative field (statistics, finance, physics, computational science, engineering, or related)
• 1-3 years in a quantitative research, data science, or analytics role — finance, healthcare, academic research, or consulting all count; substantive internships qualify
• Strong Python programming skills with experience in data-intensive workflows (pandas, numpy, scipy)
• Solid grasp of core portfolio construction and risk concepts: position sizing, rebalancing, Sharpe ratio, drawdown, volatility, benchmark comparison
• Demonstrated ability to work with messy, real-world datasets — comfortable with data wrangling, deduplication, and quality assessment
• Clear communicator who can present quantitative results to both technical peers and business stakeholders

Preferred Qualifications

• Experience with backtesting frameworks or portfolio simulation (vectorbt, Backtrader, or custom implementations)
• Exposure to healthcare, pharma, or biotech data (clinical trials, claims data, -omics, real-world evidence)
• Familiarity with alternative data in a research or investment context
• Experience with probability-of-success modeling, drug development decision analysis, or health economics
• Comfort with LLMs or AI/ML pipelines in a production or research setting
• Familiarity with dashboard/visualization tools (Streamlit, Plotly, Dash) and pipeline orchestration (Dagster, Airflow)

Healthcare OR finance domain knowledge is valued; both are not required.

Total Compensation Range: $154,500 - $202,000

About the Position

We're looking for a Data Engineer to join the Scientific Data Intelligence (SDI) team at Formation Bio to help build and scale the data infrastructure that powers our drug development platform. In this role, your primary focus will be supporting the Data Science team — building the coherent, well-structured data models, feature engineering pipelines, and evidence layers that underpin their scientific work. You'll also be responsible for ingesting data from a wide variety of sources—APIs, files, databases, and licensed third-party datasets—and transforming it into clean, analytics-ready assets using modern data tooling.

This is a foundational engineering role for someone who takes pride in building things right: reliable pipelines, well-structured data models, and systems that others can trust and build on. You'll work closely with Data Scientists and other engineers across the SDI team to ensure that high-quality data is consistently available where and when it's needed — and structured in a way that directly accelerates scientific discovery.

The ideal candidate is deeply fluent in Snowflake and dbt, has strong opinions about data modeling best practices, and has experience handling large and complex datasets across diverse ingestion patterns. You thrive in environments where data quality and engineering rigor are treated as first-class concerns.

Responsibilities

• Partner closely with Data Scientists and other teams to build coherent data models, feature engineering pipelines, and structured evidence layers that directly support scientific analysis and machine learning workflows.
• Design and build scalable ingestion pipelines to onboard data from diverse sources including REST APIs, flat files, relational databases, and licensed third-party datasets.
• Develop and maintain robust data models in dbt, adhering to best practices around modularity, testing, documentation, and layered architecture (staging, intermediate, mart).
• Orchestrate pipelines using Dagster to ensure reliable, observable, and maintainable workflows.
• Implement data quality checks, validation frameworks, and monitoring to ensure trustworthiness of datasets across the platform.
• Collaborate with Data Scientists and analysts to understand data needs and translate them into well-structured, reusable models.
• Handle large-scale data movement and transfer scenarios, applying appropriate tooling and patterns to ensure efficiency and reliability at scale.
• Document data models, pipeline logic, and transformation assumptions to support discoverability and data governance.

About You

• You have 5+ years of experience in data engineering, with a strong track record of building and maintaining production-grade pipelines.
• You are deeply fluent in dbt and follow best practices rigorously—including modular model design, sources and refs, testing (schema + data), documentation, and environment management.
• You have hands-on expertise with Snowflake, including schema design, performance tuning, and data governance patterns.
• You have experience with at least one modern orchestration tool—we use Dagster, but experience with Airflow or Prefect is equally welcome.
• You have broad ingestion experience across source types: REST APIs, flat files (CSV, JSON, Parquet), relational databases, and vendor-licensed datasets.
• You have worked with large datasets (TB -> PB scale) and understand the engineering considerations that come with scale—partitioning, incremental loading, efficient data movement, and storage optimization.
• You're a strong data modeler who thinks carefully about how data is structured, named, and layered for downstream usability.
• You value documentation, testability, and building things others can maintain and extend.
• You can balance upfront design with speed to execution, slowing down when it counts without getting stuck in the details.
• Bonus: You have experience with data quality and observability tooling such as Elementary, Great Expectations, or similar frameworks — and you treat data quality as a first-class engineering concern, not an afterthought.
• Bonus: You have experience with Spark, Databricks for large-scale data processing workloads.
• Bonus: You have experience with large-scale data transfer tooling such as AWS DataSync, AWS S3 Transfer Acceleration, or equivalent cloud-native data movement services.
• Bonus: You have experience in healthcare or life sciences data environments, including familiarity with EHR, claims, or other biomedical datasets.

Total Compensation Range: $177,500 - $232,000

About the Position 

The Associate Director, Drug Substance, Biologics, will provide technical, strategic and hands-on operational leadership for all CMC activities related to drug substance development and manufacturing, with a primary focus on Biologics at all stages of development (IND-enabling to commercialization).

The Associate Director, Drug Substance, will be responsible for overseeing the process development, manufacturing and release of drug substances at CDMOs ensuring manufacturing operations align with program timelines, quality standards, and regulatory requirements. This position requires deep expertise in biologics drug substance manufacturing (either cell culture or downstream purification), strong technical problem-solving abilities, and proven experience managing complex manufacturing operations with external partners. You will play a critical role in accelerating our mission of bringing new treatments to patients faster and more efficiently.

Responsibilities

Development and Manufacturing Strategy, Operations and Oversight

• • Lead drug substance manufacturing strategy and execution for programs from preclinical through commercial stages, ensuring alignment with program objectives, timelines, and budget constraints.
  • Serve as the primary technical interface with CDMOs for drug substance manufacturing activities. Establish and maintain strong partnerships, lead technical discussions, and ensure manufacturing excellence across external manufacturing network.
  • Oversee cell culture and downstream purification activities related to process development and manufacturing for both microbial and mammalian expression systems. Ensure manufacturing processes are robust, scalable, and compliant with cGMP requirements.
  • Provide technical guidance and oversight for manufacturing campaigns including batch record review and approval, deviation investigations, change control assessments, and resolution of manufacturing issues
  • Support scale-up activities from clinical to commercial manufacturing, including process optimization and validation. Identify and implement continuous improvement opportunities.
  • Develop comprehensive manufacturing plans and schedules in collaboration with Project Management, Clinical Supply, and Commercial teams. Track manufacturing timelines and proactively manage risks to ensure on-time delivery of drug substance for clinical trials and commercial supply.
  • Lead technical assessments and qualification of new CDMOs for drug substance manufacturing. Conduct site audits and ongoing performance monitoring. Manage relationships with multiple manufacturing partners across different geographic regions

Additional Core CMC Responsibilities (Quality, Regulatory & Cross-Functional)

• • Ensure all manufacturing activities comply with cGMP regulations, ICH guidelines, and internal quality standards. Support regulatory inspections and audits at manufacturing sites. Review and approve batch records, protocols, and manufacturing-related documentation.
  • Author and review CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing, process validation, and manufacturing site changes. Support responses to health authority questions.
  • Partner closely with Drug Product Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Clinical Supply, and Program Management leads to ensure seamless integration of manufacturing activities into overall program execution.
  • Collaborate with procurement to ensure timely contracting for drug substance manufacturing.

About You 

• MS or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related discipline.
• 6+ years of experience in the biopharmaceutical industry with hands-on experience in biologics drug substance manufacturing (either cell culture or downstream purification)
• Demonstrated track record of successfully managing drug substance manufacturing campaigns for biologics (proteins, monoclonal antibodies, antibody-drug conjugates, or other large molecules) from preclinical through late-stage clinical or commercial manufacturing.
• Technical expertise in either cell culture or downstream purification for process development, manufacturing, process characterization and process validation for biologics.
• Extensive experience working with CDMOs, including site selection, technology transfers, manufacturing oversight, and performance management. Proven ability to troubleshoot complex manufacturing issues and drive continuous improvement initiatives.

Total Compensation Range: $185,000 - $235,000

About the Position 

Formation Bio is looking for a Director of People Operations & Total Rewards to own the strategy and execution of our people infrastructure. 

Reporting to the SVP, Head of People, you'll drive outcomes that advance company priorities by building compensation expertise in-house, designing scalable people programs, and ensuring operational excellence across our systems and processes. This is a high-impact role for someone who can make independent, complex decisions with a company-wide perspective by evaluating tradeoffs in compensation strategy, benefits design, and program implementation while anticipating long-term implications for our unique business model.

We're looking for someone who brings genuine enthusiasm for AI innovation and automation. Someone who believes people operations can be deeply human while leveraging AI to drive efficiency and scale. You'll be instrumental in building an AI-native people function that reflects Formation's broader mission and culture.

Responsibilities

This role will cover three key areas critical to the success of the People function and business:

People Operations Excellence

• Drive AI-native operations across the people function - identifying opportunities to leverage technology while maintaining the human elements of our work
• Ensure compliance and evolve our people processes to ensure they are fit for purpose as the business scales
• Lead cross-functional processes and partner with internal stakeholders including Legal, Finance, Tech Ops, and Quality Assurance
• Serve as escalation point for complex operational issues, benefits decisions, and compensation situations
• Manage external vendor relationships and consultant partnerships

Total Rewards Strategy & Execution

• Own compensation strategy and execution for Formation's unique business model, including framework design, market positioning, and equity programs
• Lead benefits strategy, vendor selection, and plan design; ensuring our total rewards package is competitive and supports our culture and business needs
• Own cyclical compensation reviews end-to-end
• Partner on complex offer negotiations and provide market intelligence and competitive positioning recommendations

Program Design & Strategic Execution

• Elevate and own our annual performance, promotion and compensation review process to ensure quality, consistency, and scalability as we grow
• Partner with Director, People Business Partner on program execution and continuous improvement
• Anticipate program needs based on business growth and evolution

About You 

• 8+ years of experience in people operations, total rewards, and/or HR leadership roles 
• Deep compensation expertise - you've designed frameworks, led market analysis, structured equity programs, and can think strategically about total rewards in complex or unique business models
• Proven track record implementing AI and automation - you have concrete results in people operations, not just enthusiasm, and a strong vision for where an AI-native function can go
• Strong operational background - you've owned people systems, benefits, compliance, and built scalable people operations infrastructure
• Experience designing and scaling talent management programs - you know how to balance quality with operational efficiency
• Ability to make independent, complex decisions - you evaluate tradeoffs with a company-wide perspective and anticipate long-term implications
• Strong ownership mentality and high accountability - you take full responsibility for outcomes and drive work to completion
• People management experience - you've developed and elevated individuals and teams, and care deeply about career development
• Strong cross-functional partnership skills - you build excellent relationships with internal teams and external vendors
• Comfortable working in fast-paced, high-growth environments - you can be both strategic and hands-on
• Experience in biotech, pharma, or other technical/regulated industries is a plus but not required

Total Compensation Range: $185,500 - $267,000

About the Position

We're looking for a Senior Data Engineer to join the Scientific Data Intelligence (SDI) team at Formation Bio to help transform Real World Data (RWD)—spanning electronic health records, claims, and other longitudinal patient data sources—into structured, analytics-ready assets. In this role, you'll be partnering closely with our Data Science team not only to model and transform data, but also to actively analyze it: answering research questions, generating evidence, and supporting scientific decision-making across our drug portfolio.

This position sits at the intersection of healthcare data engineering, real-world evidence analysis, and generative AI. While a strong foundation in building reliable, scalable pipelines is essential, you'll be equally expected to roll up your sleeves and work directly with the data—constructing cohorts, running analyses, and translating findings into actionable insights for scientific and business stakeholders.

The ideal candidate is a hybrid of data engineer and applied scientist: someone who can build the infrastructure and then use it, with familiarity in RWD study design, GenAI fluency (e.g., LLM-based entity extraction, summarization, classification), and strong technical expertise with modern data tooling. You'll play a key role in shaping how real-world patient data becomes discoverable, structured, and impactful across the organization.

Responsibilities

• Model and transform raw EHR and claims data into clean, canonical, and analytics-ready datasets using SQL, Python, and clinical standards like OMOP.
• Build and manage scalable data pipelines using Dagster for orchestration, dbt for transformation, and Snowflake as the primary compute and storage engine.
• Conduct hands-on RWD analyses to answer scientific and strategic research questions—including disease epidemiology, treatment patterns, patient journey characterization, and comparative effectiveness.
• Partner with Data Scientists and clinical leads to design and execute observational studies, translating scientific questions into well-structured, reproducible analyses.
• Implement data validation, completeness, and observability frameworks to ensure real-world datasets are accurate, comprehensive, and trustworthy for downstream research and product use.
• Apply Generative AI techniques within transformation and analysis layers to accelerate data structuring and insight generation.
• Communicate findings clearly to both technical and non-technical stakeholders, including summaries for portfolio teams and leadership.

About You

• You have 5+ years of experience in data engineering, ideally with at least 2 years working in healthcare or life sciences, including direct exposure to EHR or claims datasets.
• You have experience with ontologies and biomedical schemas (e.g. UMLS, LOINC, ICD9/10, MeSH) and understand the modalities found within RWD — billing claims, lab results, visit notes.
• You're fluent in SQL and Python, and you've built and maintained production-grade pipelines that support analytics or scientific workflows.
• You have experience building longitudinal patient cohorts from EHR or claims data, including index date logic, washout periods, and follow-up window construction.
• You have a solid understanding of the causal inference frameworks such as potential outcomes and target trial emulation. 
• You have working familiarity with real-world evidence study design concepts—such as active comparator new user designs, time-to-event outcomes, confounder adjustment, and causal discovery algorithms—sufficient to partner effectively with Data Scientists on causal inference workflows.
• You value clarity, documentation, and structured thinking—especially when working with complex healthcare data.
• You have hands-on expertise with modern data infrastructure, such as Snowflake, dbt, and Dagster.
• You can balance upfront design with speed to execution, slowing down when it counts without getting stuck in the details.
• Bonus: You've worked in regulated or privacy-sensitive data environments and are familiar with governance models for PHI or sensitive data.
• Bonus: You have prior experience working with commercial RWD vendors (e.g. Truveta, Optum, Komodo, IQVIA) and understand the nuances of licensed claims and EHR datasets, including longitudinal patient journey construction and line-of-therapy sequencing.

Total Compensation Range: $204,500 - $267,000

About the Position

Formation Bio is seeking a highly skilled and experienced Senior Director, Biostatistics to join our dynamic team. This critical role will report to the Head of Biometrics and will be responsible for leading and developing the biostatistics team and strategy, driving impactful statistical initiatives, and leveraging biostatistics to advance our drug development processes.

The Senior Director, Biostatistics will play a key role in shaping innovative trial designs, supporting regulatory strategies, and ensuring high-quality statistical contributions across clinical development. They will also collaborate cross-functionally to integrate advanced analytics, data-driven decision-making, and AI applications into our development programs to improve efficiency and increase the probability of success.

Responsibilities

• Strategic Leadership: Lead and develop the Biostatistics team, fostering a high-performance culture aligned with Formation Bio’s mission and values. Provide mentorship and career development to ensure team growth and expertise.
• Statistical Strategy & Innovation: Drive statistical strategy across clinical development programs, incorporating optimal trial designs, simulation-based approaches, and AI/ML applications to enhance efficiency and decision-making. Guide clinical and regulatory strategies to optimize trial design and maximize the probability of success.
• Study Design & Execution: Provide expert statistical input into clinical study design, endpoint selection, analysis planning, and regulatory interactions. Explore innovative trial design options to identify the most effective clinical development strategy that aligns with business needs and optimizes decision-making. Ensure study designs are scientifically rigorous, operationally feasible, and aligned with regulatory expectations. Leverage AI-driven clinical trial automation to enhance study execution, optimize resource allocation, and improve trial efficiency.
• Regulatory & Cross-Functional Collaboration: Partner with Clinical, Data Science, Regulatory, and Business Development teams to support drug diligence, development and regulatory interactions, FDA briefing books, and submission-related activities. Represent Biostatistics in key regulatory meetings (e.g., FDA, EMA) to ensure statistical rigor in clinical development plans.
• Operational Excellence: Establish and refine statistical workflows, SOPs, and best practices to improve efficiency, quality control, and compliance with industry standards.
• Data-Driven Decision-Making: Champion data-driven approaches and quantitative decision-making frameworks, integrating scenario analyses and statistical trial simulations to optimize clinical trial execution and strategic development plans.
• External Engagement: Stay at the forefront of industry trends and regulatory expectations, representing Formation Bio in scientific discussions, conferences, and collaborations.
• Vendor & CRO Management: Oversee and manage statistical vendors, including consulting statisticians and CROs, ensuring high-quality statistical deliverables and compliance with GCP and regulatory standards.

About You

• Ph.D. in Biostatistics, Statistics, or a related field with 10+ years of experience in biostatistics within the pharmaceutical or biotech industry, statistical consulting firms, or CROs supporting clinical development.
• Proven experience leading biostatistics teams and strategies within clinical development.
• Deep expertise in statistical trial designs, adaptive designs, Bayesian methods, and simulation-based approaches for both early and late-stage development.
• Strong understanding of regulatory guidelines for drug development, including FDA and EMA requirements for statistical practice, regulatory submissions, and health authority interactions.
• Experience in quantitative decision-making frameworks to support internal Go/No-Go decisions. 
• Demonstrated track record of leading statistical contributions to progress assets from diligence, early development through regulatory submissions and approvals.
• Ability to collaborate cross-functionally with Clinical, Data Management, Programming, Data Science, Regulatory, and other teams.
• Strong problem-solving skills with the ability to balance scientific rigor with operational efficiency.
• Excellent communication skills, with the ability to convey complex statistical concepts into actionable insights for non-statisticians, senior management, and regulatory agencies.
• Proficiency in SAS, R (S-Plus), and statistical software for sample size calculations (e.g., East, PASS, NQuery). Expert R programming skills are a plus.
• Passion for innovation, AI-driven methodologies, and data-driven decision-making in clinical development.

Total Compensation Range: $311,000 - $385,000

About the Position 

We are seeking a highly motivated, self-driven and detail-oriented Associate Director of Analytical Development and Quality Control to join our CMC team.  This role will provide broad exposure across Formation Bio’s portfolio, requiring the ability to flex between small molecule and biologics programs at different phases of development in an outsourced development model, requiring strong technical skillset, vendor management, and the ability to balance scientific rigor with program timelines.

You will play a key role in providing technical leadership as a subject matter expert for the development, optimization, and validation of drug substance and drug product analytical methods to support outsourced development and manufacturing of small molecule and biologics programs including but not limited to proteins, monoclonal antibodies, and vaccines. In this role you will also oversee all Formation Bio stability programs and closely collaborate with CMC, QA, and Regulatory teams.

Responsibilities

• In close collaboration with CDMOs and contract testing laboratories, lead development, optimization and validation of phase-appropriate analytical methods for small molecule and biologics drug substances and drug products.
• Manage testing (in-process, release, stability) at CDMOs and contract testing laboratories.
• Provide technical oversight for method transfers, comparability assessments, and laboratory readiness.
• Lead selection, qualification, and ongoing performance management of external analytical vendors.
• Oversee and manage Formation Bio’s stability studies across all programs, including review and approval of stability protocols and review and trending of stability data to support shelf-life and retest dating. Track and publish stability program metrics. Act as the primary contact for stability-related inquiries.
• Oversee and manage Formation Bio’s critical reagents and reference standards inventory and testing.
• Lead investigations of release and stability OOS and OOT results, deviations, CAPAs and change controls.
• Author and review analytical sections of CMC documents, including protocols, reports, and regulatory submissions.
• Author and review of SOPs and work instructions.
• Closely collaborate with CMC, QA, and Regulatory teams.

About You 

• Analytical Chemistry, Biochemistry, Molecular Biology, or a related discipline Master’s degree with 5+ years or Bachelor’s Degree with 8+ years of relevant small molecule and biologics analytical development and QC experience.
• Proven ability to operate effectively in a fast-paced, virtual, and outsourced development environment.
• Highly organized with a track record of managing multiple priorities across programs in an outsourced development model.
• Strong scientific judgment with the ability to independently assess data quality, identify risks, and recommend mitigation strategies.
• Ability to communicate complex analytical concepts clearly to both technical and non-technical stakeholders.
• Collaborative mindset with a strong sense of ownership and accountability.
• Extensive hands-on experience developing, optimizing, and validating analytical methods for release and stability testing of small molecules and biologics.
• Hands-on experience with analytical methods pertinent to bilogics (qPCR, IEF, UHPLC, MS, CE, SDS-PAGE, ELISA, peptide mapping, glycan analysis, etc.) and small molecules (UHPLC, IC, GC, IR, UV, KF, PSD, dissolution, etc.).
• Experience with authoring and reviewing technical documents such as test methods, method development reports, validation protocols, validation reports, specification justification reports, retest and shelf-life memos, and SOPs.
• Experience with designing stability studies and performing stability data trending according to applicable guidances.
• Strong working knowledge of Smartsheet and JMP.
• Thorough understanding of ICH, FDA, EMA guidances and GMP requirements governing process development, manufacturing, and stability.
• Ability to travel domestically and internationally up to 25% of the time. 

Total Compensation Range: $177,000 - $235,000

About the Position

As the Director of Data Science at Formation Bio, you will be at the forefront of revolutionizing drug development through AI and advanced analytics. In this role, you'll lead crucial initiatives that directly impact our drug development portfolio, from developing sophisticated models for patient selection to creating AI-powered solutions for clinical trial optimization. You'll work at the intersection of computational biology, machine learning, and drug development, collaborating with cross-functional teams to translate complex biological data into actionable insights. This position offers a unique opportunity to shape the future of pharmaceutical development by leveraging cutting-edge AI technologies while making a meaningful impact on patient lives. 

Responsibilities

• Lead and execute complex data science projects that directly advance our drug development portfolio 
• Develop and implement sophisticated models for therapeutic hypothesis evaluation, including patient stratification and biomarker identification
• Design and create AI models for modernizing clinical trial evaluations, including surrogate endpoints 
• Aid in the development and training of AI agents to automate and optimize biomedical workflows 
• Collaborate cross-functionally with clinical, technical, and research teams 
• Present complex analytical findings to senior stakeholders, including executive leadership 

About You

Required Qualifications 

• PhD in computational sciences or life sciences 
• 7+ years of post-academic experience in life sciences (biotech, pharma, consulting) 
• Strong programming skills, particularly in Python 
• Extensive experience in multi-modal bioinformatics analysis 

Preferred Qualifications 

• Proven expertise in cloud computing environments, including proficiency with tabular and/or graph databases 
• Strong background in machine learning and deep learning, particularly in biological applications 
• Experience with large language models (LLM)
• Demonstrated ability to collaborate effectively with engineering teams on production systems
• Strong communication skills with proven ability to present complex technical findings to senior stakeholders 

Total Compensation Range: $235,000 - $307,000

About the Position

As a Principal Data Scientist at Formation Bio, you will be at the forefront of revolutionizing drug development through AI and advanced analytics. In this role, you'll lead crucial initiatives that directly impact our drug development portfolio, from developing sophisticated models for patient selection to creating AI-powered solutions for clinical trial optimization. You'll work at the intersection of computational biology, machine learning, and drug development, collaborating with cross-functional teams to translate complex biological data into actionable insights. This position offers a unique opportunity to shape the future of pharmaceutical development by leveraging cutting-edge AI technologies while making a meaningful impact on patient lives. 

Responsibilities

• Lead and execute complex data science projects that directly advance our drug development portfolio 
• Develop and implement sophisticated models for therapeutic hypothesis evaluation, including patient stratification and biomarker identification
• Design and create AI models for modernizing clinical trial evaluations, including surrogate endpoints 
• Aid in the development and training of AI agents to automate and optimize biomedical workflows 
• Collaborate cross-functionally with clinical, technical, and research teams 
• Present complex analytical findings to senior stakeholders, including executive leadership 

About You

Required Qualifications 

• PhD in computational sciences or life sciences 
• 5+ years of post-academic experience in life sciences (biotech, pharma, consulting) 
• Strong programming skills, particularly in Python 
• Extensive experience in multi-modal bioinformatics analysis 

Preferred Qualifications 

• Proven expertise in cloud computing environments, including proficiency with tabular and/or graph databases 
• Strong background in machine learning and deep learning, particularly in biological applications 
• Experience with large language models (LLM)
• Demonstrated ability to collaborate effectively with engineering teams on production systems
• Strong communication skills with proven ability to present complex technical findings to senior stakeholders 

Total Compensation Range: $204,500 - $267,000

About the Position 

The Associate Director, Drug Product, will provide strategic and hands-on operational leadership for all CMC activities related to drug product development and manufacturing, with a primary focus on sterile injectables (lyophilized and liquid) at all stages of development (IND-enabling to commercialization).

The Associate Director, Drug Product, will be responsible for overseeing the formulation development, fill-finish, packaging, and release of drug products at CDMOs ensuring manufacturing operations align with program timelines, quality standards, and regulatory requirements. This position requires deep expertise in biologics drug product manufacturing, strong technical problem-solving abilities, and proven experience managing complex manufacturing operations with external partners. You will play a critical role in accelerating our mission of bringing new treatments to patients faster and more efficiently.

Responsibilities

Development and Manufacturing Strategy, Operations and Oversight

• Lead drug product manufacturing strategy and execution for programs from preclinical through commercial stages, ensuring alignment with program objectives, timelines, and budget constraints.
• Serve as the primary technical interface with CDMOs and contract manufacturing organizations for drug product manufacturing activities. Establish and maintain strong partnerships, lead technical discussions, and ensure manufacturing excellence across external manufacturing networks.
• Oversee formulation, aseptic fill-finish, lyophilization (if applicable), visual inspection, labeling, and packaging operations for drug products. Ensure manufacturing processes are robust, scalable, and compliant with cGMP requirements.
• Provide technical guidance and oversight for manufacturing campaigns including batch record review and approval, deviation investigations, change control assessments, and resolution of manufacturing issues
• Support scale-up activities from clinical to commercial manufacturing, including process optimization and validation. Identify and implement continuous improvement opportunities.
• Develop comprehensive manufacturing plans and schedules in collaboration with Project Management, Clinical Supply, and Commercial teams. Track manufacturing timelines and proactively manage risks to ensure on-time delivery of drug product for clinical trials and commercial supply.
• Lead technical assessments and qualification of new CDMOs for drug product manufacturing. Conduct site audits and ongoing performance monitoring. Manage relationships with multiple manufacturing partners across different geographic regions

Additional Core CMC Responsibilities (Quality, Regulatory & Cross-Functional)

• Ensure all manufacturing activities comply with cGMP regulations, ICH guidelines, and internal quality standards. Support regulatory inspections and audits at manufacturing sites. Review and approve batch records, protocols, and manufacturing-related documentation.
• Author and review CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing, process validation, and manufacturing site changes. Support responses to health authority questions.
• Partner closely with Drug Substance Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Clinical Supply, and Project Management leads to ensure seamless integration of manufacturing activities into overall program execution.
• Collaborate with procurement to ensure timely contracting for drug product manufacturing.

About You 

• MS or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related discipline.
• 6+ years of experience in the biopharmaceutical industry with hands-on experience in biologics drug product manufacturing, formulation development, and fill-finish operations.
• Demonstrated track record of successfully managing drug product manufacturing campaigns for biologics (proteins, monoclonal antibodies, antibody-drug conjugates, or other large molecules) from preclinical through late-stage clinical or commercial manufacturing.
• Technical expertise in aseptic fill-finish operations, lyophilization processes, formulation development, stability programs, and drug product characterization for biologics.
• Extensive experience working with CDMOs and contract manufacturing organizations, including site selection, technology transfers, manufacturing oversight, and performance management. Proven ability to troubleshoot complex manufacturing issues and drive continuous improvement initiatives.
• Strong knowledge of cGMP regulations, FDA and EMA guidelines, ICH quality guidelines, and regulatory expectations for drug product manufacturing.
• Experience authoring and reviewing CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing and validation activities.
• Strong project management skills with demonstrated ability to manage multiple manufacturing programs simultaneously, meet aggressive timelines, and navigate competing priorities.
• Excellent communication and interpersonal skills with ability to influence and build strong relationships with internal stakeholders and external manufacturing partners.
• Willingness to travel domestically and internationally (approximately 20-30%) to manufacturing sites for audits, manufacturing oversight, and technical meetings.

Total Compensation Range: $177,000 - $235,000

About the Position 

We're hiring Software Engineers to help implement what engineering looks like at an AI-native pharma company. This is not a traditional SWE role and it's not an ML research role - it's for someone who builds production software in a world where AI has fundamentally changed what one engineer can do.

At Formation, the lines between engineering, product management, and data science are converging. Engineers talk directly to users, PMs write code, and domain experts across the company build and deploy real tools. We need engineers who thrive in that environment: people who move fast, care about the problem they're solving (not just the code), and see AI tools as a permanent force multiplier rather than a novelty.

You'll work across the drug development lifecycle - building systems that accelerate how we find, evaluate, develop, and deliver new medicines. You'll collaborate with clinical, regulatory, BD, and operations teams, not from behind a ticket queue, but embedded in the work. Some of what you build will be net-new products. Some will be infrastructure that enables non-engineers to build safely alongside you. All of it matters.

If you're energized by opportunity, and motivated by the idea that your work directly helps get medicines to patients faster, this is the role.

Responsibilities

• Design, build, and ship production software that accelerates drug development - from internal tools to user-facing products to platform capabilities.
• Use AI tools (LLMs, agentic coding systems, retrieval-augmented pipelines) as a core part of how you work, not as an experiment on the side.
• Get close to the business. Understand the clinical, regulatory, or operational problem you're solving well enough to make good product decisions without waiting for a spec.
• Build for composability. Clean APIs, structured schemas, machine-readable documentation - what you build needs to be discoverable and extensible by people and agents who aren't engineers.
• Review and enable contributions from non-engineers. PMs, designers, and domain experts across the company are shipping code. You help ensure quality, security, and maintainability.
• Build the guardrails that lift technical quality. Proactively create automated tools - security scanners, skill files for end users, agents that clean up and standardize non-engineer code - that raise the floor of quality across the entire organization without slowing anyone down.
• Prototype rapidly. Many ideas should be live and testable within days, not weeks. Build the tool, get feedback, iterate.
• Collaborate across engineering, data science, product, and domain teams - the boundaries between these functions are fluid here, and we expect you to operate across them.

About You 

• A track record of shipping production systems in ambiguous, fast-moving environments.
• You build with AI tools daily. Claude Code, Copilot, agentic workflows - whatever the best current tools are, you're already using them and have opinions about what works.
• Strong fundamentals: you write clean, maintainable code, you understand distributed systems and cloud infrastructure (AWS, GCP, or Azure), and you can debug hard problems.
• You're drawn to the problem space, not just the stack. You'd rather understand why a clinical operations team needs a tool than debate framework choices in isolation.
• Comfortable with ambiguity. You've worked in 0-to-1 settings or early-stage environments where the playbook didn't exist. That energizes you.
• Excellent communicator. You can explain technical trade-offs to non-technical stakeholders and align a room around a decision.
• Experience in pharma, biotech, or life sciences. Genuine curiosity about the domain.
• You want to operate at a higher tempo and a higher standard than you have before, and you want to be surrounded by people who hold themselves to the same bar.

Total Compensation Range: $204,500 - $267,000