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Back to jobs Director/Senior Director of Asset Quality Assurance Boston, MA; New York, NY Apply About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others. You can read more at the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently. About the Position Formation Bio is an AI native Biotech company running drug development programs, and the Quality function here is built to match that operating model: lean, risk-calibrated, and embedded in asset decisions from day one. You will not be maintaining a compliance bureaucracy; you will be designing quality frameworks that accelerate programs rather than slow them down. This is a rare seat at the table where quality strategy directly shapes how assets move forward and get to patients. Responsibilities Embed Quality by Design (QbD): Partner with asset development teams upstream to integrate Quality by Design principles into clinical, nonclinical, and CMC development plans, including those leveraging AI-enabled technology and real-world data. Risk & Opportunity Mapping: Proactively identify meaningful quality risks and opportunities within assigned Asset Pods and collaborate with technical and strategic subject matter experts to establish fit-for-purpose control and mitigation strategies. In-Licensing & Asset Due Diligence: Assess the quality health of external target assets during due diligence, including data quality and reliability, compliance risks, and vendor footprint. Acquisition & Commercial Readiness: Drive the audit-readiness strategy to ensure assets transition seamlessly from development toward commercial launch or out-licensing. Regulatory & Audit Intelligence: Interpret and apply global regulatory expectations (FDA, EMA, ICH) in digital and AI-accelerated environments, applying first-principles thinking to build fit-for-purpose, lean compliance frameworks for asset development and commercialization. About You You have a proven ability to influence and lead cross-functional Asset Pods and senior stakeholders without direct operational authority. You apply first-principles thinking to bypass rigid compliance mentalities in favor of risk-benefit-based, agile problem solving. You are fluent working with data-driven teams and comfortable leveraging automation and digital tools to maximize data value and process efficiency. You have deep knowledge of the critical transitions an asset makes between preclinical and clinical phases through commercial or acquisition readiness, with well-rounded GxP proficiency across GLP, GCP, and GMP. You have demonstrated skill in conducting quality due diligence assessments for R&D and early-stage clinical assets, and a deep understanding of requirements for commercialization inspections, product launch, and post-approval commitments. You hold a bachelor’s or advanced degree in a scientific, engineering, or related discipline, with extensive multidisciplinary GxP experience in biopharma quality assurance leadership, ideally within a fast-paced biotech that has successfully transitioned from early-stage to commercial. You have a proven track record of managing program-level risk management frameworks and successfully leading assets through major regulatory inflection points and strategic transactions. Total Compensation Range: Director $177,500 - $232,000; Senior Director $235,000 - $307,000 Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply! Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate. Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. Get new jobs like this in your inbox We'll email you when Formation Bio posts a job like this one. Create alert Apply for this job * indicates a required field Autofill my application First Name* Last Name* Email* Phone Country* Phone* Location (City)* Locate me Resume/CV* Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf LinkedIn Profile Are you legally authorized to work in the United States?* Select... Are you located in or willing to relocate to NYC, NY or Boston, MA?* Select... What AI tools have you used, whether in your personal or work life?* Where are you most excited for AI to help your function?* If hired by Formation Bio, will you now or in the future require sponsorship for employment visa status (e.g. H-1B, TN, OPT, etc)?* Select... How did you hear about this job?* Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Formation Bio’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. Gender Select... Are you Hispanic/Latino? Select... Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Select... Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 07/31/2029 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp. How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete. Submit application Powered by

Listed by Formation Bio for a position based in the United States. Employers on this board attest they are hiring domestically.

Bio + Health

132 days ago

Associate Director, Data Science (Real World Data)

Formation Bio · Boston, MA

Pay

$214k–267k

Setting

On-site

Apply Sign in to favorite Permalink

Back to jobs Associate Director, Data Science (Real World Data) Boston, MA; New York, NY Apply About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others. You can read more at the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently. 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: $213,500 - $267,000 Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply! Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate. Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. Get new jobs like this in your inbox We'll email you when Formation Bio posts a job like this one. Create alert Apply for this job * indicates a required field Autofill my application First Name* Last Name* Email* Phone Country* Phone* Location (City)* Locate me Resume/CV* Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf LinkedIn Profile How did you hear about this job? Have you previously worked in drug development?* Select... Are you legally authorized to work in the United States?* Select... If hired by Formation Bio, will you now or in the future require sponsorship for employment visa status (e.g. H-1B, TN, OPT, etc)?* Select... Are you within 60 miles commutable distance to our midtown Manhattan office or the Downtown Boston area?* Select... If you are not located within commuting distance from one of our hubs, are you willing to relocate? Select... What AI tools have you used, whether in your personal or work life?* What is your highest level of education* Select... Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Formation Bio’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. Gender Select... Are you Hispanic/Latino? Select... Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Select... Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 07/31/2029 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp. How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete. Submit application Powered by

Listed by Formation Bio for a position based in the United States. Employers on this board attest they are hiring domestically.

Engineering

135 days ago

Software Engineer (Open Level)

Formation Bio · New York, NY

Pay

$204k–267k

Setting

On-site

Apply Sign in to favorite Permalink

Back to jobs Software Engineer (Open Level) New York, NY; Boston MA; San Francisco, CA Apply About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others. You can read more at the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently. 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 Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply! Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate. Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. Create a Job Alert Interested in building your career at Formation Bio? Get future opportunities sent straight to your email. Create alert Apply for this job * indicates a required field Autofill my application First Name* Last Name* Email* Phone Country* Phone* Location (City)* Locate me Resume/CV* Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Education School* Select... Degree* Select... Add another LinkedIn Profile* Are you legally authorized to work in the United States?* Select... If hired by Formation Bio, will you now or in the future require sponsorship for employment visa status (e.g. H-1B, TN, OPT, etc)?* Select... Are you located in or willing to relocate to NYC, Boston, San Francisco, or Research Triangle Park?* Select... What AI tools have you used, whether in your personal or work life?* Where are you most excited for AI to help your function?* How many years of industry experience do you have?* Select... Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Formation Bio’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. Gender Select... Are you Hispanic/Latino? Select... Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Select... Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 07/31/2029 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp. How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete. Submit application Powered by

Listed by Formation Bio for a position based in the United States. Employers on this board attest they are hiring domestically.

Product Management

135 days ago

Senior Director or Vice President, Product

Formation Bio · New York, NY

Pay

$270k–353k

Setting

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Back to jobs Senior Director or Vice President, Product New York, NY; Boston MA Apply About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others. You can read more at the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently. 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: Senior Director: $270,000-$353,000; Vice President: $374,000 - $467,000 Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply! Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate. Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. Create a Job Alert Interested in building your career at Formation Bio? Get future opportunities sent straight to your email. 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Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Formation Bio’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. Gender Select... Are you Hispanic/Latino? Select... Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. 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