Full-Time
Associate Director
Bioanalytical Development
Formation Bio
51-200 employees
AI-driven platform accelerates clinical-stage drug development
Compensation Overview
$177.5k - $232k/yr
Boston, MA, USA + 1 more
More locations: New York, NY, USA
Hybrid
Three days in the office per week are required. Applicants must reside in, or be willing to relocate to, the listed hiring hubs.
Bachelor's, PhD
 Biology & Biotech (1) |
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- A PhD in a relevant field with 7 or more years of bioanalytical experience in biopharma, including clinical-stage support, or a relevant undergraduate degree with 10 or more years of experience.
- Experience leading bioanalytical strategy and execution for assigned preclinical and clinical programs across small molecules and biologics.
- Deep liquid chromatography–tandem mass spectrometry expertise for pharmacokinetics, toxicokinetics, troubleshooting, and incurred sample reanalysis.
- Familiarity with biologics bioanalysis and immunogenicity approaches, including anti-drug antibody and neutralizing antibody interpretation.
- Strong working knowledge of bioanalytical regulatory expectations and submission-quality documentation.
- Experience leading contract research organization and vendor execution for assigned workstreams, including supporting partner selection and governance.
- Ability to operate in a fast-paced, cross-functional environment with multiple concurrent priorities.
- Ability to translate technical detail into program-relevant recommendations.
- 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, from fit-for-purpose through full validation, for pharmacokinetics, toxicokinetics, metabolites, biologics bioanalysis, and immunogenicity.
- Manage bioanalytical contract research organizations and specialty laboratories by contributing to partner selection, defining scopes, setting timelines, and monitoring performance, quality, and budget.
- Oversee end-to-end bioanalytical execution, including protocols, validation reports, sample analysis, data review, and final reports supporting program decisions and filings.
- Own day-to-day bioanalytical operating processes for assigned programs, including assay lifecycle tracking, method transfer planning, issue triage, deviation management, and corrective and preventive action follow-up with vendors.
- Ensure data quality and audit readiness through documentation practices, traceability, and alignment with 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, including kits, handling, stability, chain of custody, reconciliation, and resolution of operational issues impacting bioanalysis.
- Collaborate with Regulatory Affairs by drafting and reviewing submission components and providing technical input for IND/CTA and NDA/BLA/MAA activities.
- Align with DMPK/Nonclinical on bioanalytical approaches across studies and support translational pharmacokinetic needs.
- Work with Biostatistics and Data Science to enable clean data transfers, consistent formats and metadata, and analysis-ready datasets.
- Support diligence and asset evaluation by reviewing bioanalytical packages, identifying gaps and risks, and proposing remediation plans.
- Contribute to Trial Engine scaling by helping standardize templates, workflows, and reporting conventions.
- Work as part of a clinical study team to integrate tradeoffs among vendor selection, development speed, assay quality and performance, and method applicability.
- Familiarity with Good Clinical Practice and Good Clinical Laboratory Practice expectations and audit or inspection readiness for clinical bioanalysis.
- Experience shaping sample logistics, including kits, stability, chain of custody, and data flow into filings.
Formation Bio uses an AI-driven platform to speed up drug development by focusing on clinical-stage assets. It acquires and advances these assets using flexible financing structures, aiming to shorten timelines and cut costs for bringing new drugs to market. The core product is the proprietary AI tools that help with drug selection, development planning, and improving overall efficiency, enabling partnerships and successful commercialization with pharmaceutical and biotech companies. Compared with competitors, Formation Bio combines a data-powered approach with adaptable financing and asset acquisition strategies to move assets forward quickly and cost-effectively. The goal is to make treatments more accessible and affordable by accelerating development and enabling faster, more predictable commercialization through AI-enhanced decision making and flexible funding options.
Company Size
51-200
Company Stage
Series D
Total Funding
$530.3M
Headquarters
New York City, New York
Founded
2013
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Simplify's Take
What believers are saying
- June 2025 Series D raised $372 million, supporting pipeline expansion and platform buildout.
- June 2026 BLKR201 entered Phase 1 five months after in-licensing, showing execution speed.
- Formation Bio licensed IMIDomics anti-CD226 and Lynk BLKR201, broadening autoimmune assets.
What critics are saying
- BLKR201 is first-in-human only; failure before early-2027 readout would damage platform claims.
- Formation Bio depends on partners like Sanofi, Lynk, and IMIDomics for pipeline supply.
- If gusacitinib or BLKR201 disappoint, the company becomes an expensive asset-flipping story.
What makes Formation Bio unique
- Formation Bio pairs AI trial design with asset acquisitions and in-licensing.
- Sanofi and OpenAI partnered with Formation Bio in June 2025 on AI drug development.
- Michael Ehlers joined July 2026, adding Biogen and Pfizer R&D credibility.
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Growth & Insights and Company News
6 month growth
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↑ 0%Formation Bio has appointed Michael D. Ehlers as Chief Scientific Officer and Head of R&D. Ehlers will oversee portfolio strategy and advancement, from translational sciences through clinical development, and guide the scientific direction of Formation Bio's AI platform. Ehlers joins from MPM BioImpact, where he was an Entrepreneur Partner. He previously served as Executive Vice President of R&D at Biogen and held senior positions at Pfizer. Throughout his career, programmes under his leadership have produced six approved drugs spanning five indications and four drug modalities, with more than 40 programmes advanced into the clinic. Formation Bio is an AI-native pharma company that acquires clinical-stage assets and accelerates them through development using its proprietary AI platform.
NEW YORK, June 9, 2025 /PRNewswire/ -- Formation Bio, an AI-driven pharmaceutical company focused on accelerating drug development, today announced the appointment of its first class of Entrepreneurs in Residence (EIRs): Kia Motesharei, Ph.D., Minji Kim Ph.D, MBA, John Taylor, M.S., and Anthony S. Walsh, D.Phil, These seasoned dealmakers will work closely with Chief Business Officer David Steinberg to expand the company's business development capabilities and further its mission to bring high-potential treatments to patients faster. Formation Bio acquires and in-licenses promising drug assets, advancing them through critical development milestones (Phase II and beyond), and then out-licensing for further advancement. The company's AI platform supports this lifecycle end-to-end—from asset identification and development strategy to execution of clinical trials aimed at greater speed and higher probability of success
TrialSpark dba Formation Bio has filed a notice of an exempt offering of securities to raise $372,000,000.00 in New Equity Investment. TrialSpark dba Formation Bio has filed a notice of an exempt offering of securities to raise $372,000,000.00 in New Equity Investment.According to filings with the U.S. Securities and Exchange Commission, TrialSpark dba Formation Bio is raising up to $372,000,000.00 in new funding. Sources indicate that as part of senior management Chief Executive Officer, Benjamine Liu played a key role in securing the recent investment and it will aid in aggressively expanding the company, as well as broaden and accelerate product development.About TrialSpark dba Formation BioFormation Bio is a tech-driven pharmaceutical company differentiated by radically more efficient drug development. Formation Bio has built a technology platform that optimizes critical aspects of clinical drug development, enabling more efficient trial design, faster trial completion, and higher quality trial data. The company acquires clinical-stage drugs from pharmaceutical and biotech companies with the goal to develop them faster in order to accelerate access to new treatments for patients, and to unlock greater value per program.To learn more about TrialSpark dba Formation Bio, visit http://www.formation.bio/TrialSpark dba Formation Bio Linkedin Page: https://www.linkedin.com/company/formationbio/Contact:Benjamine Liu, Chief Executive Officer866-283-7544https://www.linkedin.com/in/benjamine-liu-54306518/SOURCE: http://www.intelligence360.ioCopyright (c) 2024 SI360 Inc
Formation Bio, a NYC-based tech-driven and AI-native pharma company, raised $372M in Series D funding
What You Should Know:– Sanofi, a global pharmaceutical leader, Formation Bio, an AI-powered drug developer, and OpenAI, a leading research and development company in artificial intelligence, have announced a groundbreaking collaboration. The first-of-its-kind partnership in the pharma and life sciences industries aims to leverage AI to accelerate drug development and bring new medicines to patients faster.– Sanofi, Formation Bio, and OpenAI believe this collaboration will be a game-changer in the pharmaceutical industry. By combining their expertise in data, AI technology, and drug development, they aim to revolutionize the way new medicines are discovered and brought to market.A Symphony of ExpertiseThe collaboration will combine the unique strengths of each partner:Sanofi: Will contribute proprietary data for building custom AI models, furthering their goal of becoming the first biopharma company powered by AI at scale. This data will be crucial for training and refining the AI tools used in drug discovery.Will contribute proprietary data for building custom AI models, furthering their goal of becoming the first biopharma company powered by AI at scale. This data will be crucial for training and refining the AI tools used in drug discovery. OpenAI: World-renowned for its advancements in AI technology, OpenAI will contribute access to cutting-edge AI capabilities