Associate Director of Bioanalytical Development, Formation Bio
$177.5-232k
Offers equity
3+ days a week in office
End-to-end medical trial solutions
Open for applications
End-to-end medical trial solutions
101-200 employees
Open for applications
$177.5-232k
Offers equity
3+ days a week in office
101-200 employees
Company mission
To bring new treatments to patients faster and more efficiently.
Role
Who you are
- 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
Desirable
- 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
What the job involves
- 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
- 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
Our take
Clinical drug trials are lengthy and expensive, delaying the supply of vital new drugs to patients and costing lives. For Formation Bio, this is an efficiency issue - one which it hopes to solve with its end-to-end automation solution.
According to the company, its approach has teams running medical trials twice as fast and at half the cost. This success has pushed Formation to expand beyond supporting trials into developing assets itself. In 2025, it reached a major milestone by licensing its first drug in a deal worth up to hundreds of millions. Alongside this, the company has also added an early immunology program to its pipeline, signalling a broader push into in-house development.
Now a Unicorn, with partners including Pfizer, Sanofi, Novartis and 23andMe, Formation Bio is steadily embedding itself within the Big Pharma ecosystem. How far it can go remains an open question, but the prospect of cheaper drugs and faster innovation is becoming harder for the industry to ignore.
Kirsty
Company Specialist at Welcome to the Jungle
Insights
30% employee growth in 12 months
Company
Funding (last 2 of 3 rounds)
Jun 2024
$372m
SERIES D
Sep 2021
$156m
SERIES C
Total funding: $530.3m
Company benefits
- Flexible Time Off: We have a flexible PTO policy as we trust our team members to take the time they need to recharge.
- Parental Leave: We believe your personal life enriches your professional one. We offer 16 weeks of paid parental leave for birthing parents and 12 weeks for non-birthing parents so you can start or grow your family.
- Comprehensive Benefits: All full time employees have access to health, vision, and dental insurance. Additionally, we provide pre-tax commuter benefits, access to a 401k plan, short and long-term disability and life insurance.
- Education & Career Development Resources: Formation Bio offers a plethora of professional development resources to employees. Some examples include fireside chats with industry experts, conference passes, certification courses, internal mobility opportunities, in depth manager training, leadership coaching program, and more.
- Strategic Hiring Hubs: Formation Bio teams are hybrid and based in four key hubs: New York City, Boston, the San Francisco Bay Area, and North Carolina’s Research Triangle. Our bright and collaborative NYC headquarters is conveniently located near major transit hubs and stocked with drinks, coffee, snacks, and a weekly lunch.
- Community: Our teams collaborate closely to achieve our mission, supporting each other across functions and priorities. We build connection through team-building events, quarterly company gatherings, a company-wide retreat every two years, and Employee Resource Groups.
Company values
- Think in first principles: We rigorously interrogate all possible paths to understand how we can do things differently and faster. We challenge assumptions, ask why, and solve problems from the ground up
- Be a scientist: We are curious and we continuously learn. We steelman, not strawman in debates. We listen, rapidly iterate, and make the best decisions with the evidence we have
- Deliver care: We lead with empathy. We value different perspectives, collaborate across teams, and support one another. We give and receive direct, actionable and timely feedback to hold ourselves and others to a high bar
- Champion the mission: We keep the mission as our north star and deliver impact for patients. We hold ourselves accountable for our wins and failures and keep moving forward
Company HQ
Midtown South, New York, NY
Articles
Leadership
Benjamine Liu
(Co-Founder & CEO)Worked as a computational biologist at various Neurology departments, following a D.Phil in computational Biology and Psychiatry at Oxford. They are also an Advisor at Harvard Business School.
Linhao Zhang
(Co-Founder)Linhao is also the Founder of Foundation 649. Previously, they were a Product Engineer at Oscar Insurance, a Software Engineer at Salesforce, and co-founder of Day 7 Photography.
Dan Neil
(CTO)Prior to joining Formation Bio in 2025, Dan was the Chief Data Officer at Tessera Therapeutics. Before that, they spent nearly 7 years at BenevolentAI in various roles, including SVP of AI & NY Site Lead and CTO.
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