Job Application for Associate Director, Bioanalytical Development at Formation Bio Back to jobs Associate Director, Bioanalytical Development 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 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
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 1-3 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 with MyGreenhouse 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... Where are you most excited for AI to help your function? * What AI tools have you used, whether in your personal or work life? * Are you located in or willing to relocate to NYC, Boston, San Francisco, or Research Triangle Park? * 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... 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 04/30/2026 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 Greenhouse
