Associate Director, Bioanalytical Development

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

Lead CRO/vendor execution for assigned workstreams; support partner selection and governance as needed

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

$167,000 - $230,000

Salary ranges are informed by a number of factors including geographic location. The range provided includes base salary only. In addition to base salary, we offer equity, comprehensive benefits, generous perks, hybrid flexibility, and more. If this range doesn't match your expectations, please still apply because we may have something else for you.

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.

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

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, Sam Altman, 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