Associate Director, Bioanalytical Development

Formation Bio•Boston, MA

5h•Hybrid

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.

Requirements

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

Nice To Haves

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
Familiarity with GCP/GCLP expectations and audit/inspection readiness for clinical bioanalysis
Experience shaping sample logistics (kits, stability, chain of custody) and data flow into filings

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