Xaira Therapeutics

Director of Bioanalytical Sciences

South San Francisco, California, United States · Director

Sponsorship not specified$173k-$225kDetected 34 days ago

LLMsPharmacologyFDA RegulatoryFlow CytometryResearchExperimental DesignProtein AnalysisAnimal StudiesMentoring

About the role

About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development.
Xaira is headquartered in the San Francisco Bay Area, Seattle, and London.

Lead the development, optimization, qualification, and validation of ligand-binding assays (e.g., ELISA, MSD, ECL) and flow cytometry-based methods for PK, PD, receptor occupancy, and target engagement to support both non-GLP and IND-enabling GLP studies.
Direct the design and interpretation of DMPK and bioanalytical studies, integrating PK/PD and exposure data to support candidate selection and translational dose projection.
Serve as the primary technical and relationship lead for CRO partnerships - selecting, onboarding, and managing external labs
Author and review bioanalytical sections of regulatory documents (IND, IB, study reports) and ensure methods meet GLP and current FDA/EMA/ICH M10 bioanalytical method validation guidance.
Collaborate cross-functionally with discovery biology, protein sciences, pharmacology, toxicology, clinical, and regulatory teams to align bioanalytical endpoints with program goals.
As pipeline evolves, build and manage a focused internal team.
Serve as the primary technical and relationship lead for CRO partnerships - selecting, onboarding, and managing external labs; reviewing protocols, validation plans, and data packages; and ensuring on-time, high-quality deliverables.

More than 10 years of biotech/pharmaceutical industry experience in bioanalytical or DMPK development for biologics.
Deep expertise in bioanalytical method development, qualification, and validation for large molecules across human and preclinical species (NHP and rodent).
Demonstrated hands-on and strategic experience with PK, PD, and receptor occupancy assays, and with DMPK study design and interpretation.
Working knowledge of GLP and regulatory bioanalytical guidance (FDA, EMA, ICH M10).
Experience managing and mentoring staff scientists including in a matrixed environment.

Experience supporting IND filings and early clinical development for biologics.
Familiarity with platforms such as MSD/ECL, Gyrolab, Simoa, and multiparameter flow cytometry.
Experience integrating PK/PD modeling and translational data.
however, the base pay offered will vary depending on the market, job-related knowledge, skills and capabilities, and experience.
Xaira Therapeutics an equal-opportunity employer.
We believe that our strength is in our differences.
TO ALL RECRUITMENT AGENCIES: Xaira Therapeutics does not accept agency resumes.
Please do not forward resumes to our jobs alias or employees.

Collectively, these technologies aim to continually enable the identification of novel therapies and to improve success in drug development.

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers.
We offer a competitive package that includes base salary, bonus, and equity.
The base pay range for this position is expected to be $173,000 - $225,000 annually
however, the base pay offered will vary depending on the market, job-related knowledge, skills and capabilities, and experience.
Xaira Therapeutics an equal-opportunity employer. We believe that our strength is in our differences. Our goal to build a diverse and inclusive team began on day one, and it will never end.
TO ALL RECRUITMENT AGENCIES: Xaira Therapeutics does not accept agency resumes. Please do not forward resumes to our jobs alias or employees. Xaira Therapeutics is not responsible for any fees related to unsolicited resumes.

This listing is sourced directly from Xaira Therapeutics's careers page and normalized into a canonical job model.