Xaira Therapeutics
Director of Bioanalytical Sciences
South San Francisco, California, United States · Director
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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.
Responsibilities
- 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.
- 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.
- Our goal to build a diverse and inclusive team began on day one, and it will never end.
Requirements
- 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.
Nice to have
- 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.
Skills
- Collectively, these technologies aim to continually enable the identification of novel therapies and to improve success in drug development.
Compensation
- 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.
Benefits
- A Summary of Benefits is available for all applicants.
This listing is sourced directly from Xaira Therapeutics's careers page and normalized into a canonical job model.