Role Summary

We are seeking a Director of Bioanalytical Sciences to build and lead the bioanalytical strategy supporting our biologics portfolio across human and preclinical species, including non-human primate (NHP) and rodent models. This individual will be responsible for overseeing (both internally and externally) the development, qualification, and validation of bioanalytical methods spanning pharmacokinetics (PK), receptor occupancy (RO), and related biomarker and pharmacodynamic (PD) endpoints. As a key technical and strategic leader, the Director will partner extensively with contract research organizations (CROs) to deliver high-quality, regulatory-compliant data that informs candidate selection, translational strategy, and IND-enabling and clinical programs.

Key Responsibilities

• Define and execute the analytical bioassay strategy for biologic programs across discovery, preclinical, and clinical stages, with emphasis on human, NHP, and rodent species.
• 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; reviewing protocols, validation plans, and data packages; and ensuring on-time, high-quality deliverables.
• 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.
• Establish robust assay qualification and validation frameworks, including acceptance criteria, troubleshooting strategies, and lifecycle management.
• 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.

Required Qualifications

• PhD in immunology, biochemistry, pharmacology, analytical chemistry, bioengineering, or a related life-science discipline.
• 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.
• Strong, proven track record of partnering with and managing CROs to deliver regulated bioanalytical data — a must.
• Working knowledge of GLP and regulatory bioanalytical guidance (FDA, EMA, ICH M10).
• Experience managing and mentoring staff scientists including in a matrixed environment.

Preferred Qualifications

• 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.
• Prior experience building or scaling a bioanalytical function in a fast-paced or AI-enabled environment.

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. A Summary of Benefits is available for all applicants. 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.