Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Target Resume Now
About the Role
Xaira Therapeutics is seeking a Director of Bioanalytical Sciences to build and lead the bioanalytical strategy for its biologics portfolio. This role involves overseeing the development, qualification, and validation of bioanalytical methods for PK, RO, and biomarker endpoints, partnering with CROs to deliver high-quality, regulatory-compliant data.
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.
Requirements
- 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.
- 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.
- Prior experience building or scaling a bioanalytical function in a fast-paced or AI-enabled environment.
Skills
- Bioanalytical method development
- Bioanalytical method qualification
- Bioanalytical method validation
- Ligand-binding assays
- ELISA
- MSD
- ECL
- Flow cytometry
- Pharmacokinetics (PK)
- Receptor Occupancy (RO)
- Biomarker assays
- Pharmacodynamic (PD) endpoints
- DMPK study design
- DMPK study interpretation
- CRO management
- GLP compliance
- Regulatory document authoring
- IND filings
- MSD/ECL platforms
- Gyrolab
- Simoa
- Multiparameter flow cytometry
- PK/PD modeling
- Translational data integration
Location
- San Francisco Bay Area
- Seattle
- London
Work Type
- Full-time
Experience Level
- Director
- 10+ years industry experience
Education Level
- PhD
Salary/Compensations
- $173,000 - $225,000 annually
Benefits
- Competitive compensation and benefits package
- Open, flexible, and friendly work environment
- Platform for long-term career development
- Base salary
- Bonus
- Equity
About the Company
- Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development.
- The company is leading the development of generative AI models to design protein and antibody therapeutics, enabling the creation of medicines against historically hard-to-drug molecular targets.
- It is also developing foundation models for biology and disease to enable better target elucidation and patient stratification.
- Collectively, these technologies aim to continually enable the identification of novel therapies and to improve success in drug development.
Equal Opportunity
- 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.