Xaira Therapeutics

1 month ago

Director of Bioanalytical Sciences

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 23 hours agoStatus: Live

Job Summary

Lead the bioanalytical strategy for a biologics portfolio across discovery to clinical stages, overseeing development, qualification, and validation of PK, PD, receptor occupancy, and related endpoints. Partner with CROs to deliver regulated data for candidate selection and IND-enabling programs, while building and mentoring an internal team in a fast-paced AI-enabled biotech environment.

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Executive & General Management

Seniority: Sr. Director level

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 to support PK, PD, receptor occupancy, and target engagement for 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; 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 guidance.

Key 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 — a must.

Experience:BiotechPharmaceuticalBioanalytical

Education:PhD / Doctorate

Skills:LeadershipCollaborationCommunicationStrategic thinkingMentoring

Languages:English

Tech Stack:ELISAMSDECLFlow cytometryGyrolabSimoa

Company Brief

Xaira Therapeutics

Xaira Therapeutics is a biotechnology company developing novel targeted therapeutics using proprietary discovery platforms to address serious unmet medical needs. The company focuses on advancing preclinical and clinical-stage programs toward regulatory approval and commercialization.

Industry: Biotech

Website

Loading job details...

Preparing the role view and application actions.

Xaira Therapeutics

1 month ago

Director of Bioanalytical Sciences

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 23 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Executive & General Management

Seniority: Sr. Director level

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 to support PK, PD, receptor occupancy, and target engagement for 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; 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 guidance.

Key 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 — a must.

Experience:BiotechPharmaceuticalBioanalytical

Education:PhD / Doctorate

Skills:LeadershipCollaborationCommunicationStrategic thinkingMentoring

Languages:English

Tech Stack:ELISAMSDECLFlow cytometryGyrolabSimoa

Company Brief

Xaira Therapeutics

Industry: Biotech

Website