Director of Bioanalytical Sciences

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.