Development Bioanalytical Leader; Director​/Senior Director​/Executive Director

JLSa2 is a recently launched seed-stage venture backed company located in South San Francisco focused on developing novel multifunctional protein-drug conjugate therapies to address human metabolic diseases and other non-oncology related diseases.

The Development Bioanalytical Leader, which reports into the Head of DMPK, is responsible for providing scientific, operational, and regulatory leadership for bioanalytical activities supporting the development of peptide biologic therapeutics from nonclinical development through late-stage clinical studies. This individual will oversee outsourced bioanalytical programs, including mass spectrometry and ligand binding assays supporting pharmacokinetics (PK), anti-drug antibody (ADA), immunogenicity, and biomarker analyses.

As the company's bioanalytical subject matter expert, this leader will develop and execute bioanalytical strategies that enable regulatory submissions and informed development decisions while working collaboratively across Toxicology, CMC, Clinical Pharmacology, Clinical Development, Regulatory Affairs, Quality, and external CRO partners.

• Develop and execute integrated bioanalytical strategies supporting nonclinical and clinical development programs. Provide scientific leadership for bioanalytical assays supporting pharmacokinetic /toxicokinetic (PK/TK), in vivo PK/PD studies, anti-drug antibody (ADA), immunogenicity, and other development bioanalytical endpoints. Define fit-for-purpose assay strategies across all stages of development, from non-GLP toxicology studies through Phase 1–3 clinical trials. Serve as the internal subject matter expert on development bioanalysis for peptide –conjugate and other biologic therapeutics.

• Lead all outsourced bioanalytical activities performed at contract research organizations (CROs). Select, qualify, and manage CRO partners to ensure high-quality, timely assay development, validation, sample analysis, and reporting. Review protocols, validation plans, study reports, and data packages for scientific quality and regulatory compliance. Monitor project timelines, budgets, deliverables, and operational performance. Troubleshoot technical and operational issues with CRO partners and implement appropriate corrective actions.

• Provide technical oversight of ligand binding assays (LBA) and LC-MS/MS methods for quantitative bioanalysis. Guide assay development, transfer, qualification, validation, and lifecycle management. Evaluate emerging technologies and recommend innovative bioanalytical approaches where appropriate. Interpret bioanalytical data and communicate findings to multidisciplinary project teams.

• Provide regulatory expertise for bioanalytical methods supporting INDs, CTAs, BLAs, and other global regulatory submissions. Ensure bioanalytical activities comply with FDA, EMA, ICH, and other applicable regulatory guidance and industry best practices. Author and review bioanalytical sections of regulatory documents, study reports, briefing books, and responses to regulatory agencies. Support inspections, audits, and quality investigations related to bioanalytical activities.

• Partner closely with Clinical Pharmacology, Toxicology, Clinical Operations, Regulatory Affairs, Biometrics, Quality Assurance, and Project Management. Contribute to clinical study design by ensuring appropriate bioanalytical sampling strategies and assay readiness. Present bioanalytical strategy, data, and recommendations to governance committees and senior leadership.

• Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, or a related scientific discipline. Minimum of 8 years of relevant bioanalytical experience within biotechnology, pharmaceutical, or CRO environments. Demonstrated expertise supporting development of peptide and biologic therapeutics. Extensive experience with ligand binding assays (LBA) and LC-MS/MS bioanalytical methods. Strong knowledge of pharmacokinetic (PK), anti-drug antibody (ADA), and immunogenicity assay development and validation. Experience supporting…