Development Bioanalytical Leader (Director / Senior Director / Executive Director)

Valid8 Financial, Inc.; South San Francisco (CA); On-site; USD 200,000 - 260,000; Full time

Job summary

Valid8 Financial, Inc. is seeking a Development Bioanalytical Leader to provide scientific, operational, and regulatory leadership for bioanalytical activities across peptide biologics from nonclinical through late-stage clinical studies.

The role oversees CRO partners, guides LC-MS/MS and LBA strategy, ensures FDA/EMA/ICH alignment, and collaborates with cross-functional teams to enable regulatory submissions and informed development decisions.

Qualifications

• PhD in Pharmaceutical Sciences required.
• 8+ years of bioanalytical experience in biotech/pharma/CRO.
• Expertise in peptide/biologic therapeutics and LBA/LC-MS/MS methods.

Responsibilities

• Develop and execute integrated bioanalytical strategies for nonclinical and clinical programs.
• Lead outsourced bioanalytical activities with CROs, ensure quality and regulatory compliance.
• Provide regulatory expertise for INDs, CTAs, BLAs, and MAAs and support inspections.

Skills

LBA methods

LC-MS/MS

PK/ADA knowledge

Regulatory submissions

Cross-functional leadership

External CRO mgmt

Education

Ph.D. in Pharmaceutical Sciences

Tools

Phoenix WinNonlin

Job description

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.

Bioanalytical Strategy

• 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.

Bioanalytical Operations & CRO Management

• 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.

Scientific Leadership

• 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.

Regulatory & Quality

• 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.

Cross-functional Collaboration

• 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.

Qualifications

• 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 bioanalytical activities from nonclinical development through clinical development.
• Strong understanding of current FDA, EMA, and ICH bioanalytical method validation guidance.
• Proven experience managing external CROs and outsourced development activities.
• Experience supporting regulatory submissions including INDs, CTAs, BLAs, or MAAs.
• Hands-on experience performing non-compartmental pharmacokinetic (NCA) analyses and interpreting PK parameters using industry-standard software (e.g., Phoenix WinNonlin) to support discovery and early development decision-making.
• Experience working in cross-functional, matrixed drug development teams.
• Strong organizational skills with the ability to manage multiple development programs simultaneously.
• Excellent written and verbal communication skills, including presenting to executive leadership and external partners.
• Highly collaborative and effective at influencing cross-functional teams without direct authority.
• Strategic thinker with the ability to balance scientific rigor, operational execution, and business priorities.

Salary Range: $200,000 to $260,000 (Compensation commensurate with experience/expertise/level and could fall outside of the stated range)