Job Title: Associate Director, Bioanalytics

Location: Thousand Oaks, CA or San Francisco, CA

Position Type: VP, Translational Science

Position Type: Full Time

Position Description:

Latigo is seeking an experienced and highly motivated Associate Director, Bioanalytics to lead bioanalytical activities supporting discovery, nonclinical, and clinical development programs. This individual will provide strategic and operational leadership for bioanalytical assay development, validation, and sample analysis activities conducted through external CRO partners and internal collaborators.

The successful candidate will serve as the bioanalytical subject matter expert across multiple programs and will work closely with Clinical Pharmacology, Biomarkers, Toxicology, DMPK, Clinical Operations, Regulatory Affairs, and Quality teams to ensure delivery of high-quality bioanalytical data that support key development decisions and regulatory submissions.

The ideal candidate will possess deep expertise in ligand binding assays, LC-MS/MS methodologies, biomarker assay platforms, and regulatory expectations for bioanalytical method validation. Experience supporting both small molecule and biologic drug development programs is desirable.

Key Responsibilities:

Bioanalytical Strategy & Leadership

• Develop and execute bioanalytical strategies to support discovery, nonclinical, and clinical development programs.
• Serve as the bioanalytical lead on cross-functional project teams.
• Contribute to overall development strategy, timeline planning, and risk assessment activities.

CRO and Vendor Management

• Identify, select, and manage CROs and laboratory service providers.
• Oversee bioanalytical method development, qualification, validation, transfer, and sample analysis activities.
• Review study plans, protocols, validation reports, and analytical data packages.
• Ensure timely delivery of high-quality data and compliance with project timelines and budgets.

Regulatory & Quality Compliance

• Ensure bioanalytical activities are conducted in accordance with GLP, GCP, and applicable regulatory guidance.
• Author and review bioanalytical sections of regulatory submissions, including INDs, CTAs, briefing packages, IBs, and NDAs.
• Support regulatory agency interactions and responses related to bioanalytical methodologies and data.
• Collaborate with Quality Assurance to oversee inspections, audits, deviations, investigations, and CAPAs.

Data Review & Interpretation

• Collaborate with Clinical Pharmacology, DMPK, and Biomarker teams to integrate bioanalytical findings into study and program assessments.
• Present results and recommendations to project teams, senior leadership, and external stakeholders.

Team Collaboration & Development

• Establish strong partnerships across Research, Development, Clinical, Regulatory, and CMC functions.
• Mentor junior scientists and contribute to the growth of bioanalytical capabilities within the organization.
• Foster a culture of scientific excellence, accountability, collaboration, and continuous improvement.

Qualifications

Education

• D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Molecular Biology, Pharmacology, or a related scientific discipline with 8+ years of relevant industry experience; or
• S. degree with 12+ years of relevant industry experience; or
• S. degree with 15+ years of relevant industry experience.

Experience

• Significant bioanalytical experience supporting drug discovery and development for small molecule programs in the biotechnology or pharmaceutical industry.
• Demonstrated expertise managing outsourced bioanalytical activities.
• Extensive experience with LC-MS/MS methodologies for small molecule quantitation.
• Strong understanding of FDA, EMA, and ICH bioanalytical method validation guidance.
• Experience supporting regulatory filings and interactions.
• Proven ability to influence cross-functional teams and manage multiple programs simultaneously.

Preferred Qualifications

• Experience supporting Phase 1 through Phase 3 clinical studies.
• Experience with pain, neuroscience, ion channel, or CNS drug development programs.

Core Competencies

• Strategic thinking and scientific leadership
• Strong project management and organizational skills
• Excellent written and verbal communication abilities
• Collaborative and team-oriented mindset
• Sound judgment and decision-making
• Ability to thrive in a fast-paced, entrepreneurial biotech environment