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About the Role
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.
Responsibilities
- 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.
- 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.
- 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.
- 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.
- 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.
Requirements
- 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.
- Experience supporting Phase 1 through Phase 3 clinical studies.
- Experience with pain, neuroscience, ion channel, or CNS drug development programs.
Skills
- Ligand binding assays
- LC-MS/MS methodologies
- Biomarker assay platforms
- Strategic thinking
- Scientific leadership
- Project management
- Organizational skills
- Written communication
- Verbal communication
- Collaboration
- Team-oriented mindset
- Sound judgment
- Decision-making
Location
- Thousand Oaks, CA
- San Francisco, CA
Work Type
- Full Time
Experience Level
- 8+ years of relevant industry experience
- 12+ years of relevant industry experience
- 15+ years of relevant industry experience
Education Level
- Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Molecular Biology, Pharmacology, or a related scientific discipline
- M.S. degree
- B.S. degree
About the Company
- Latigo Biotherapeutics, Inc. is an early-stage biotechnology company focused on discovering and developing the next generation of non-opioid medicines for pain and pain-related syndromes.
- Our mission is the development of novel therapies that transform the lives of patients.
- The company is headquartered in Thousand Oaks, CA and has a highly successful management team and an experienced Board of Directors.
- At Latigo, we value science, patient-focus, and innovation.