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Vice President Bioanalytics Jobs in California (NOW HIRING)

Gator Bio is a growth-stage bioanalytical company with a strong team and amazing products. We are executing the plan to build a leading brand in the life science tool business. Our first product line ...

Gator Bio is a growth-stage bioanalytical company with a strong team and amazing products. We are executing the plan to build a leading brand in the life science tool business. Our first product line ...

Gator Bio is a growth-stage bioanalytical company with a strong team and amazing products. We are executing the plan to build a leading brand in the life science tool business. Our first product line ...

VP of Global Sales

Palo Alto, CA ยท On-site

$250 - $280/hr

Gator Bio is a growthโ€‘stage bioanalytical company with a strong team and amazing products. We are executing the plan to build a leading brand in the life science tool business. Our first product ...

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Vice President Bioanalytics information

What does a vice president of bioanalytics do?

A Vice President of Bioanalytics leads and manages the bioanalytical strategy and operations within a pharmaceutical, biotechnology, or life sciences organization. This executive is responsible for overseeing teams that design, implement, and interpret bioanalytical studies to support drug discovery and development. They ensure regulatory compliance, collaborate with cross-functional leaders, and drive innovations in analytical technologies. Their role is crucial in ensuring that data about drug safety, efficacy, and metabolism is accurate and reliable, supporting regulatory submissions and product development goals.

What are the main challenges a vice president of bioanalytics might face when overseeing multiple projects across different therapeutic areas?

A Vice President of Bioanalytics often manages teams working on various projects, each with unique scientific and regulatory requirements. Balancing resources, maintaining data quality, and ensuring timelines are met can be challenging, especially when projects span different therapeutic areas with distinct analytical needs. Effective communication and collaboration with cross-functional teams such as clinical development, regulatory affairs, and external partners are essential to address these complexities. Staying current with advancements in bioanalytical technologies and evolving regulatory guidelines is also crucial for success in this leadership role.

What are the key skills and qualifications needed to thrive as a vice president of bioanalytics, and why are they important?

To thrive as a Vice President of Bioanalytics, you need deep expertise in bioanalytical methods, regulatory compliance, and a strong scientific background, typically with an advanced degree (PhD or MS) in life sciences. Familiarity with laboratory information management systems (LIMS), mass spectrometry, and regulatory guidelines such as GLP or GCP is essential. Exceptional leadership, strategic thinking, and effective communication skills help drive team performance and cross-departmental collaboration. These skills are vital for ensuring high-quality data, regulatory adherence, and successful execution of bioanalytical strategies in complex pharmaceutical or biotech environments.

What is the difference between Vice President Bioanalytics vs Director Bioanalytics?

AspectVice President BioanalyticsDirector Bioanalytics
Required CredentialsAdvanced degree (PhD/Master's), extensive industry experienceMaster's or PhD, significant industry experience
Work EnvironmentExecutive leadership, strategic planningOperational management, project oversight
Employer & Industry UsageBiotech, pharma companies, research organizationsBiotech, pharma, contract research organizations

The Vice President Bioanalytics typically holds a higher leadership role focused on strategic direction and executive decision-making, while the Director Bioanalytics manages day-to-day operations and project teams. Both roles require advanced degrees and industry experience, but the VP is more involved in long-term planning and organizational growth.

What are popular job titles related to Vice President Bioanalytics jobs in California?

For Vice President Bioanalytics jobs in California, the most frequently searched job titles are:

Vice President, Early Clinical Development

IMMUNEERING CORPORATION

San Diego, CA โ€ข On-site

$348K - $400K/yr

Full-time

Posted 3 days ago

New


Job description

ABOUT IMMUNEERING

Immuneering Corporation (Nasdaq: IMRX) is a clinical-stage biopharmaceutical company developing oncology therapies using its proprietary Deep Cyclic Inhibition platform. Our lead asset, atebimetinib (IMM-1-104), is an oral, once-daily Deep Cyclic Inhibitor of MEK in active Phase 2 and Phase 3 (MAPKeeper 301) clinical trials in pancreatic cancer and RAS-mutant non-small cell lung cancer, as well as additional solid tumor programs. We are committed to delivering transformative treatments to patients with limited options through rigorous science and a collaborative, mission-driven culture.


General Summary of Duties:

The Vice President will lead company-wide translational medicine, clinical biomarker, bioanalytical, and companion diagnostic strategy across the portfolio. This role will integrate mechanistic biology, PK/PD, immunogenicity, and fit-for-purpose assay development to support dose selection, patient stratification, regulatory interactions, and data-driven advancement from IND-enabling studies through clinical development.

Specific Duties, may include but not be limited to the following:

• Develop and execute integrated translational medicine, clinical biomarker, and bioanalytical strategies for oncology and other priority programs from discovery through Phase 0-3 development.

• Define proof-of-mechanism, pharmacodynamic, patient-selection, immunogenicity, and exploratory biomarker plans aligned with clinical development objectives.

• Partner with DMPK, Clinical Pharmacology, Toxicology, Discovery, Clinical Development, Regulatory Affairs, Biostatistics, and Medical Affairs to integrate PK/PD and biomarker data into dose and development decisions.

• Lead development, qualification, validation, transfer, and implementation of fit-for-purpose assays under GLP, GCLP, CLIA, and CAP expectations, as appropriate.

• Establish companion diagnostic and precision medicine strategies, including external IVD partnerships and regulatory planning.

• Author and review biomarker and bioanalytical sections of INDs, protocols, briefing documents, amendments, and clinical study reports; support FDA and EMA interactions.

• Provide strategic oversight of CROs, central laboratories, diagnostic partners, biospecimen operations, budgets, contracts, quality, and timelines.

• Lead translational governance and provide clear recommendations for dose optimization, patient stratification, and portfolio Go/No-Go decisions.

• Build, mentor, and manage a high-performing translational and bioanalytical team and represent Immuneering at scientific meetings and external collaborations.

Desired Skills and Qualifications

• Executive-level experience leading translational medicine, clinical biomarkers, bioanalytical sciences, and cross-functional drug-development teams.

• Deep expertise integrating ADME/DMPK, PK/PD, immunogenicity, biomarker, and clinical pharmacology strategies.

• Demonstrated experience in oncology, immunology, biologics, and/or advanced therapies, including cell and gene therapy.

• Exceptional written and verbal communication, strategic judgment, scientific curiosity, and collaborative leadership.

Education

• PhD, MD, PharmD, or equivalent advanced degree in immunology, pharmacology, oncology, molecular biology, biomedical sciences, or a related discipline.

• Typically 15+ years of relevant biotechnology or pharmaceutical experience, including significant leadership responsibility. Will consider people with the appropriate combination of education and years of experience holistically.

Technical / Soft Skills

• Proven record building translational biomarker frameworks for first-in-human (Ph0-1) and later-stage studies, including proof-of-mechanism, pharmacodynamic, immune-monitoring, and patient-selection endpoints.

• Experience with flow cytometry, multiplex platforms, cell-based assays, multi-omics, regulated bioanalysis, and biospecimen strategy.

• Strong knowledge of companion diagnostics, precision medicine, assay validation, and external diagnostic partnerships.

• Experience contributing to IND-enabling packages, pre-IND, INTERACT, Type C, and other health-authority interactions.

• Demonstrated ability to manage CROs and vendors, negotiate scopes and contracts, maintain quality oversight, and deliver against timelines and budgets.

• Ability to manage multiple workflows, make sound decisions in a fast-paced environment, and effectively influence cross-disciplinary teams.

• Self-starter who is motivated, ambitious, scientifically rigorous, collaborative, and committed to developing people and teams.

EQUAL OPPORTUNITY EMPLOYER

Immuneering Corporation is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.