Job Description

Director of Bioanalytical Study Management

Location: Millcreek, UT (Optional Work From Home)

Compensation: $150,000–$180,000 annually, depending on experience

About the Opportunity

Lighthouse Lab Services is partnering with a growing bioanalytical contract research organization (CRO) to identify an experienced Director of Bioanalytical Study Management. This individual will provide strategic, scientific, and operational leadership for bioanalytical studies supporting pharmaceutical and biotechnology development from nonclinical through clinical phases.

The Director will oversee a team of Principal Analytical Investigators (PAIs) and project coordinators, ensuring studies are delivered on time, within budget, and in accordance with applicable regulatory and quality standards. This role will serve as a key liaison between sponsors and internal departments, providing scientific oversight, managing client relationships, and driving operational performance across the study portfolio.

The ideal candidate will bring extensive experience in regulated bioanalysis, a strong background in GLP and/or GCP study management, and a demonstrated ability to lead scientific teams within a contract research or pharmaceutical environment.

Key Responsibilities

• Lead, mentor, and develop a team of Principal Analytical Investigators and project coordinators, including performance management, succession planning, and professional development.
• Oversee the execution and delivery of bioanalytical studies across the project portfolio, ensuring adherence to timelines, budgets, client expectations, and regulatory requirements.
• Partner with Laboratory Operations, Quality Assurance, and Finance to coordinate staffing, resource allocation, study capacity, budgets, and operational priorities.
• Serve as the primary escalation point for sponsors, providing scientific and operational guidance, resolving study-related issues, and maintaining strong client relationships.
• Support business development initiatives through proposal development, client presentations, technical discussions, and project feasibility assessments.
• Drive operational improvements through process standardization, performance metrics, KPI monitoring, deviation investigations, and corrective and preventive action (CAPA) initiatives.
• Monitor portfolio performance, identify operational risks, and communicate resource needs and business priorities to executive leadership.
• Support sponsor audits, regulatory inspections, and ongoing compliance initiatives.
• Foster collaboration across scientific, operational, and commercial teams to improve study execution, client satisfaction, and overall business performance.

Qualifications

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline with 11+ years of relevant experience; M.S. with 13+ years; or B.S. with 15+ years.
• Minimum of 5 years of experience serving as a Principal Analytical Investigator (PAI), Study Director, or in an equivalent leadership role supporting regulated bioanalytical studies.
• Minimum of 5 years of people management experience leading scientific teams, preferably within a contract research organization (CRO), pharmaceutical, or biotechnology environment.
• Demonstrated experience overseeing complex study portfolios, including project timelines, budgets, resource allocation, and financial performance.
• Experience supporting sponsor audits and regulatory inspections.
• Strong technical understanding of bioanalytical methods, including LC-MS/MS, ligand-binding assays, method validation, and regulated sample analysis.
• Comprehensive knowledge of applicable regulatory guidance, including ICH M10, FDA and EMA bioanalytical guidance, 21 CFR Part 58, and 21 CFR Part 11.
• Excellent leadership, organizational, communication, and client relationship management skills.
• Ability to balance scientific quality, regulatory compliance, operational efficiency, and financial objectives.
• Demonstrated ability to collaborate across Quality Assurance, Laboratory Operations, Finance, and Business Development.

Preferred Qualifications

• Experience leading teams across multiple sites, regions, or periods of organizational growth.
• Expertise supporting biologics, large-molecule pharmacokinetics (PK), anti-drug antibody (ADA), and biomarker assay programs.
• Familiarity with laboratory information management systems (LIMS), particularly Watson LIMS, electronic laboratory systems, and KPI reporting tools.
• Training or certification in Lean, Six Sigma, or other continuous improvement methodologies.
• Experience partnering with Business Development on proposals, project scoping, and client solutions.
• Demonstrated success recruiting, retaining, and developing high-performing scientific teams.

Work Environment

• Based in Millcreek, UT, with optional work-from-home flexibility.
• Primarily office-based with occasional exposure to laboratory environments.
• Must be able to sit or stand for extended periods and perform routine computer-based work.
• Occasional physical activity, including navigating stairs and lifting boxes weighing approximately 10–15 pounds.

Compensation & Benefits

• Estimated annual salary range of $150,000–$180,000, depending on experience and qualifications.
• Additional benefits and employment details to be discussed during the interview process.

Apply today to learn more about this opportunity.

About us:

At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 22 years of proven success placing job seekers in positions ranging from entry-level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.

It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. Lighthouse Lab Services is committed to working and providing reasonable accommodation to individuals of all abilities, including persons with disabilities.

If at any time during the application process, you need accommodation, please contact recruiting@lighthouselabservices.com for assistance.

Lighthouse Lab Services | 844-974-1929 | lighthouselabservices.com

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