Director of Study Management

ALIRI • Millcreek, UT

4d • Onsite

About The Position

The Director of Study Management is responsible for successfully delivering bioanalytical studies supporting small-molecule and biologic development from nonclinical through clinical phases. The role provides strategic leadership and oversight of the study management team, ensuring studies are delivered on time, in compliance with regulatory requirements, and to high quality standards. Serving as a Principal Analytical Investigator, the Director is accountable for the scientific and regulatory integrity of assigned studies and provides expert guidance throughout study execution.

The position is the primary liaison between sponsors and internal teams, building strong partnerships through proactive communication, risk management, and issue resolution. It also leads team development, capacity planning, and cross-functional collaboration to support operational excellence, sponsor satisfaction, and successful study outcomes.

Requirements

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field and 11 or more years of regulated bioanalytical experience; or an M.S. and 13 or more years; or a B.S. and 15 or more years.
• At least 5 years of experience serving as a Principal Analytical Investigator, Study Director, or equivalent leader supporting GLP and/or GCP bioanalytical studies.
• At least 5 years of people leadership experience managing scientific teams or managers, preferably in a contract research organization environment.
• Demonstrated experience managing complex study portfolios, including timelines, budgets, resource allocation, and financial performance.
• Experience hosting sponsor audits and regulatory inspections.
• Strong scientific expertise in LC-MS/MS and ligand-binding assays, method validation, and regulated sample analysis.
• Comprehensive knowledge of bioanalytical regulations and guidance, including ICH M10, FDA and EMA bioanalytical guidance, and 21 CFR Parts 58 and 11.
• Sound scientific and business judgment, with the ability to balance quality, compliance, timelines, and financial considerations.
• Ability to influence and collaborate across cross-functional teams, including Quality Assurance, Laboratory Operations, Finance, and Business Development.
• Excellent sponsor-facing, executive communication, and relationship management skills, including the ability to navigate challenging situations.
• Strong operational and analytical skills, including managing performance through metrics, identifying risks, and driving successful outcomes.

Nice To Haves

• Experience leading teams across multiple sites or regions, or supporting organizational growth initiatives.
• Expertise supporting biologics, large-molecule pharmacokinetics (PK), anti-drug antibody (ADA), and biomarker assay programs.
• Experience with laboratory informatics systems such as Watson LIMS, electronic laboratory systems, and KPI or dashboard reporting tools.
• Training or certification in Lean, Six Sigma, or other continuous improvement methodologies.
• Experience partnering with Business Development on proposal preparation, project scoping, and client solution development.
• Demonstrated success recruiting, retaining, and developing high-performing bioanalytical talent.

Responsibilities

• Lead, coach, and develop Principal Analytical Investigators and project coordinators, including performance management, succession planning, and talent development.
• Oversee study delivery across the portfolio, ensuring projects are completed on time, within scope, and in compliance with applicable regulatory and quality requirements.
• Partner with Laboratory Operations, Quality Assurance, and Finance to align resources and manage study capacity, budgets, utilization, and operational priorities.
• Serve as the primary escalation point for sponsors, providing scientific and operational leadership, proactively resolving issues, and maintaining client relationships.
• Support business growth through proposal development and capability presentations, partnering with Business Development to ensure achievable project commitments.
• Drive operational excellence through process standardization, continuous improvement initiatives, KPI monitoring, deviation investigations, CAPA oversight, and inspection readiness.
• Report portfolio performance, risks, and resource needs to executive leadership.
• Support sponsor audits and regulatory inspections.

What This Job Offers

• Job Type: Full-time
• Career Level: Director