Director of Study Management

Job Details: Job Location: SLC

• Millcreek , UT, Position Type: Full Time, Salary Range: Undisclosed, Primary Purpose: This role is responsible for the successful delivery of bioanalytical studies supporting small molecule and biologic development from nonclinical through clinical phases. This role provides strategic leadership and oversight of the study management team, ensuring studies are executed on time, in compliance with regulatory requirements, and to the highest quality standards. Serving as a Principal Analytical Investigator, the incumbent is accountable for the scientific and regulatory integrity of assigned studies and provides expert guidance throughout study execution. The position acts as the primary liaison between sponsors and internal teams, fostering strong partnerships through proactive communication, risk management, and issue resolution. This role also leads team development, capacity planning, and cross-functional collaboration to ensure operational excellence, sponsor satisfaction, and successful study outcomes. Job Duties and Responsibilities: Lead, coach, and develop Principal Analytical Investigators (PAIs) and project coordinators, including performance management, succession planning, and talent development. Oversee study delivery across the portfolio, ensuring projects are executed on time, within scope, and in compliance with applicable regulatory and quality requirements. Partner with Laboratory Operations, Quality Assurance, and Finance to align resources, manage study capacity, budgets, utilization, and operational priorities. Serve as the primary escalation point for sponsors, providing scientific and operational leadership, resolving issues proactively, and maintaining strong client relationships. Support business growth through proposal development, capability presentations, and partnership 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 and support sponsor audits and regulatory inspections. Working Conditions: Office environment with occasional laboratory exposure. Essential physical requirements include going up/downstairs, typing, and sitting or standing for long periods. Physical effort requirements are moderate (ranging from sedentary to lifting boxes up to 10-15 pounds).

Qualifications

Experience: Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field with 11+ years of regulated bioanalytical experience; M.S. with 13+ years; or B.S. with 15+ years. Minimum 5 years of experience serving as a Principal Analytical Investigator (PAI), Study Director, or equivalent leadership role supporting GLP and/or GCP bioanalytical studies.

Minimum 5 years of people leadership experience managing scientific teams or managers, preferably within a contract research organization (CRO) environment. Demonstrated experience managing complex study portfolios, including timelines, budgets, resource allocation, and financial performance. Experience hosting sponsor audits and regulatory inspections.

Knowledge, Skills, and Abilities: 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 Part 58 and Part 11 requirements. Sound scientific and business judgment with the ability to balance quality, compliance, timelines, and financial considerations.

Proven 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 effectively. Strong operational and analytical skills with the ability to manage performance through metrics, identify risks, and drive successful outcomes.

Preferred Qualifications

Experience leading teams across multiple sites, regions, or organizational growth initiatives. Expertise supporting biologics, large-molecule pharmacokinetics (PK), anti-drug antibody (ADA), and biomarker assay programs. Experience with laboratory informatics systems (e.g., Watson LIMS), electronic laboratory systems, and KPI/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.