Director of Study Management

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).