Study Director, Study Director, In Vivo Pharmacology (San Diego)

Position Summary

We are seeking a Study Director to manage and execute in vivo preclinical studies from initiation through final reporting. This role serves as the single point of responsibility for study management and control following project award. The Study Director will work closely with internal leadership to align on study design and ensure high-quality execution, effective team coordination, and consistent client communication throughout the study lifecycle. This is an ideal opportunity for a hands-on Study Director who is strong in execution, detail-oriented, and comfortable managing multiple studies in a structured team environment.

Key Responsibilities

Study Management and Execution

• Take ownership of studies upon contract execution and ensure timely, high-quality delivery

• Support and refine study design in collaboration with senior leadership

• Develop study protocols, schedules, and execution plans aligned with client requirements

• Maintain overall responsibility for the technical conduct of studies, including protocol execution and amendments

Team Coordination

• Lead pre-study (kick-off) meetings and align internal In Vivo teams

• Delegate responsibilities to Research Associates and technical staff

• Monitor day-to-day study progress and ensure adherence to protocols and SOPs

Client Communication

• Serve as the primary point of contact for day-to-day client communication

• Provide regular updates on study progress, timelines, and key milestones

• Escalate risks, changes, or critical decisions to senior leadership as appropriate

Data Review and Reporting

• Review study data throughout all phases to ensure accuracy, completeness, and consistency

• Support data analysis and interpretation

• Prepare and finalize comprehensive study reports in accordance with regulatory and client requirements

Compliance and Quality

• Ensure studies are conducted in compliance with GLP regulations (21 CFR Part 58) and internal SOPs

• Identify, document, and manage study deviations, protocol changes, and corrective actions (CAPA)

• Maintain complete, accurate, and audit-ready study documentation

• Collaborate with QA to support audits and inspections

Study Oversight and Coordination

• Manage multiple concurrent studies as the primary study coordinator

• Coordinate with internal teams, veterinarians, and QA to ensure smooth study execution

• Oversee external vendors or subcontracted activities as needed

Qualifications Required

• Bachelor’s or Master’s degree in Biology, Pharmacology, or related field (PhD is a plus, not required)

• 6–9 years of experience in in vivo research, including: o 1–3 years in a Study Director or study lead role

• Experience executing preclinical studies in a CRO or regulated environment

• Strong understanding of GLP regulations (FDA 21 CFR Part 58)

• Hands-on experience with in vivo techniques (dosing, sample collection, etc.)

• Proven ability to manage multiple studies with guidance from leadership

• Strong organizational, documentation, and communication skills

Preferred

• CRO experience with client-facing exposure

• Familiarity with IACUC and animal research compliance

• Experience mentoring junior staff or overseeing small teams

What We’re Looking For

• Strong executor who can run studies reliably and independently

• Detail-oriented with a focus on quality, compliance, and timelines

• Comfortable working in a structured, team-oriented environment

• Good judgment in knowing when to act independently vs. escalate