Senior Manager, GLP Nonclinical Studies (Biotech)

Scribe Therapeutics; Alameda (CA); On-site; USD 140,000 - 230,000; Full time

Benefits offered by this job

Health benefits

Equity

Wellness stipend

Job summary

Scribe Therapeutics is seeking a Senior Manager/Associate Director, Nonclinical Study Management to oversee outsourced GLP studies and ensure regulatory readiness. You will collaborate with internal scientists, CROs, and vendors to drive study execution and maintain high quality standards.

The role involves coordinating quotes, contracts, and reports, tracking deliverables, and enabling timely regulatory submissions. Travel up to 20% domestically and internationally is expected.

Qualifications

• Bachelor’s degree in biology/toxicology/biotechnology or related field.
• 8+ years of related work experience in drug development.
• Proficient knowledge of GLP guidelines for nonclinical studies.
• Experience managing IND enabling studies.
• Excellent verbal and written communication skills.
• Strong attention to detail in study-related documentation.

Responsibilities

• Oversee outsourcing of preclinical (GLP and non-GLP) studies for regulatory submissions.
• Liaise with CROs; manage quotes, contracts, and final reports.
• Provide CRO oversight to ensure consistent practices across sites.
• Monitor deliverables for regulatory compliance and scientific integrity.
• Communicate study updates with internal stakeholders and teams.
• Coordinate global shipment of test articles and samples between CROs.

Skills

Organization

Communication

Compliance

Quality

Problem solving

Education

Bachelor’s degree in biology/toxicology/biotechnology or related field

Job description

Scribe Therapeutics is seeking a Senior Manager/Associate Director, Nonclinical Study Management to oversee outsourced GLP studies and ensure regulatory readiness. You will collaborate with internal scientists, CROs, and vendors to drive study execution and maintain high quality standards.

The role involves coordinating quotes, contracts, and reports, tracking deliverables, and enabling timely regulatory submissions. Travel up to 20% domestically and internationally is expected.