Manager/Senior Manager Of Non-Clinical Operations

Overview

• Manage operational oversight of outsourced non-clinical studies at CROs for AAV-based gene therapy.
• Collaborate with internal teams and vendors to ensure study logistics and compliance with regulations.
• Coordinate bioanalysis and sample tracking throughout study phases and storage periods.
• Liaise with Medical Writing to manage authoring and review of regulatory documents.
• Summarize key data findings and scientific publications for internal review.
• Ensure adherence to Good Laboratory Practices (GLPs) and company SOPs.
• Monitor study timelines, deliverables, and budget, escalating issues as needed.
• Collaborate with stakeholders across Clinical, CMC, Regulatory Affairs, and Finance teams.

Key Responsibilities & Duties

• Lead work plans and SOWs with department leaders and CROs.
• Coordinate vendor meetings, document minutes, and follow up on action items.
• Monitor study plans, timelines, and progress against forecasted timelines and budgets.
• Ensure bioanalysis coordination and sample tracking throughout study phases.
• Work closely with Medical Writing to manage regulatory document authoring and review.
• Summarize data findings and scientific publications for internal presentations.
• Collaborate with quality assurance to ensure compliance checks are conducted.
• Engage with internal and external stakeholders to align study objectives.

Job Requirements

• Bachelor’s degree in life sciences, pharmacology, biology, or related fields.
• Minimum 10 years of experience in non-clinical operations or related roles.
• Experience with AAV gene therapy products and regulatory document authoring.
• Knowledge of GLP and ICH guidelines and study management practices.
• Strong initiative, accountability, and ability to work under tight deadlines.
• Excellent collaboration, communication, and multi-tasking skills.
• Ability to thrive in a fast-paced, dynamic environment.
• Results-oriented with a bias for action and problem-solving.