Senior Clinical Trial Manager (Biotech)

TL;DR

Senior Clinical Trial Manager (Biotech): Leading the startup, execution, and closeout of late-stage clinical trials for COPD programs with an accent on vendor management, budget oversight, and regulatory compliance. Focus on managing CROs, ensuring GCP adherence, and coordinating cross-functional study teams to accelerate drug development.

Location: Remote (Must be based in the USA); ability to travel up to 30% domestic and international

Salary: $140,000 – $196,000 USD

Company

A clinical-stage generative biology company pioneering the AI revolution in drug design and development to create protein-based medicines.

What you will do

• Independently manage operational aspects of clinical trials, including CROs, central labs, and specialty laboratories.
• Lead cross-functional internal study teams and manage key relationships with trial sites and investigators.
• Supervise day-to-day trial execution, focusing on site start-up, patient enrollment, and data flow metrics.
• Develop and review critical study documents, including informed consent forms, operations manuals, and training materials.
• Manage clinical study budgets and execution timelines to ensure program goals are met.
• Collaborate with QA to ensure inspection readiness, TMF completeness, and compliance with GCP and regulatory requirements.

Requirements

• Bachelor’s degree required (Advanced scientific degree preferred).
• 8+ years of experience in clinical operations, with 4+ years in late-stage trial operations at a sponsor company.
• Proven experience in CRO, vendor, and laboratory oversight.
• Detailed knowledge of GCP; familiarity with FDA, EMA, and MHRA requirements is a plus.
• Ability to travel up to 30% of the time, both domestic and international.

Nice to have

• Experience in Respiratory indications (specifically Asthma/COPD).

Culture & Benefits

• Competitive base salary with annual bonus and equity compensation.
• Comprehensive benefits package.
• Opportunity to work at the intersection of machine learning and large-scale biological experimentation.
• Inclusive environment committed to equal employment opportunity.