ALLInBio, Inc. · 3 days ago
Head of Clinical Operations (Director+ Level) (Title flexible based on experience)
Palo Alto, CA
Full-time
Hybrid
Lead/Staff, Director/Executive
5+ years expALLInBio, Inc. is a clinical-stage biotechnology startup focused on developing innovative therapies for patients with serious unmet medical needs, particularly in autoimmune diseases. The role of Head of Clinical Operations involves leading the execution of global clinical trials while collaborating with various stakeholders to ensure compliance and operational efficiency.
Biotechnology
Hiring Manager
Charlotte B.
Responsibilities
Lead or support the planning, initiation, execution, and close-out of clinical trials (Phase I–III)
Manage day-to-day clinical operations activities while ensuring timelines, quality, and budget adherence
Develop and maintain key trial documents (e.g., protocols, ICFs, monitoring plans, TMF plans)
Select, manage, and oversee CROs and vendors (e.g., monitoring, data management, labs)
Review and approve monitoring reports, metrics, and deliverables
Serve as the primary operational point of contact for external partners
Ensure trials are conducted in compliance with ICH-GCP, FDA, MHRA, EMA, and local regulations
Support regulatory submissions and approvals in the US, UK, and EU (e.g., IND/CTA)
Oversee Trial Master File (TMF) completeness and inspection readiness
Support site selection, initiation, and ongoing site management
Collaborate with investigators and site staff to address enrollment, compliance, and quality issues
Identify and mitigate operational risks impacting site performance
Work closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Safety and Technical Operations
Provide operational input into protocol design, feasibility, and study budget and timelines
Contribute to process development and continuous improvement in a startup setting
Qualification
Required
Bachelor's degree in life sciences or related field (advanced degree preferred)
5+ years of hands-on clinical operations experience (flexible based on seniority)
Direct experience managing clinical trials in the US, UK, and EU
Strong knowledge of ICH-GCP and global clinical trial regulations
Demonstrated ability to work independently and manage multiple priorities
Experience working in a startup or small biotech environment
Preferred
Experience in autoimmune diseases, immunology, or inflammatory indications
Experience across multiple trial phases (Phase I–III)
Prior involvement in inspections or audits (FDA, EMA, MHRA)
Ability to build and improve clinical operations processes from the ground up
Benefits
Competitive compensation and benefits
Company
ALLInBio, Inc.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase