Sr Dir or VP of Clin Ops

Company: ALLInBio, Inc.
Location: Stanford
Posted on: February 15, 2026

Job Description:

Location Headquarters in Palo Alto, CA, USA. Company Overview We are a clinical-stage biotechnology startup focused on developing innovative therapies for patients with serious unmet medical needs, with a primary focus on autoimmune diseases. We operate in a fast-paced, highly collaborative environment and value entrepreneurial individuals who thrive in building processes, solving problems, and executing clinical trials hands-on. We operate in a “virtual but local” manner. This implies that the candidate can work from any place of their choice but must be available to meet in person on a weekly basis at our headquarters in Palo Alto, CA, USA. Role Summary We are seeking a Clinical Operations professional with hands-on experience conducting global clinical trials across the United States, United Kingdom, and European Union. This role will be responsible for the end-to-end execution of clinical studies, working closely with CROs, investigators, vendors, and internal cross-functional teams. Prior experience in autoimmune or immunology indications is strongly preferred but not required. This role is ideal for someone who enjoys wearing multiple hats and contributing directly to trial execution in a startup environment. Key Responsibilities Clinical Trial Execution 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) Vendor & CRO Management 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 Global Regulatory & Compliance 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 Site Management 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 Cross-Functional Collaboration 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 Required Qualifications 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 Qualifications 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 Key Competencies Hands-on, execution-focused mindset Strong organizational and project management skills Excellent communication and presentation skills and stakeholder management abilities Proactive problem-solver comfortable with ambiguity Team-oriented with a strong sense of ownership Why Join Us Opportunity to make a direct impact on clinical programs and patients High visibility and responsibility in a growing startup Collaborative, science-driven culture Competitive compensation and benefits

Keywords: ALLInBio, Inc., Stockton , Sr Dir or VP of Clin Ops, Science, Research & Development , Stanford, California