Senior Clinical Trial Lead — Autoimmune Biotech

Precision Point; San Francisco (CA); Sur place; USD 180 000 - 210 000; Plein temps

Résumé du poste

Precision Point, a SF Bay Area biotech, seeks a Study Operations Leader to drive Phase 1–3 trials in autoimmune and inflammatory diseases. You will manage timelines, budgets, and regulatory compliance to ensure on-time deliveries across complex programs.

Responsibilities include CRO/vendor oversight, site activation and enrollment, TMF/eTMF readiness, and cross-functional collaboration. Mentorship of CTMs and the broader clinical operations team is expected.

Qualifications

• Bachelor's degree in life sciences, nursing, or a related field.
• 5–7 years clinical operations experience in biotech or pharmaceutical industry, including at least 3 years managing clinical trials as a CTM or equivalent.
• Direct hands-on experience managing clinical trials in autoimmune or inflammatory disease.
• Sponsor-side (in-house) experience, with demonstrated CRO and vendor oversight.
• Experience across the full study lifecycle, from startup and site activation through closeout and database lock.
• Strong working knowledge of ICH GCP, FDA regulations, and global clinical trial requirements.
• Proven ability to manage study budgets, timelines, and vendor contracts.
• Excellent communication, organization, and problem solving skills, with the ability to influence without authority.

Responsabilités

• Lead the operational planning and execution of Phase 1 through Phase 3 trials in autoimmune/inflammatory indications.
• Serve as primary operational contact for assigned studies, driving timelines and deliverables.
• Develop and maintain study plans including monitoring, recruitment, retention, and risk management.
• Contribute to protocol development, informed consent forms, CRF design, and other key documents.
• Select, manage, and hold CROs and specialty vendors accountable.
• Review vendor scopes of work, budgets, invoices, and change orders.
• Conduct regular performance reviews against KPIs and elevate issues proactively.
• Partner with sites and KOLs to drive startup, activation, and enrollment.
• Develop creative recruitment strategies for autoimmune populations.
• Oversee site monitoring activities and ensure timely issue resolution.
• Maintain inspection readiness through oversight of TMF/eTMF.
• Collaborate on data review, query resolution, and database lock.
• Support audits and regulatory inspections, and drive CAPA plans.
• Lead or co-lead the Study Execution Team and present study status to leadership.
• Support clinical study reports, regulatory submissions, and investigator meetings.
• Mentor CTMs, CTAs, and CRAs; oversee multiple studies or a program.

Connaissances

Clinical Operations

Vendor Oversight

Regulatory Knowledge

Budget Management

Project Leadership

Formation

Bachelor's degree in life sciences

Outils

CTMS

eTMF

EDC

IRT systems

Description du poste

Precision Point, a SF Bay Area biotech, seeks a Study Operations Leader to drive Phase 1–3 trials in autoimmune and inflammatory diseases. You will manage timelines, budgets, and regulatory compliance to ensure on-time deliveries across complex programs.

Responsibilities include CRO/vendor oversight, site activation and enrollment, TMF/eTMF readiness, and cross-functional collaboration. Mentorship of CTMs and the broader clinical operations team is expected.