Senior Clinical Trial Lead Global Remote-Eligible

Expedition Therapeutics Inc.; San Francisco (CA); Remoto; USD 140.000 - 190.000; Tempo pieno

Descrizione del lavoro

Expedition Therapeutics Inc. is seeking a Clinical Operations leader to independently drive trials end-to-end in a small biotech setting.

You will manage cross-functional teams, CROs, and external partners to ensure trials run efficiently, compliantly, and aligned with program objectives. The role offers full-time, exempt status with ideal locations in San Diego or Boston; remote work is acceptable, with up to ~25% travel.

Competenze

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• At least 8 years of clinical research experience, including 3+ years as a Clinical Trial Manager; global trial management preferred.
• Experience leading global Phase I–III studies in respiratory, rare disease, or other specialty areas.
• Strong knowledge of ICH-GCP guidelines and applicable regulations.
• Strong leadership, written and verbal communication, analytical and problem-solving skills.
• Excellent interpersonal skills; able to work independently and collaboratively.
• Flexible, hands-on and able to manage multiple priorities in a startup environment.
• Demonstrated ability to manage CROs and external vendors.
• Ability to travel domestically and internationally up to ~25%.

Mansioni

• Independently lead clinical trials from start-up through close-out, including study team leadership, timeline and enrollment management, and close-out planning.
• Proactively identify and manage operational risks, issues, and dependencies, implementing mitigation and contingency plans to keep trials on track.
• Lead the selection and oversight of CROs, vendors, and external partners, including contract and clinical budget management, performance monitoring, and continuous improvement.
• Review and approve internal and vendor study plans and processes, as applicable.
• Ensure study master files are complete, accurate, and compliant with GCP requirements.
• Lead internal and external clinical study team meetings with CROs and service providers, representing Clinical Operations as appropriate.
• Ensure compliance with ICH-GCP, FDA, EMA, and applicable local regulatory requirements.
• Collaborate with Regulatory Affairs, Quality, and Pharmacovigilance on regulatory submissions, safety reporting, audits, and inspections.
• Partner with Clinical Development, Data Management, Biostatistics, Clinical Pharmacology, and Drug Supply teams.
• Mentor and guide junior Clinical Operations staff.
• Develop processes, SOPs, and best practices to support a growing biotechnology organization.

Conoscenze

Clinical operations leadership

Vendor management

Cross-functional collaboration

Regulatory knowledge

Problem solving

Communication

Travel readiness

Formazione

Bachelor’s degree in life sciences or related field

Descrizione del lavoro

Expedition Therapeutics Inc. is seeking a Clinical Operations leader to independently drive trials end-to-end in a small biotech setting.

You will manage cross-functional teams, CROs, and external partners to ensure trials run efficiently, compliantly, and aligned with program objectives. The role offers full-time, exempt status with ideal locations in San Diego or Boston; remote work is acceptable, with up to ~25% travel.