Sr. Clinical Trial Manager

Expedition Therapeutics Inc. is an innovative, science-driven biotechnology company focused on developing novel therapeutics for chronic and acute respiratory diseases, including Chronic Obstructive Pulmonary Disease (COPD), Bronchiectasis, and Asthma. Our team combines deep discovery and development expertise with a nimble, collaborative culture to advance differentiated programs from early research through late-stage clinical development and commercialization.

Position Summary

You are a clinical operations professional who is excited to “roll up your sleeves” and understands how trials are executed end-to-end in a small biotech setting. The successful candidate will bring hands-on clinical operations experience, sound judgment, and the ability to lead cross-functional teams, solve problems proactively, and communicate clearly in a fast-paced environment. The individual in this role will lead cross-functional teams and manage CROs and external vendors to ensure studies are conducted efficiently, compliantly, and in alignment with program objectives. This is a full-time, exempt position with ideal location in San Diego, CA or Boston, MA. Candidate needs to be comfortable with working remotely.

Key Responsibilities

• 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.

Qualifications & Experience

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