5AM Ventures

• Responsible for the clinical operation function at the company and for representing clinical operations in cross-functional program teams, working closely with team leaders and other functional area subject matter experts • Accountable for the strategic planning and operational execution of clinical trials, ensuring they are conducted within agreed upon timelines, budgets, and regulatory quality standards. • Actively lead and/or participate in the development of clinical documents, including but not limited to protocols, ICFs, study manuals, investigator brochures, and clinical study reports. • Responsible for maintaining constructive interactions with clinical sites to ensure that all trials and programs have clearly defined plans, strategies, and milestones. • Actively lead the selection, management, and performance of study-related CROs, vendors, and external consultants. • Accountable for the management of clinical budgets. • Develop and maintain strong collaboration and communication with internal and external stakeholders, including regular communication of study-related metrics / KPIs to executive management and cross-functional study teams. • Promote a strong quality culture within Clinical Operations, ensuring clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/policies, and industry best practices. Participates and/or leads continuous improvement initiatives and collaborates in the development of Clinical Operations Standard Operating Procedures (SOP), Work Instructions (WI), training, and other tools to ensure compliance with FDA Regulations. • Lead responses to any audits as required (site, internal file, process, and regulatory agencies). • Develop and execute resourcing plans to ensure adequate and appropriate monitoring of all trials, including the evaluation and implementation of clinical technologies (e.g., EDC, eTMF, CTMS) appropriate for the company’s stage of growth. • Collaborate closely with CMC and Supply Chain teams to ensure clinical trial material (CTM) availability, stability, and proper handling/administration at clinical sites. • Provide accurate, current updates to executive management and program teams regarding the status of clinical trials.