Alterome Therapeutics, Inc

Clinical Operations

• Oversee/monitor Clinical Trial progress including, but not limited to, drug safety, assessments and tracking of patient safety and protocol deviations.
• Safe and timely execution of Clinical Trial from sponsor role.
• Vendor (e.g., CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) oversight for adherence to budget, timelines, and organizational objectives of individual protocols/programs.
• Ensure all Vendor contracts/legal documents current and on file at Alterome.
• Metrics management as identified by Head of Clinical Operations.
• Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial.
• Obtains and maintains in-depth understanding of the study protocol and related procedures to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure.
• Perform periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.
• Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
• Meets with vendors to ensure proper vendor oversight.
• Supports financial management of the study which may include review and approval of site and vendor invoices.
• Supports Risk Management initiatives.
• Proactively alert cross functional team to any risks identified and note suggested risk mitigation to identified risks.
• Supports the filing of legal, team documents in SharePoint working Cross Functionally with Project Management, Clinical, Regulatory and Medical team members.
• Maintain clinical trial registry entry/updates, as required.
• Drives site start-up, subject enrollment, clinical monitoring activities, clinical site compliance and data metrics from CROs, central labs, and other external vendors.
• Maintain direct contact and relationships with clinical sites participating in Alterome clinical studies to ensure high-quality and efficient execution of ongoing and planned clinical trial operations.
• Leads development and execution of operational activities outlined in various study plans, SOPs, study procedures, etc.
• Performs administrative functions and additional duties as assigned. Various activities in support of Clinical, Project Management, Regulatory and Medical team members.

Director, Clinical Operations

Medical Director

• Contribute to the design and implementation of clinical development plans, protocols, and study designs in alignment with corporate goals and regulatory expectations.
• Draft and review study-related documents including protocols, investigator brochures, IND amendments, and clinical sections of regulatory submissions.
• Support the VP, Clinical Development in preparing presentations for executive leadership, board meetings, and scientific/medical forums.
• Act as sponsor lead for Phase I–II trial(s), ensuring compliance with protocol, GCP, and regulatory standards.
• Provide day-to-day oversight of study conduct and collaborate with internal cross-functional teams, CROs and other external vendors (eg, clinical operations, regulatory, data management, biostatistics, pharmacovigilance, medical writing).
• Partner with pharmacovigilance providers to ensure accurate, timely safety reporting.
• Collaborate with Clinical Development Scientist team to ensure timely review of data listings, safety reports, and interim analyses to support timely, data-driven decisions.
• Monitor trial progress and timelines proactively to identify and mitigate risks.
• Participate in safety monitoring activities, including clinical review of adverse events, dose-escalation discussions, and safety data reconciliation.
• Provide medical/scientific guidance to investigators and clinical sites.
• Engage with key opinion leaders (KOLs) and investigators to inform study design and program advancement.
• Contribute medical and scientific expertise to publications, abstracts, and presentations.

Director, Clinical Operations

Medical Director, Clinical Development