<p>Who we are looking for:</p> <p>Vor Biopharma is seeking an Director/Associate Director of Clinical Operations to manage assigned autoimmune programs. The ideal candidate will initiate and lead clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. The successful candidate will report to the Head of Clinical Operations. The Director/Associate Director will also work collaboratively across the therapeutic area and cross-functional teams on the overall development programs and related studies to ensure the successful execution of assigned projects.</p> <p>Experience and knowledge of end-to-end management of clinical trial operations, knowledge of the pharmaceutical industry, and an understanding of clinical drug development and clinical trials operations are essential.</p> <p>Key areas of responsibilities:</p> <ul> <li>Accountable for delivery of assigned clinical program/studies budget, timelines, and resource management with a focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives </li><li>Ensure clinical trials comply with ICH/GCP guidelines, regulations, and company SOPs </li><li>Develop operational strategy and clinical operations plans to support the execution of the Clinical Development Plan </li><li>Support the selection, oversight, and management of CROs and other vendors </li><li>Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team </li><li>Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports, and other documents and plans as appropriate </li><li>Manage the cross-functional team and CRO/vendor(s) related to all aspects of clinical trial operations </li><li>Assist in forecasting clinical trial material and ancillary supplies </li><li>Represent Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensure compliance with operational standards and procedures </li><li>Ensure timely review of protocol deviations and assess the impact on study data </li><li>Along with other Clinical Development personnel, represent Vor Biopharma externally to Investigators, site staff, and Key Opinion Leaders </li><li>Perform and document study level Sponsor Oversight of outsourced clinical activities </li><li>Communicate study status, cost, and issues to ensure timely decision-making by senior management </li><li>Oversee/collaborate and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct </li><li>Develop and foster strong, collaborative relationships with key stakeholders both within and external to Vor Biopharma </li><li>Support program level deliverables/activities at the discretion of the Head of Clinical Operations </li><li>Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise </li><li>Oversee or conduct routine completeness checks of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs and ensure all appropriate documents are filed </li><li>Participate and respond to Quality Assurance and/or regulatory authority inspection audits </li><li>Facilitate the development of trial budgets and execution of clinical trial agreements and other relevant documents in conjunction with CRO and appropriate internal stakeholders </li><li>Manage the clinical trial budget and provide financial reporting and projections to Finance </li><li>Lead creation of scope of work and budgets and escalate vendor performance issues to Head of Clinical Operations and Outsourcing as necessary </li></ul> <p>Qualifications:</p> <ul> <li>BA or BS in a scientific, life science, or health-related discipline; advanced degree preferred </li><li>Minimum of 8 years of experience in clinical research with at least 5 years of managing trials in the biotech/pharma industry and/or prior CRO experience </li><li>Experience in setup, execution, and oversight/operational management of autoimmune or relevant trial experience </li><li>Experience working on late stage studies (Phase II, III) </li><li>Excellent communication, writing, and presentation skills with strong problem-solving ability and attention to detail </li><li>Strong initiative and a can-do attitude, excellent organizational skills, ability to prioritize deliverables/tasks to meet deadlines, and proven effectiveness in a fast-moving and growing biotech environment </li><li>Solid working knowledge of ICH/GCP guidelines and the application to the conduct of clinical trials </li><li>Proficient in MS Office Suite and understanding of Clinical Trial Management System, eTMF, and EDC systems, as required </li><li>Ability/willingness to travel as required </li><li>Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry </li></ul>