<p>Who we are looking for:</p> <p>Vor Bio is seeking a Vice President of Clinical Operations.</p> <p>Primary Responsibilities</p> <ul> <li>Define strategic direction for an integrated project team for all the indication / clinical development programs </li><li>Lead operational resource planning, implementation, and execution to support multiple global clinical trials </li><li>Develop, maintain, and report on program budgets, including forecasting in support of financial goals </li><li>Define and help manage the development of clinical study protocols, documents, procedures, study reports, charters, presentations, and publications </li><li>Manage clinical study leads / managers and clinical research associates </li><li>Create team study training, tools and metrics and monitor accordingly </li><li>Identify outsourcing model best suited for clinical development success </li><li>Identify vendors, perform capabilities assessments, and conduct formal request proposal process (RFP) including summary evaluation of key factors and bid defense </li><li>Act as point of contact for escalation management of external vendors and / or CROs </li><li>Prepare and present key study updates to senior management, and other key stakeholders </li><li>Involved in building relationships with trial site and KOLs to maximize scientific expertise, patient recruitment and data collection </li><li>Ensure advocacy and voice of the patient is represented in planning, design and conduct of clinical trials </li></ul> <p>Education and Experience</p> <ul> <li>Bachelor's or master's degree in scientific, biological, life sciences, or related field </li><li>At least 15 years of clinical trial management experience with at least 5 years in a leadership role with proven record of accomplishment of people and project management </li><li>In-depth knowledge of clinical operations and pharmaceutical drug development process in the autoimmune therapeutic area, or in rare diseases, preferred. </li><li>Technical expertise in and / or understanding of cross-function clinical trials processes from study start-up through study closure (e., data management, safety, biostatistics, medical writing) </li><li>Experience managing global studies </li><li>Working, in-depth knowledge of industry standards including ICH guidelines, GCPs and the CFR; familiarity with EMA / CHMP regulations and guidelines and other international regulatory requirements is a plus </li><li>Experience with NDAs, MAA, or other agency new drug application submissions </li><li>Track record of excellence in effective management of multiple projects / priorities and budgets, ranging from early to late stage development programs </li><li>Understanding of comprehensive global pharmaceutical regulatory requirements and strategic implications for clinical development operations </li><li>Demonstrated, effective project management skills </li><li>Ability to work independently, take a leadership role and drive quality progress </li><li>Ability to assess complex issues and identify creative, practical solutions </li><li>Ability to foster effective relationships with vendors, investigators, consultants and colleagues </li><li>Demonstrated ability to work independently as well as in a team environment </li><li>Excellent written, oral and presentation communication skills </li><li>Proficiency in Microsoft Project and / or other project management software and tools and Microsoft Office (Excel, Word, Outlook, PowerPoint) </li></ul>