Vor Bio
Vice President, Clinical Operations
Vor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. Our goal is to bring life-changing therapies to patients worldwide who are living with serious autoantibody-driven conditions. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology. We are advancing Telitacicept, a novel, dual-target recombinant fusion protein that inhibits both BLyS (BAFF) and APRILtwo key cytokines involved in B cell survival and autoantibody production. In a Phase 3 clinical trial in generalized myasthenia gravis in China, Telitacicept demonstrated a 4.8-point improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living scale) vs. placebo at 24 weeks, the primary endpoint of the trial. Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). A global Phase 3 clinical trial in gMG is currently underway across the United States, Europe, and South America to support potential approval in the United States and Europe. Who We Are Looking For:
Vor Bio is seeking a Vice President of Clinical Operations. Primary Responsibilities
Define strategic direction for an integrated project team for all the indication / clinical development programs Lead operational resource planning, implementation, and execution to support multiple global clinical trials Develop, maintain, and report on program budgets, including forecasting in support of financial goals Define and help manage the development of clinical study protocols, documents, procedures, study reports, charters, presentations, and publications Manage clinical study leads / managers and clinical research associates Create team study training, tools and metrics and monitor accordingly Identify outsourcing model best suited for clinical development success Identify vendors, perform capabilities assessments, and conduct formal request proposal process (RFP) including summary evaluation of key factors and bid defense Act as point of contact for escalation management of external vendors and / or CROs Prepare and present key study updates to senior management, and other key stakeholders Involved in building relationships with trial site and KOLs to maximize scientific expertise, patient recruitment and data collection Ensure advocacy and voice of the patient is represented in planning, design and conduct of clinical trials Education and Experience
Bachelor's or master's degree in scientific, biological, life sciences, or related field 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 In-depth knowledge of clinical operations and pharmaceutical drug development process in the autoimmune therapeutic area, or in rare diseases, preferred. 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) Experience managing global studies 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 Experience with NDAs, MAA, or other agency new drug application submissions Track record of excellence in effective management of multiple projects / priorities and budgets, ranging from early to late stage development programs Understanding of comprehensive global pharmaceutical regulatory requirements and strategic implications for clinical development operations Demonstrated, effective project management skills Ability to work independently, take a leadership role and drive quality progress Ability to assess complex issues and identify creative, practical solutions Ability to foster effective relationships with vendors, investigators, consultants and colleagues Demonstrated ability to work independently as well as in a team environment Excellent written, oral and presentation communication skills Proficiency in Microsoft Project and / or other project management software and tools and Microsoft Office (Excel, Word, Outlook, PowerPoint) By becoming a team member here at Vor, you'll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, parental leave, and an excellent 401(k) package. We are conveniently located in Boston with easy access to public transportation and ample parking. As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Vor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. Our goal is to bring life-changing therapies to patients worldwide who are living with serious autoantibody-driven conditions. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology. We are advancing Telitacicept, a novel, dual-target recombinant fusion protein that inhibits both BLyS (BAFF) and APRILtwo key cytokines involved in B cell survival and autoantibody production. In a Phase 3 clinical trial in generalized myasthenia gravis in China, Telitacicept demonstrated a 4.8-point improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living scale) vs. placebo at 24 weeks, the primary endpoint of the trial. Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). A global Phase 3 clinical trial in gMG is currently underway across the United States, Europe, and South America to support potential approval in the United States and Europe. Who We Are Looking For:
Vor Bio is seeking a Vice President of Clinical Operations. Primary Responsibilities
Define strategic direction for an integrated project team for all the indication / clinical development programs Lead operational resource planning, implementation, and execution to support multiple global clinical trials Develop, maintain, and report on program budgets, including forecasting in support of financial goals Define and help manage the development of clinical study protocols, documents, procedures, study reports, charters, presentations, and publications Manage clinical study leads / managers and clinical research associates Create team study training, tools and metrics and monitor accordingly Identify outsourcing model best suited for clinical development success Identify vendors, perform capabilities assessments, and conduct formal request proposal process (RFP) including summary evaluation of key factors and bid defense Act as point of contact for escalation management of external vendors and / or CROs Prepare and present key study updates to senior management, and other key stakeholders Involved in building relationships with trial site and KOLs to maximize scientific expertise, patient recruitment and data collection Ensure advocacy and voice of the patient is represented in planning, design and conduct of clinical trials Education and Experience
Bachelor's or master's degree in scientific, biological, life sciences, or related field 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 In-depth knowledge of clinical operations and pharmaceutical drug development process in the autoimmune therapeutic area, or in rare diseases, preferred. 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) Experience managing global studies 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 Experience with NDAs, MAA, or other agency new drug application submissions Track record of excellence in effective management of multiple projects / priorities and budgets, ranging from early to late stage development programs Understanding of comprehensive global pharmaceutical regulatory requirements and strategic implications for clinical development operations Demonstrated, effective project management skills Ability to work independently, take a leadership role and drive quality progress Ability to assess complex issues and identify creative, practical solutions Ability to foster effective relationships with vendors, investigators, consultants and colleagues Demonstrated ability to work independently as well as in a team environment Excellent written, oral and presentation communication skills Proficiency in Microsoft Project and / or other project management software and tools and Microsoft Office (Excel, Word, Outlook, PowerPoint) By becoming a team member here at Vor, you'll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, parental leave, and an excellent 401(k) package. We are conveniently located in Boston with easy access to public transportation and ample parking. As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.