Vice President, Clinical Operations

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)