Vor Bio

Vor Bio

Associate Director Clinical Operations

Boston, MA · Director

Sponsorship not specifiedDetected 7 hours ago
GCPFinancial AnalysisForecastingClinical TrialsClinical ResearchResearchLeadershipCommunicationCollaborationProblem SolvingMentoringOrganizational SkillsMicrosoft OfficeFinancial Reporting

About the role

  • When you join Vor, you're not just working on a medicine.
  • Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases.
  • The successful candidate will report to the Vice President, Clinical Operations.

Responsibilities

  • 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
  • Develop operational strategy and clinical operations plans to support the execution of the Clinical Development Plan
  • Support the selection, oversight, and management of CROs and other vendors
  • 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
  • Manage the cross-functional team and CRO/vendor(s) related to all aspects of clinical trial operations
  • Perform and document study level Sponsor Oversight of outsourced clinical activities
  • Oversee/collaborate and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
  • Develop and foster strong, collaborative relationships with key stakeholders both within and external to Vor Biopharma
  • Support program level deliverables/activities at the discretion of the Head of Clinical Operations
  • 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

Requirements

  • 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
  • Experience working on late-stage studies (Phase II, III)
  • 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
  • Solid working knowledge of ICH/GCP guidelines and the application to the conduct of clinical trials
  • Proficient in MS Office Suite and understanding of Clinical Trial Management System, eTMF, and EDC systems, as required
  • Ability/willingness to travel as required
  • We invite you to come as you are.
  • Experience in setup, execution, and oversight/operational management of autoimmune trial experience
  • BA or BS in a scientific, life science, or health-related discipline; advanced degree preferred
  • Excellent communication, writing, and presentation skills with strong problem-solving ability and attention to detail
  • Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry

Nice to have

  • advanced degree preferred
  • Experience in setup, execution, and oversight/operational management of autoimmune trial experience - Sjogren's and/or Myasthenia Gravis experience preferred
  • Sjogren's and/or Myasthenia Gravis experience preferred

Compensation

  • The salary range for this position is expected to be between $195,000 and $220,000 per year.

Company info

  • Vor Biopharma is seeking an Associate Director of Clinical Operations to manage our 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 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.
  • 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.
  • Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond.
  • At Vor, we believe science can do more than manage symptoms.
  • By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades.
  • Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide.
  • You're part of a mission to redefine the future of autoimmune care.

Visa & Work Authorization

  • Perform and document study level Sponsor Oversight of outsourced clinical activities
Apply directly at Vor Bio →Create a free account for alerts like thisView Vor Bio immigration profile

This listing is sourced directly from Vor Bio's careers page and normalized into a canonical job model.