Associate Portfolio Valuation & Analytics

Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms. It can change the course of disease. 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. When you join Vor, you’re not just working on a medicine. You’re part of a mission to redefine the future of autoimmune care. Why Work at Vor? Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases. Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond. Innovation: Work on a platform with potential beyond one indication — a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren’s syndrome. Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies.     Who we are looking for: 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 successful candidate will report to the Vice President, Clinical Operations. 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. Key areas of 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 * Ensure clinical trials comply with ICH/GCP guidelines, regulations, and company SOPs * 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 * Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team * 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 * Assist in forecasting clinical trial material and ancillary supplies * Represent Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensure compliance with operational standards and procedures * Ensure timely review of protocol deviations and assess the impact on study data * Along with other Clinical Development personnel, represent Vor Biopharma externally to Investigators, site staff, and Key Opinion Leaders * Perform and document study level Sponsor Oversight of outsourced clinical activities * Communicate study status, cost, and issues to ensure timely decision-making by senior management * 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 * Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise * 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 * Participate and respond to Quality Assurance and/or regulatory authority inspection audits * Facilitate the development of trial budgets and execution of clinical trial agreements and other relevant documents in conjunction with CRO and appropriate internal stakeholders * Manage the clinical trial budget and provide financial reporting and projections to Finance * Lead creation of scope of work and budgets and escalate vendor performance issues to Head of Clinical Operations and Outsourcing as necessary Qualifications: * BA or BS in a scientific, life science, or health-related discipline; advanced degree preferred * 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 in setup, execution, and oversight/operational management of autoimmune trial experience - Sjogren's and/or Myasthenia Gravis experience preferred * Experience working on late-stage studies (Phase II, III) * Excellent communication, writing, and presentation skills with strong problem-solving ability and attention to detail * 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 * Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry The salary range for this position is expected to be between $195,000 and $220,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location. At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond. 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. Please visit our website at https://www.vorbio.com/ for more information.

Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms. It can change the course of disease. 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. When you join Vor, you’re not just working on a medicine. You’re part of a mission to redefine the future of autoimmune care. Why Work at Vor? Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases. Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond. Innovation: Work on a platform with potential beyond one indication — a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren’s syndrome. Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies.   Location: Boston, MA preferred Associate Director, Drug Product Technical Operations  Position Summary  We are seeking an Associate Director, Drug Product Technical Operations to lead the technical and operational execution of drug product activities across Vor's external manufacturing network.   This role will have end-to-end accountability for drug product manufacturing from late-stage development through commercialization, including manufacturing strategy, technology transfer, aseptic fill-finish, process validation, lifecycle management, commercial readiness, and Drug Product Module 3 content.   You will operate at the intersection of technical operations, manufacturing, Quality, Regulatory, Supply Chain, Clinical, and external partner execution. You will serve as the technical owner for Drug Product activities while also driving day-to-day operational execution, with direct impact on product quality, regulatory timelines, supply continuity, and commercial launch readiness.  Roles and Responsibilities  Drug Product Technical Leadership: Serve as the technical owner for drug product development and manufacturing activities across formulation, compounding, sterile filtration, aseptic fill-finish, visual inspection, container closure systems, and packaging. Apply technical judgment to define manufacturing approaches, evaluate process performance, and resolve complex drug product issues.  Manufacturing Operations: Lead planning, readiness, and execution of engineering, clinical, validation, and commercial manufacturing campaigns across external manufacturing sites. Ensure materials, documentation, equipment, methods, and cross-functional decisions are in place to support successful and timely campaign execution.  CMC Strategy: Partner with senior leadership to define and execute the Drug Product CMC strategy across development and commercialization. Support decisions related to manufacturing network design, scale-up, process changes, regulatory strategy, technical risk, supply continuity, and lifecycle management.  Process Validation and Commercial Readiness: Lead development and execution of drug product validation strategies, including engineering runs, media fills, process performance qualification, hold-time studies, shipping studies, cleaning validation, and continued process verification. Drive readiness for BLA submission, pre-approval inspection, commercial launch, and routine supply.  Technology Transfer and Lifecycle Management: Lead drug product technology transfers, process scale-up, site transfers, process improvements, and post-approval changes. Ensure technical requirements, knowledge transfer, comparability considerations, validation needs, and regulatory impacts are clearly defined and executed.  Module 3 and Regulatory CMC Ownership: Lead authoring, technical review, and maintenance of Drug Product Module 3 content for INDs, BLAs, supplements, and global regulatory submissions. Partner with Regulatory Affairs and Quality to ensure manufacturing descriptions, process controls, validation strategies, comparability assessments, container closure information, and supporting technical documentation are complete, consistent, and submission-ready.  Health Authority and Inspection Support: Support health authority meetings, information requests, regulatory responses, audits, and inspections. Provide clear technical rationale for manufacturing strategies, process changes, validation approaches, deviations, and risk assessments.  External Partner Management: Serve as Vor's primary technical and operational interface with Drug Product CDMOs, testing laboratories, and other external partners. Lead technical governance meetings, establish clear expectations, track commitments, and drive timely resolution of risks, issues, and dependencies.  Manufacturing Documentation: Review and approve, as appropriate, master and executed batch records, protocols, reports, specifications, change controls, deviations, investigations, CAPAs, risk assessments, validation documents, and campaign summaries. Ensure documentation is technically sound, controlled, and inspection-ready.  Deviation and Investigation Leadership: Provide technical leadership for manufacturing deviations, atypical results, batch-impact assessments, root cause investigations, and corrective and preventive actions. Ensure issues are escalated appropriately and resolved using data-driven and risk-based approaches.  Drug Product and Combination Product Integration: Partner closely with the Combination Product Development Lead to ensure alignment between drug product characteristics, primary container systems, prefilled syringes, needle safety devices, autoinjectors, fill-finish processes, device performance, and product presentation requirements.  Cross-functional Collaboration: Partner across Supply Chain, Quality, Regulatory, Clinical, Commercial, Combination Product, Alliance Management, and Program Management to align technical strategy, manufacturing execution, regulatory deliverables, and program milestones.  Program Management: Own Drug Product timelines, technical risks, decisions, dependencies, and deliverables. Maintain integrated plans and trackers in Smartsheet and communicate progress through clear timeline views using Office Timeline. Ensure actions, decisions, and documentation are accurate, traceable, and inspection-ready.  Skills and Competencies  Drug Product Expertise: Strong technical understanding of biologic drug product development and manufacturing, including formulation, aseptic processing, fill-finish, container closure systems, visual inspection, process validation, and commercial manufacturing.  Technical and Operational Ownership: Ability to combine technical depth with strong operational execution. Demonstrated ability to independently lead complex activities, manage multiple priorities, and drive programs from strategy through execution.  CMC and Regulatory Knowledge: Strong working knowledge of global CMC requirements, Module 3 authoring, process validation, comparability, lifecycle management, and inspection readiness.  External Manufacturing Leadership: Proven ability to manage CDMOs and external laboratories, establish accountability, influence partner performance, and resolve technical and operational issues in an outsourced manufacturing model.  Education, Experience and Qualifications  * Bachelor's degree in engineering, pharmaceutical sciences, chemistry, biotechnology, life sciences, or a related discipline; advanced degree preferred.  * 8-12+ years of experience in biologics drug product development, manufacturing, technical operations, process engineering, or CMC.  * Demonstrated experience leading aseptic fill-finish activities from development and engineering through process validation and commercial readiness.  * Experience leading drug product technology transfers, process scale-up, process validation, manufacturing investigations, change controls, and lifecycle management activities.  * Demonstrated experience authoring and reviewing Drug Product Module 3 sections and supporting regulatory submissions, health authority responses, or inspections.  * Experience managing CDMOs and external technical partners in a GMP-regulated and highly outsourced manufacturing environment.  * Strong understanding of GMP requirements, aseptic processing, validation principles, deviation management, root cause analysis, CAPA, and risk management.  * Experience with injectable biologics, prefilled syringes, container closure systems, visual inspection, and combination products is strongly preferred.  * Experience supporting BLA readiness, process performance qualification, commercial launch, and post-approval manufacturing changes is preferred.  * Strong organizational, program execution, and documentation management skills.    The salary range for the Associate Director, Drug Product Technical Operations is expected to be between $170,000 and $195,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.   At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond. 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. Please visit our website at https://www.vorbio.com/ for more information.