Location: Boston, MA- Hybrid

Who we are looking for:

Vor Bio is seeking a motivated Senior Accountant to join a growing and dynamic team. As a key member of the Finance team, the Senior Accountant will primarily be responsible for the finance department's day-to-day operations, including preparing journal entries, monthly close documentation, payroll administration, controls implementation, and ad hoc finance tasks. This position requires an organized and highly motivated team player with strong initiative and communication skills. We are seeking an experienced candidate with an understanding of the full cycle monthly close and accounts payable process. The finance team is currently working onsite in the Cambridge office 3 days per week.

Key areas of responsibility:

· Key preparer of monthly journal entries, reconciliation schedules, and close documentation

· Responsible for most aspects of the financial reporting processes

· Timely completion of balance sheet reconciliations and analyses related, but not limited to, the Company’s cash, credit cards, accruals, prepaids, fixed assets, and investment accounts, as well as oversight of the accounts payable

· Review of P&L accounts to resolve classification issues

· Support weekly payment run and banking assistance (wires and foreign currency purchases)

· Assist with financial, tax, and controls audits and reviews

· Operate in accordance with a strong internal control environment, and identify areas where you can make improvements to the control environment

· Work with the team on establishing appropriate processes leading to SOX compliance processes

· Other ad hoc reporting tasks as needed (including assisting in the compilation and review of Forms 10-K and 10-Q)

Skills and requirements:

· Bachelor’s degree in accounting or similar field preferred, with 3-5 years of experience, preferably in the life science and/or healthcare industry

· Knowledge of US GAAP and relevant accounting and financial concepts are required

· Strong organizational skills, aptitude for problem-solving, and an ability to provide professional customer service to internal and external customers

· Must be able to manage workload and prioritize as necessary to meet deadlines while exhibiting strong attention to detail

· Ability to interact with co-workers and various levels of management as needed

· Excellent computer skills, including the Microsoft Office Suite with explicit proficiency in Excel

· Experience with Oracle Fusion preferred

· Experience with Prendio procurement system preferred

· Experience with Paylocity preferred

· Big 4 public accounting experience preferred

· CPA license or similar preferred, but not required

· Enjoy working in a fast-paced environment

The salary range for the Senior Accountant is expected to be between $105,000 and $125,000 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.

Location: Boston, MA preferred

The salary range for the Director, Regulatory Strategy is expected to be between $210,000 and $235,000 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.

Location: Boston, MA preferred

• Strategy & Leadership
• Define and execute bioanalytical and biomarker strategies across preclinical and clinical programs
• Align biomarker plans with clinical, regulatory, and development objectives
• Serve as a subject matter expert in bioanalysis and translational biomarkers
• Assay Development & Oversight
• Oversee development, validation, and implementation of bioanalytical assays (e.g., PK, ADA, cell-based, molecular assays)
• Guide biomarker assay selection and fit-for-purpose validation strategies
• Ensure assay performance meets regulatory and scientific standards
• Vendor & Study Management
• Select and manage CROs and external labs for bioanalytical and biomarker activities
• Oversee timelines, budgets, and deliverables across studies
• Ensure high-quality data generation and timely reporting
• Clinical Study Support
• Partner with Clinical Operations and Clinical Development to integrate biomarker endpoints into study design
• Review and interpret biomarker and PK/PD data to inform program decisions
• Contribute to clinical study protocols, SAPs, and reports
• Regulatory & Compliance
• Ensure compliance with GLP/GCP and regulatory guidance (FDA, EMA)
• Contribute to regulatory submissions (INDs, BLAs, briefing packages)
• Represent bioanalytical/biomarker strategy in regulatory interactions as needed
• Cross-functional Collaboration
• Work closely with Translational Sciences, Clinical Pharmacology, Regulatory, and CMC teams
• Communicate complex data and insights to internal stakeholders and leadership

• PhD in Biology, Pharmacology, Immunology, Bioanalytical Sciences, or related field (or MS with significant experience)
• 10+ years of experience in bioanalysis and/or biomarker development in biotech/pharma
• Deep expertise in bioanalytical assays (e.g., LC-MS/MS, ELISA, flow cytometry, qPCR, NGS, cell-based assays)
• Strong understanding of PK/PD, immunogenicity, and translational science principles
• Experience supporting clinical-stage programs and regulatory filings
• Proven track record managing CROs and external partnerships
• Strong leadership, communication, and project management skills

• Experience in [oncology, cell/gene therapy, immunology — tailor as needed]
• Familiarity with companion diagnostics or advanced biomarker platforms
• Prior team leadership or people management experience

The salary range for the Director, Bioanalytical / Biomarkers is expected to be between $210,000 and $230,000 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.

Location: Boston, MA preferred

The Associate Director, Clinical Data Management (CDM) is an individual contributor and leadership role within Vor's Biometrics organization, responsible for strategic oversight and operational delivery of all clinical data management activities across Vor's clinical portfolio. This individual will serve as one of Vor's internal CDM experts leading study and program-level data governance, owning EDC architecture and data standards, managing CRO and vendor partnerships, and ensuring continuous regulatory inspection readiness. 

This role will be accountable for department-level strategy, SOP ownership, regulatory inspection representation as a named CDM subject matter expert, and cross-regional data integration from multi-national studies. The Associate Director serves as a senior escalation point and represents the CDM function at program governance forums and regulatory interactions. 

Key Responsibilities 

1. CDM Strategy & Portfolio Oversight 

• Contribute to the strategic and operational leadership for multiple CDM activities across Vor's clinical portfolio, from protocol synopsis through database lock, archiving, and regulatory submission. 

• Serve as the CDM functional lead on program teams, contributing to clinical development plans, protocol design, and study feasibility assessments from a data quality and operability perspective. 

• Define and communicate CDM strategy, standards, and milestone timelines at the study and program level; identify risks early and communicate mitigation plans to senior leadership. 

• Partner with Biostatistics and Statistical Programming to ensure seamless data flow from EDC through SDTM/ADaM datasets and downstream regulatory analyses. 

2. EDC Platform Ownership & Data Standards — Medidata Rave 

• Serve as Vor's primary subject matter expert (SME) and platform owner for Medidata Rave EDC, governing the full ecosystem: study build, library management, edit check strategy, change control, and system validation. 

• Lead development and governance of Vor's CDASH-aligned CRF standards library within Medidata Rave — ensuring consistency, reusability, version control, and regulatory/submission alignment across all programs. 

• Oversee CRF design, database build specifications, UAT strategy, and production release quality control across all active studies. 

• Ensure EDC configurations comply with CDISC CDASH/SDTM standards, facilitating optimal downstream dataset programming for regulatory submissions. 

• Evaluate and implement emerging Medidata capabilities (e.g., eConsent, eCOA integrations, Medidata AI data monitoring) to advance quality and operational efficiency. 

• Maintain governance of edit check specifications, data review guidelines, and coding conventions (MedDRA, WHODrug) across all Vor studies. 

3. Cross-Regional Data Integration & Bridging Studies 

• Lead the CDM strategy for multi-regional clinical trials, including studies with non-US-originated or non-US-concurrent data (e.g., bridging studies, ICH E17-compliant global programs). 

• Oversee data transfer, reconciliation, and harmonization from non-US regional CROs and data platforms, ensuring data integrity when integrating datasets from non-US investigational sites or partners into global submissions. 

• Partner with Regulatory Affairs and Biostatistics to define data requirements for integrated global analyses and data pooling strategies (per ICH E17) for FDA and EMA submissions. 

• Ensure regional data collection practices — including eCRF language localization, coding dictionary alignment, and site training materials — satisfy both local regulatory requirements and Vor global data standards. 

• Manage data transfer specifications and reconciliation protocols for all third-party data streams: central labs, IRT, safety databases, eCOA, and regional CRO-generated datasets. 

4. Regulatory Inspection Readiness & Direct Inspection Representation 

• Ensure Vor's CDM documentation, TMF data management sections, and EDC audit trails are maintained in a state of continuous inspection readiness throughout the study lifecycle. 

• Serve as the CDM subject matter expert and primary spokesperson in regulatory inspections (FDA, EMA, competent authority), audits, and quality reviews — directly answering inspector and auditor questions on data management practices, EDC systems, data integrity, and audit trail review. 

• Prepare CDM inspection packages including data management plans, system validation documentation, audit trail narratives, and data quality metrics for regulatory review. 

• 5. CRO & Vendor Management 

• Serve as Vor's senior CDM oversight lead for external CRO DM partners — including contract scope definition, performance governance, issue escalation authority, and quality review. 

• Establish and enforce CDM expectations, SOW deliverables, and quality metrics for all external vendors: CROs, EDC service providers, central labs, IRT vendors, and eCOA/ePRO platforms. 

• Review and approve all key DM vendor deliverables: data management plans, CRF completion guidelines, edit check specifications, data transfer agreements, and database lock packages. 

• Lead vendor qualification activities and contribute to CRO selection processes as a CDM technical evaluator. 

6. Quality, Compliance & SOP Governance 

• Develop, maintain, and continuously improve Vor's CDM SOPs, work instructions, templates, and data management plans in alignment with ICH E6(R3), FDA 21 CFR Part 11, EU Annex 11, GCDMP, and CDISC standards. 

• Ensure compliance with electronic records and electronic signatures regulations across all EDC systems and data management platforms. 

• Track and report data quality metrics, query resolution rates, cleaning milestones, and database lock timelines to program teams and leadership. 

7. Cross-Functional Collaboration 

• Collaborate closely with Biostatistics, Statistical Programming, Clinical Operations, Regulatory Affairs, Medical Writing, and Safety to ensure CDM activities support all downstream deliverables. 

• Partner with Clinical Operations on site training, data entry guidance, and site data quality monitoring. 

• Provide CDM input into clinical study reports, regulatory briefing documents, and submission-ready data packages. 

• Represent CDM on study teams, program governance boards, and senior leadership forums. 

8. Leadership & Talent Development 

• Provide mentorship, technical guidance, and professional development support to Sr. Data Managers and Data Managers within the CDM team. 

• Contribute to workforce planning and hiring, helping define and scale CDM capabilities as Vor's pipeline grows. 

• Foster a high-performance, quality-first team culture aligned with Vor's clinical mission. 

Qualifications 

Education 

• Bachelor's degree in Life Sciences, Health Informatics, Computer Science, or related field required. 

• Advanced degree (Master's or equivalent) preferred. 

• CCDM (Certified Clinical Data Manager) certification is a plus. 

Required Experience 

• Minimum 10 years of clinical data management experience in pharmaceutical, biotech, or CRO settings, with at least 3 years in a senior lead or management role. 

• Expert-level proficiency with Medidata Rave EDC — including study build, CRF design, edit check authoring, library management, UAT oversight, and production release governance. 

• Demonstrated prior experience as the named CDM representative in FDA or EMA regulatory inspections — directly answering inspector questions on data management practices, audit trails, and data integrity. 

• Hands-on experience with multi-regional clinical data management including integration of data from China-based or other non-US studies, data transfer reconciliation, and bridging study data strategies. 

• Deep knowledge of CDISC standards (CDASH, SDTM), ICH guidelines (E6, E8, E9, E17), FDA 21 CFR Part 11, EU Annex 11, and GCDMP. 

• Proven CRO and vendor oversight experience across full study lifecycles from startup through database lock and archiving. 

• Proficiency with coding dictionaries (MedDRA, WHODrug) and data review/cleaning methodologies. 

Preferred Experience 

• Background in autoimmune disease and/or rare disease is a plus.  

• Prior experience with front-line communications during regulatory inspections.  

• Prior experience building or scaling a CDM function in a lean, clinical-stage biotech environment. 

• Familiarity with eSource, decentralized trial (DCT) components, and real-time data monitoring technologies. 

• Experience with Medidata Rave Architect and/or Rave EDC Modules (eConsent, eCOA, Medidata AI). 

• Working knowledge of R/R Shiny/Posit Connect or other similar tools for data quality review, reconciliation, and dashboards is a plus.  

Skills & Competencies 

• Demonstrated ability to communicate complex data management concepts clearly and concisely — both in polished written deliverables and confident oral presentations — to diverse audiences including clinical teams, regulatory inspectors, senior leadership, and external partners. 

• Strategic thinking with the ability to anticipate downstream data quality and submission risks and take proactive, documented action. 

• Exceptional attention to detail combined with ability to manage multiple concurrent programs under tight timelines. 

• Ability to lead and influence cross-functionally without requiring direct authority over all stakeholders. 

• Comfort operating hands-on in a lean, fast-paced clinical-stage biotech alongside strategic departmental oversight. 

• Strong vendor management and project delivery track record for high-quality data packages on time. 

• Collaborative, patient-centered mindset aligned with Vor's mission. 

The salary range for the Associate Director, Clinical Data Management is expected to be between $185,000 and $210,000 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.

Location: Boston, MA preferred

The Senior Data Manager is responsible for all data management activities from study start-up through database lock and archiving and independently supporting the needs of the clinical study and programs of studies.  The Senior Data Manager will ensure completeness, accuracy and consistency and meet the standards of quality analysis and reporting to regulatory bodies.  In addition, the Senior Data Manager has an active role in continuous improvement and acts as a leader in the department as demonstrated by successful mentoring and consistent study delivery over time. 
 
Responsibilities: 
 

• Serves as data lead for one or more clinical trials, assuming responsibility for all data management activities, including access levels and permissions. 

• Proactively drive quality and efficiency to meet timelines and milestones for data management in close collaboration with cross functional study team(s) 

• Conduct oversight of data management activities internally and performed by the CROs and other 3rd party vendors (IRT, Safety, Lab, etc.) to meet Vor obligations and business objectives throughout study (ies) life cycle i.e. from protocol synopsis through database release and submission. 

• Serve as a first point of contact for DM partners to ensure established milestones and deliverables are met with the highest degree of quality 

• Ensure the internal and external partners align and conform to data management expectations for the assigned compound and/or indication. 

• Review and provide input for all DM documentation - CRF design and completion Guidelines, Data Management Plan, Data Transfer Specifications, etc. 

• Oversee edit check specifications to support data collection and analysis required per protocol. 

• Ensure the clinical database adheres to Clinical Data Acquisition Standards Harmonization guidelines allowing for optimal SDTM dataset programming. Suggest design for standard and non-standard data collection, identify any gaps in data collection, and challenge collection of unnecessary data. 

• Participate in the creation of the clinical development plan, describing the clinical development strategy and possible innovative trial designs.  

• Set quality expectations and timelines for data management deliverables and regularly follow up on data management milestones.  Ensure inspection readiness at all times. 

• Set expectations and communicate and a transparent, clear way and motive team members to work towards achieving the clinical goals. 

•  Follow department and company standard operating procedures (SOPs), forms, templates and policies. Provide feedback and update these guidelines as needed. 

•  Develop, review, and maintain all study Data Management documentation. 

• Take responsibility for and guide effective quality control (QC) review and user acceptance testing (UAT) of the clinical database prior to its release into production, including oversight of staff performing these tasks. 

•  Ensure data are properly reviewed in accordance with the Data Management Plan (DMP) and guidelines and that cleaning is effective and timely. 

• Provide input on study timelines, identify risks, and communicate mitigation strategies to the Project Manager. 

•  Provide input into improving the efficiency of data management tasks. 

•  Lead and participate in intradepartmental or interdepartmental process and quality improvement initiatives. 
   
   

Requirements 
 
 

•  Bachelor's Degree in computer sciences, health-related sciences, or relevant field and 7+ years of Data Management experience.  

• Proven hands-on, direct, individual contributor experience with all data management tasks as well as DM vendor oversight to meet aggressive timelines of high-quality data deliverables. 

• Extensive hands-on experience with clinical data management practices within industry sponsored clinical trials. 

• In depth knowledge of industry leading eCRF tools and well versed in industry trends and emerging technologies supporting data collection.  

• Proficient experience using commercial clinical data management systems and/or EDC products e.g. Medidata Rave. Must have Medidata RAVE experience.  

• Strong project management; exhibits expertise in metrics analysis and reporting methodologies. 

• Knowledge of clinical research, FDA & ICH, GCP, GCDMP, related regulatory requirements. 

• Contribute to the growth and development of the DM team. 

• Excellent verbal and written communication skills. 

•  Professional attitude and strong interpersonal skills. 

•  Ability to work well with a multi-disciplinary team of professionals. 

•  Flexible attitude with respect to work assignments and new learning. 

•  Ability to prioritize workload. 

•  Superior attention to detail. 

•  Understanding of clinical research and the relationship of Data Management in the clinical study process. 

•  Strong technical aptitude and ability to adapt to multiple data management platforms. 

•  Strong knowledge of electronic data capture (EDC) clinical data management systems. 

• Strong computer skills (Microsoft Office Suite, Medidata Rave) and ability to understand and adapt to various information technology (IT) systems. 
   

Preferred Requirement(s): 

• Working knowledge of R/R Shiny/Posit Connect or other similar tools for data quality review, reconciliation, and dashboards is a plus.  

The salary range for the Senior Data Manager is expected to be between $170,000 and $190,000 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.

Location: Boston, MA preferred

We are seeking a Senior Manager, Program Management & Drug Substance Lead to support execution of drug substance development and manufacturing programs for biologics. This role combines program management with hands-on understanding of CHO-based manufacturing to ensure activities are well-coordinated, risks are proactively managed, and supply aligns with clinical and commercial needs. 

You will play a key role in advancing programs through late-stage development by working across internal teams and external partners to deliver reliable, scalable drug substance supply. 

 Roles and Responsibilities 

Program Management & Execution: Drive day-to-day program execution across drug substance activities. Develop and maintain integrated timelines, track deliverables, risks, and dependencies, and ensure alignment across CMC, Quality, Regulatory, Clinical, and Supply Chain teams. 

Drug Substance Development & Manufacturing: Support drug substance activities for biologics, including CHO cell line–based processes. Contribute to process development, tech transfer, scale-up, and manufacturing readiness. Partner with technical teams to ensure processes are robust, scalable, and aligned with program timelines. 

External Manufacturing Coordination: Coordinate activities across CDMOs and external partners. Track manufacturing progress, ensure deliverables meet expectations, and escalate risks or issues as needed. Support preparation for manufacturing campaigns and monitor execution. 

Supply Planning Alignment: Partner with Supply Chain to align drug substance manufacturing with clinical and commercial demand. Support planning activities, including production scheduling, inventory tracking, and risk mitigation for supply continuity. 

Risk Management & Issue Resolution: Identify program and technical risks and support development of mitigation plans. Work cross-functionally to resolve manufacturing, process, or supply issues in a timely manner. 

Cross-functional Collaboration: Coordinate across Quality, Regulatory, Clinical, Commercial, and Finance teams to ensure alignment on priorities, timelines, and deliverables. Support regulatory documentation and ensure consistency of CMC information. 

Program & Data Management: Maintain program plans, trackers, and dashboards using tools such as Smartsheet. Ensure timelines, risks, and decisions are accurately captured and communicated through clear updates and reporting. 

 Skills and Competencies 

Program Execution: Strong ability to manage timelines, track deliverables, and drive execution in a fast-paced environment. 

Technical Foundation: Working knowledge of biologics drug substance development, including CHO cell culture, upstream and downstream processes. 

Cross-functional Collaboration: Ability to work effectively across teams and manage competing priorities. 

Problem Solving: Strong analytical mindset with the ability to identify risks and support practical solutions. 

Communication: Clear and organized communicator, able to provide concise updates to stakeholders. 

Education, Experience and Qualifications 

Bachelor’s degree in life sciences, engineering, or related field; advanced degree preferred 

6–10+ years of experience in biologics drug substance development, manufacturing, or CMC program management 

Experience with CHO cell-based manufacturing systems required 

Working knowledge of upstream (cell culture) and downstream (purification) processes 

Experience supporting tech transfer, scale-up, and manufacturing execution 

Experience working with external manufacturing partners (CDMOs) 

Strong program management and data management skills; experience with tools such as Smartsheet preferred 

The salary range for the Senior Manager, Program Management and Drug Substance Lead is expected to be between $155,000 and $175,000 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.

Location: Boston, MA preferred

Associate Director, Combination Product Development Lead 

We are seeking an Associate Director, Combination Product Development Lead to drive development of combination products. This role will have end-to-end accountability for the Design History File (DHF) and will play a central role in advancing device strategy, execution, and readiness for commercialization. 

You will operate at the intersection of device development, drug product, and external partner execution, with direct impact on product quality, program timelines, and patient experience. 

 Roles and Responsibilities 

Combination Product Development: Lead development of combination product systems from late-stage development through commercialization. Translate user needs into product requirements and executable development plans with defined milestones, risks, and timelines. Drive design verification and validation activities, including test strategy, execution, and documentation. Ensure alignment between device design, container closure systems, and fill–finish processes. 

DHF Ownership & Compliance: Own and maintain the end-to-end Design History File / Design Development File (DHF/DDF) across device platforms, ensuring compliance and quality. Partner with Quality to support reviews, audits, and inspection readiness. 

Drug Product Considerations: Apply working knowledge of injectable drug product characteristics, including viscosity, injection forces, and dose delivery, to inform device design and performance. Anticipate and resolve device–drug product interaction challenges to ensure consistent and reliable delivery. 

Risk Management & Usability: Lead risk management activities, including hazard analysis and FMEA, and ensure risks are proactively identified and mitigated. Support human factors and usability efforts to ensure alignment with patient needs and intended use. 

External Partner Management: Manage and coordinate development activities across external vendors and partners. Ensure deliverables meet technical, quality, and timeline expectations and are fully integrated into the DHF and overall development program. Support governance meetings and drive resolution of risks and dependencies. 

Cross-functional Collaboration: Partner across Supply Chain, Quality, Clinical, Commercial, Regulatory, and Manufacturing teams to align on priorities, timelines, and deliverables. Support regulatory submissions by ensuring device and combination product documentation is complete and consistent. 

Program Management: Own program-level tracking of timelines, risks, decisions, and deliverables. Maintain plans and trackers in Smartsheet and communicate progress through clear timeline views using Office Timeline. Ensure documentation is controlled, accurate, and inspection-ready. 

Skills and Competencies 

Combination Product Expertise: Strong understanding of combination product development, design controls, risk management, and verification and validation. 

Execution & Ownership: Ability to operate independently, manage complexity, and drive programs forward with clarity and accountability. 

Cross-functional Leadership: Proven ability to work across functions and align stakeholders in a fast-paced, matrixed environment. 

Problem Solving: Strong analytical and technical problem-solving skills, with the ability to anticipate risks and drive solutions. 

Communication: Clear and effective communicator, able to translate complex technical topics into actionable insights. 

Education, Experience and Qualifications 

Bachelor’s degree in engineering or life sciences; advanced degree preferred 

8–12+ years of experience in combination product, drug–device, or medical device development 

Demonstrated experience owning a Design History File / Design Development File (DHF/DDF) through development and commercialization 

Hands-on experience with parenteral injectors.  

Working knowledge of injectable drug product properties and their impact on device performance 

Experience managing external development and manufacturing partners in a regulated environment 

Strong organizational, program execution, and documentation management skills 

The salary range for the Associate Director, Combination Product Development Lead 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.

The Digital, Data, and Technology (DD&T) organization is seeking a Director of IT Infrastructure, Operations & Security to design, build, and operationalize a scalable, enterprise-grade IT function in an evolving biotech environment. This leader will be responsible for defining and implementing the global Infrastructure, IT Operations, End-User Support, and IT Security capabilities required to support regulated commercialization and corporate operations. 

This role requires a hands-on strategic builder who can architect the operating model, implement foundational governance and controls, and transition the organization from reactive IT support to a proactive, secure, service-oriented global IT function. 

The successful candidate will combine strong technical depth with operational discipline and executive-level communication, ensuring that IT enables scientific innovation while maintaining compliance, security, and scalability. 

Key Responsibilities 

IT Strategy & Operating Model 

• Define and implement the IT Infrastructure, Operations, Global Support, and IT Security organizational structure. 

• Establish a scalable IT service delivery model aligned to biotech growth and regulatory requirements. 

• Develop a 2–3 year technology roadmap covering infrastructure modernization, security maturity, and operational excellence. 

• Implement governance, KPIs, SLAs, and service management frameworks (e.g., ITIL-based processes). 

• Build and manage internal teams and external managed service providers (MSPs). 

Infrastructure & Cloud Services 

• Design and operationalize enterprise infrastructure strategy across: 

• Cloud platforms (e.g., Microsoft Azure or AWS) 

• Hybrid networking and secure connectivity 

• Identity & access management 

• Endpoint management (Windows, macOS, mobile) 

• Ensure high availability, disaster recovery, and business continuity planning. 

• Standardize global site infrastructure for offices and lab environments. 

• Oversee lifecycle management of hardware, software, and core systems. 

IT Operations & Global Support 

• Build a scalable global support model (Service Desk, onsite support, executive support). 

• Implement incident, problem, change, and asset management processes. 

• Define support tiers (L1–L3) and escalation models. 

• Establish a global IT Command Center capability for operational visibility. 

• Improve employee experience through premium, personalized technical support. 

• Manage vendor relationships and outsourced support partners where appropriate. 

IT Security & Compliance 

• Establish and operationalize an enterprise IT security program partnership. 

• Define cybersecurity policies, standards, and technical controls. 

• Implement risk management, vulnerability management, and incident response processes. 

• Ensure compliance with biotech-relevant regulations and frameworks (e.g., GxP, SOX, GDPR, HIPAA as applicable). 

• Partner with Quality and Legal teams on audit readiness and documentation. 

• Develop security awareness and training programs across the organization. 

Financial & Vendor Management 

• Develop and manage IT operating and capital budgets. 

• Rationalize vendor landscape and negotiate enterprise contracts. 

• Drive cost transparency and optimize spend while enabling growth. 

• Evaluate and implement managed service provider (MSP) partnerships where appropriate. 

Required Qualifications 

• 10+ years of progressive IT leadership experience, including building infrastructure and operations functions. 

• Experience in biotech, life sciences, pharmaceutical, or other regulated environments. 

• Proven track record of designing and implementing scalable IT operating models. 

• Deep knowledge of: 

• Cloud infrastructure (Azure, AWS) 

• Enterprise networking and security architecture 

• Endpoint management and identity platforms 

• IT service management frameworks 

• Experience implementing cybersecurity programs and managing regulatory audits. 

• Strong financial acumen with experience managing multi-million-dollar IT budgets. 

• Demonstrated success leading global or multi-site teams. 

• Experience in growth-stage biotech or pre-commercial environments. 

• Familiarity with GxP, validated systems, and laboratory IT environments. 

• CISSP, CISM, ITIL, or relevant technical certifications. 

• Experience transitioning from decentralized IT to centralized global operations. 

 The salary range for the Director IT Infrastructure, Operations and Security is expected to be between $205,000 and $235,000 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.

Location: Boston, MA preferred

The Director, Biostatistics serves as a senior individual contributor to statistical leadership at Vor Biosciences, providing strategic and operational oversight across multiple clinical programs. Reporting to the Head of Biometrics this individual will serve as Vor's global expert in biostatistical science, with accountability for all aspects of clinical trial design, statistical methodology, regulatory submission deliverables, and cross-functional scientific partnership. This is a hands-on, high-impact role in a lean, mission-driven biotech environment where the Director will function as a study and program statistical lead with both technical depth and enterprise-wide strategic influence. 

Key Responsibilities 

1. Statistical Strategy & Clinical Trial Design

• Serve as the study and program-level statistical lead for one or more clinical programs, with end-to-end biostatistical ownership from study design through regulatory submission.
• Develop, author, and co-author statistical analysis plans (SAPs), sample size justifications, randomization strategies, and adaptive or novel trial design frameworks suited to rare disease and small-population contexts.
• Apply innovative statistical methodologies including Bayesian approaches, adaptive designs, andestimandframeworks per ICH E9(R1) to maximize information efficiency in limited-sample studies. 
• Collaborate with Clinical Development, Translational Science, and Clinical Pharmacology to integrate quantitative evidence from early development into late-stage design decisions.
• Provide statistical input to clinical development plans, protocol design, go/no-go decision frameworks, and feasibility assessments.

1. Regulatory Affairs & Submission Leadership

• Author and review statistical sections of regulatory documents including INDs, investigator brochures, briefing books, CSRs, and eCTD/CTD module submissions to FDA, EMA, and other health authorities.
• Represent Vor's Biostatistics function, asappropriate, in regulatory agency meetings (FDA Type A/B/C meetings; EMA scientific advice), preparing statistical positions and responding to agency questions.
• Ensure compliance with applicable ICH guidelines (e.g.,E6, E8, E9, E9(R1), E10, E17) and FDA/EMA statistical guidance documents throughout the clinical development lifecycle.
• Maintaincurrent knowledge of evolving regulatory expectations for rare disease programs, including implications of Orphan Drug and Breakthrough Therapy designations on study design and evidence standards. 

1. Data Analysis, Reporting & Integrity

• Oversee execution of all statistical analyses including interim analyses,primary/finalanalyses, safety reviews, and ad hoc requests, ensuring accuracy, reproducibility, and regulatory compliance. 
• Lead generation and review of Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory packages, working closely with statistical programming.
• Review and approve CDISC-compliant SDTM andADaMdataset specifications, define.xml documents, and reviewer's guides for regulatory submissions. 
• Oversee IDMC/DSMB activities including charter and SAP development, preparation of unblinded analyses, and coordination with independent statisticians.
• Ensure all statistical deliverables meet ICH E3 (CSR structure), CDISC, and applicable FDA/EMA technical standards.

1. Cross-Functional Collaboration

• Partner with Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, Safety, and Medical Writing to embed statistical rigor throughout the study lifecycle.
• Collaborate with Data Management on CRF design, data validation rules, database structures, andeCOA/ePRO platform specifications.
• Provide statistical input to publication strategies, scientific communications, and clinical evidence planning in partnership with Medical Affairs.

1. Vendor & CRO Oversight

• Serve as Vor's statistical representative in the selection, qualification, and oversight of CROs, statistical programming vendors, IRT providers, andeCOAplatforms. 
• Review and approve vendor-generated statistical deliverables for scientific quality, compliance, and timeliness; escalate and resolve issues proactively to protect program timelines and data integrity.

1. Standards, Infrastructure & Innovation

• Contribute to the development and maintenance of Vor's internal biostatistical standards, SOPs, templates (SAP, DMC charter, analysis specifications), and best practices.
• Champion adoption of modern statistical methods including Bayesian analysis, real-world data integration, model-based drug development, and simulation-based sample size approaches.
• Stay current with regulatory guidance, methodological advances, and industry benchmarks to continuously elevate Vor's statistical capabilities.

1. Leadership & Talent Development

• Provide mentorship and technical guidance to junior biostatisticians and cross-functional data scientists within the Biometrics organization.
• Contribute to workforce planning including defining resourcing needs and supporting recruitment and development of talent as Vor's pipeline expands.
• Foster a culture of scientific rigor, continuous learning, and collaborative excellence.

Qualifications 

Education 

• PhD in Biostatistics, Statistics, or a closely related quantitative discipline strongly preferred.
• Master's degree (MS/MA) in Biostatistics or Statistics with extensive industry experience may be considered.

Required Experience 

• Minimum 10 years of pharmaceutical/biotech industry experience in clinical biostatistics, with at least 5 yearsina senior or program-lead capacity. 
• Demonstratedprogram-level statistical ownership from protocol design through regulatory submission (IND, NDA/BLA, or MAA). 
• Hands-on experience with adaptive designs, Bayesian methods, or novelestimandframeworks (ICH E9(R1)). 
• Track record of direct FDA and/or EMA interaction, including preparation and response to agency queries.
• Experience managing CRO statistical and programming relationships and vendor deliverable quality.
• Proficiencyin SAS (required); R strongly preferred; Python or additional statistical languages a plus. 
• Familiarity with CDISC standards (SDTM,ADaM), eCTD submission requirements, and reviewer's guide preparation.

• Prior experience at a clinical-stage biotech with responsibility for building or scaling a biometrics function. 

Preferred Experience 

* Experience in rare disease or immunology drug development.  

• Experience with small-sample trial design methodologies (e.g., single-arm studies, external control arms,historical data integration).

Skills & Competencies 

• Demonstratedability to communicate complex statistical concepts clearly and concisely to diverse audiences — including clinical, regulatory, and executive stakeholders — through both compelling written deliverables and confident oral presentations. 
• Exceptional statistical reasoning with ability to translate complexmethodologyinto clear language for non-statistical audiences. 
• Strong leadership and cross-functional influence without requiring direct line authority over all stakeholders.
• Comfortoperatingin a lean, fast-paced biotech with hands-on execution alongside strategic thinking. 
• Ability to build statistical processes, standards, and infrastructure from theground up.
• Excellent written and oral communication; effective across regulatory, executive, and scientific forums.
• Strong project management skills; able to manage multiple programs simultaneously under tight timelines.
• Collaborative, patient-centered mindset aligned with Vor's mission in hematologic disease.

The salary range for the Director, Biostatistics is expected to be between $230,000 and $250,000 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.

Vice President, Disease Area Leader – Neuromuscular Disease

Reports to: Chief Medical Officer

Position Summary

The Vice President, Disease Area Leader – Neuromuscular Disease is the strategic and operational leader for late-stage clinical development in the company’s neuro-immunology portfolio. This executive owns the end-to-end development strategy, drives pivotal-stage execution, and ensures programs are positioned for regulatory approval and commercial readiness and launch. This role operates as a senior strategist, manager, and hands-on clinical leader, directly shaping study design, data interpretation, regulatory interactions, and cross-functional alignment. The VP, Disease Area Leader will also be the externally facing voice for the asset to medical and scientific community.

Key Responsibilities

Strategic Leadership

· Define and lead the late-stage development strategy for neuroimmunology programs, ensuring clear differentiation and regulatory readiness.

· Drive portfolio prioritization and scenario planning with a pragmatic, resource-conscious approach.

· Serve as the company’s senior expert in neuro-immunology, integrating emerging science, competitive intelligence, and patient insights.

Late-Stage Clinical Development

· Lead design and execution of registration-enabling and planning for post-registrational studies, balancing scientific rigor with operational feasibility.

· Provide senior medical oversight of clinical team members for ongoing trials, including safety review, data interpretation, and benefit-risk assessments.

· Partner closely with Clinical Operations to troubleshoot issues, accelerate timelines, and ensure high-quality study conduct across a small, agile team.

· Oversee development of statistical analysis plans, endpoint strategies, and data packages for regulatory and commercial use.

Regulatory Strategy & Interactions

· Contribute to global regulatory strategy for late-stage programs, including preparation of briefing documents, pivotal submissions, and labeling negotiations.

· Lead clinical interactions with FDA, EMA, and other agencies, ensuring clear, evidence-based communication.

· Anticipate regulatory risks and proactively develop mitigation strategies.

Cross-Functional Leadership in a Lean Environment

· Lead clinical and cross-functional development teams

· Partner with Medical Affairs, HEOR, and Commercial to assure KOL engagement and align evidence generation with launch readiness and payer expectations.

· Collaborate with CMC, Quality, and Manufacturing to ensure late-stage readiness and supply continuity for pivotal studies.

· Represent the disease area at executive governance forums with crisp, data-driven recommendations.

External Engagement

· Build and maintain relationships with key opinion leaders, investigators, and patient advocacy groups in neurology and immunology.

· Lead advisory boards, scientific congress planning, and publication strategy for late-stage programs.

· Serve as a senior external representative for the company’s neuro-immunology pipeline.

Organizational Leadership

· Mentor and develop a high-performing clinical team including medical and scientific directors.

· Foster a culture of urgency, scientific excellence, and collaborative problem-solving.

· Contribute to broader R&D leadership initiatives and capability building.

Qualifications

· MD or MD/PhD with deep experience in neuromuscular disease and neuro-immunology.

· 12–18+ years of industry experience, including leadership of late-stage clinical programs; small-biotech experience strongly preferred.

· Demonstrated success leading Phase 2b/3 or registration-enabling studies.

· Proven track record interacting with global regulatory agencies.

· Strong understanding of neuro-immunology disease biology, patient populations, and evolving therapeutic landscapes.

· Ability to thrive in a fast-paced, resource-lean environment with shifting priorities.

· Exceptional communication and executive-level influence skills.

Success Profile

· Strategic yet hands-on leader who excels in lean biotech settings.

· Deep neuro-immunology expertise with a pragmatic approach to late-stage execution.

· Decisive, data-driven, and comfortable navigating ambiguity.

· Collaborative executive who builds alignment quickly across small, cross-functional teams.

· Driven by scientific rigor, patient impact, and operational excellence.

The salary range for the Vice President, Disease Area Lead-Neuromuscular Disease is expected to be between $390,000 and $425,000 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.