Pulmovant

Program Manager

• Lead and manage supporting PH-ILD studies, including Phase 1, biomarker, population PK, and nonclinical studies
• Deliver studies on time, on budget, and to agreed quality standards through integrated project plans
• Resolve issues and risks with team members and program stakeholders, escalating when necessary
• Interact with cross-functional team representatives, Pulmovant program management members, and external partners
• Establish and integrate program management tools, processes, initiatives, and documentation
• Support cross-functional program planning, execution, monitoring, tracking, and reporting
• Own day-to-day program management for supporting PH-ILD studies
• Manage meeting and communication records, including agendas, minutes, charters, dashboards, and reports
• Communicate effectively and manage time to meet stakeholder expectations

Senior Manager, Program Management, PH-ILD

Manager

• Develop, validate, and maintain SAS and R programs to produce CDISC-compliant SDTM and ADaM datasets, tables, listings, and figures (TLFs) for clinical studies and regulatory submissions
• Serve as lead programmer for assigned Phase 2b/3 studies; author and review programming specifications, QC plans, and define.xml files
• Ensure all deliverables are audit-ready and aligned with SAPs, protocols, and applicable FDA/EMA/ICH regulatory guidelines
• Contribute to the development and maintenance of reusable SAS macro libraries, R packages, and programming standards
• Lead or support statistical programming activities for NDA/BLA/IND submissions, including integrated summaries of safety (ISS) and efficacy (ISE), CSRs, and ad hoc regulatory requests
• Ensure compliance with CDISC SDTM/ADaM implementation guides, FDA Data Standards Catalog, and eCTD submission requirements; author and review Reviewer's Guides and define.xml
• Review and provide input on eCRF designs, external data transfer specifications, central lab/imaging specifications, and protocol deviation plans
• Represent Statistical Programming at study team meetings; collaborate with Biostatisticians, Data Management, Medical Writing, Clinical Operations, and Regulatory Affairs
• Plan and manage programming timelines and resources; oversee and quality-check deliverables from CROs and external programming vendors
• Contribute to or lead departmental SOPs, work instructions, and process improvement initiatives
• Mentor junior statistical programmers; provide technical guidance, code review, and professional development support
• At the Senior Manager level, may manage 1–2 direct reports and provide input on hiring, performance, and team-building

Manager/Senior Manager, Statistical Programming

• Execute clinical supply chain activities supporting Pulmovant clinical studies globally
• Coordinate clinical packaging, labeling, and distribution operations
• Manage inventory and logistics for the clinical program
• Serve as the subject matter expert for clinical drug supply throughout all clinical trial phases
• Support implementation of global clinical inventory management, supply planning, and distribution systems
• Manage vendors and performance metrics
• Support clinical supply activities for ongoing and new clinical trials, including protocol demand forecasting, pharmacy manual drafting, trial monitoring, initial and resupply planning, and distribution
• Coordinate with Clinical Operations, CROs, and sites to support enrollment and participant dosing
• Coordinate contract manufacturing packaging, labeling, and international shipping/distribution of investigational medicinal product
• Partner with CMC, Clinical Operations, QA, and Regulatory to develop kits and label text for multiple countries/regions
• Lead or participate in IXRS development and system maintenance
• Assist with risk mitigation plans and inspection-readiness process development
• Support vendor selection and CMO qualification with Regulatory Compliance and QA
• Coordinate global material logistics and movement with the CMC team

Senior Manager, Clinical Supply

Compliance

• Provide global regulatory strategy and support as a member of multidisciplinary teams
• Manage regulatory processes from development through approval and ensure compliance with US and international regulatory requirements
• Represent Regulatory Affairs in project meetings and provide regulatory guidance to cross-functional teams
• Serve as regulatory affairs contact for external parties, including CROs and advisors, involved in global clinical trials
• Develop and implement global regulatory strategies for clinical-trial submissions and registration under applicable regulations and guidelines, including US FDA, EMA, PMDA, ICH, and ISO
• Plan, prepare, author, and/or review IND, CTA, BLA, NDA, and MAA submissions and related documentation
• Liaise with global health authorities
• Contribute to regulatory strategies that expedite development, maximize success probability, and mitigate risks
• Communicate project updates and risks to senior regulatory affairs management and organizational stakeholders
• Track regulatory commitments and deliverables and coordinate internal and external staff for timely submissions
• Coordinate and prepare responses to health-authority information requests
• Prepare meeting requests and briefing documents and coordinate teams for health-authority meetings
• Provide input into regulatory policies and procedures aligned with GxPs, guidance documents, and corporate objectives
• Monitor, analyze, and disseminate regulatory intelligence affecting development programs
• Participate in due diligence evaluations of potential in-license and partnering opportunities

Senior Director, Regulatory Affairs

Director

• Drive late-stage drug substance development, scale-up, and commercial manufacturing
• Partner with internal CMC, Regulatory, and Quality teams to design, optimize, and define robust, scalable drug substance processes
• Direct optimization and scale-up of manufacturing processes at external partners
• Apply Quality by Design (QbD) and Design of Experiments (DoE) methodologies to establish Critical Process Parameters and Critical Quality Attributes
• Lead technical transfer of drug substance processes across global CDMOs
• Lead scale-up activities and process validation campaigns in alignment with FDA, EMA, and other regulatory bodies
• Oversee commercial-scale manufacturing lines, process consistency, yield optimization, and supply robustness
• Ensure compliance with global cGMP and regulatory standards
• Establish drug substance control strategies, including impurity profiling and Proven Acceptable Ranges per ICH guidelines
• Support authoring and review of CMC sections for global regulatory submissions and responses to agency inquiries
• Collaborate with internal and external stakeholders and report to the Sr. Director of Drug Substance Development

Associate Director, Drug Substance

• Serve as lead biostatistician for Pulmovant's Phase 3 PHrontier program, including protocol development, statistical analysis plans (SAPs), and sample size/power calculations
• Partner with Clinical Development and Regulatory on trial design decisions, including endpoint selection and interim analysis strategy
• Oversee CRO/vendor biostatistics deliverables, ensuring quality and timeline adherence
• Lead statistical input for regulatory submissions, including NDA/BLA submissions and responses to health authority queries
• Collaborate with Data Management on CRF design, database structure, and data quality standards
• Present statistical results and methodology to internal leadership and external stakeholders, including DSMBs and advisory boards
• Mentor junior biostatistics staff or contractors as the function scales
• Contribute to departmental initiatives, standards, process improvements, talent development, resource planning, and inspection readiness

Director, Biostatistics

• Serve as a pharmacovigilance subject matter expert for ongoing and future clinical trials, including Phase 1 studies and the Phase 3 PHrontier study
• Oversee end-to-end case management for serious adverse events, including intake, triage, medical review coordination, regulatory reporting, and ICSR quality control
• Maintain safety mailboxes
• Monitor expedited reporting timelines and case quality metrics
• Reconcile safety data across clinical operations, CROs, and safety vendors
• Support event adjudication, Safety Review Committee activities, and IDMCs
• Review and author safety documents, including Safety Management Plans, Investigator Brochures, protocols, informed consents, and Letters of Authorization
• Support quarterly Safety Review Committee activities and maintain signal assessment logs
• Support signal detection, validation, evaluation, and escalation
• Contribute to risk management plans and safety monitoring plans
• Review aggregate safety reports, including DSURs, six-month line listings, and ad hoc safety summaries
• Maintain reporting calendars and data-lock timelines
• Track safety-related regulatory commitments and support responses to health authority queries
• Oversee PV vendor and CRO relationships, including Oracle Argus Safety, case processing, and literature surveillance
• Manage vendor governance meetings, KPIs, quality metrics, issue escalation, and CAPA follow-up
• Support PV vendor qualification and onboarding, including PVAs
• Ensure compliance with ICH-GCP, FDA, EMA, global regulations, and GVP guidance
• Author, review, and maintain PV SOPs, work instructions, and controlled documents
• Participate in audit and inspection readiness activities
• Perform quarterly QC of the electronic Trial Master File
• Represent Pharmacovigilance in cross-functional safety management and CRO meetings
• Provide PV training and guidance to internal stakeholders and investigator sites
• Mentor junior safety staff and contribute to strategic PV planning

Senior Manager, Pharmacovigilance

General

• Provide clinical and scientific input to study design, protocol concepts and development, statistical analysis plans, and reporting
• Provide medical strategic oversight and accountability for study designs, protocol development, and regulatory documents with cross-functional teams
• Lead execution and management of clinical studies, especially the Phase 3 trial, including study delivery, recruitment, site activation, data review and analysis, and reporting in compliance with GCP and regulatory standards
• Monitor the therapeutic and regulatory landscape and provide guidance for program strategy
• Collaborate with opinion leaders, Principal Investigators, internal clinicians, translational sciences, and clinical operations
• Attend and present at investigator meetings and site initiation visits
• Contribute to protocols, Clinical Study Reports, Annual Reports, safety reports, Health Authority pre-meeting packages, Investigator Brochures, and periodic clinical reports
• Prepare abstracts, manuscripts, presentations, and clinical sections of regulatory documents
• Maintain knowledge of ICH-GCP, external regulations, and procedures
• Serve as primary medical accountability and oversight source, medical lead, liaison between investigators and internal study teams, and relationship manager for key opinion leaders and Health Authorities

Clinical Development Lead, Pulmovant

IT Support

• Manage and maintain the enterprise application portfolio, including validated GxP/clinical systems and general enterprise IT applications
• Own system uptime, performance, configuration, and issue resolution across supported applications
• Lead system implementations, upgrades, integrations, and decommissions
• Coordinate computer system validation activities with Quality where required
• Maintain application governance, including change control, access management, data integrity, and system documentation
• Partner with Clinical, Regulatory, Quality, Finance, and HR teams to gather requirements and prioritize the applications roadmap
• Translate business needs into system solutions and act as a liaison between IT and business stakeholders
• Collaborate with Roivant IT on shared platforms, standards, and enterprise-wide initiatives
• Manage and mentor a team of application analysts/administrators
• Manage vendor relationships and hold vendors accountable for performance and compliance commitments
• Monitor system performance and incident trends; drive root-cause analysis and process improvements
• Identify opportunities to streamline workflows, retire redundant tools, and improve system efficiency
• Perform IT project management responsibilities, including planning, tracking, and delivery of applications initiatives