Pulmovant

Clinical Operations

• Responsible for clinical operations strategy, initiation, and execution of clinical trials, including (but not limited to) CRO/vendor selection, contracts & budgets, CRO/vendor oversight, and proactive risk management to ensure the quality conduct of trials with a high level of quality and data integrity
• Responsible for the successful planning and execution of Phase 2 and 3 trials
• Proactively builds and strengthens site and Investigator relationships and actively cultivates site engagement
• Work cross functionally to drive strategy, oversee the implementation of all clinical programs, and manage the integrated development plans to deliver against company goals
• Proactively identify potential risks and develop and implement actions and plans to avoid or mitigate program risks and make appropriate plan to balance risks, deliverables, and costs
• Lead and supervise all aspects of study progress from concept to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with regulatory guidelines; heavy emphasis on late-stage development experience
• Develops and optimizes critical SOPs needed for program success, inspection readiness and compliance
• Oversee identification, qualification, and selection of CROs and vendors needed to conduct clinical trials including approval of Master Services Agreements and Task Orders with CRO
• Liaise with KOLs, Investigators, and clinical site staff to ensure optimal Sponsor-Site relationships
• Provide scientific/clinical expertise in the design and interpretation of clinical studies
• Ensure effective project or program communications and updates to internal and external stakeholders through meetings, presentations, and other methods
• Provide direct line management and training/mentoring of Clinical Operations team members
• Ensure clinical operation team are trained in regulatory inspection process and develop a pro-active approach for inspection readiness
• Align skills and resources needed for program success; work closely with internal and external stakeholders to leverage and optimize resources
• Create and oversee clinical program budget(s) and long-range clinical planning/forecasting activities
• Ensure there is proper oversight of identified safety concerns and/or adverse events; develop and implement corrective actions accordingly, and participate in internal/external study related audits, as needed
• Contribute as required to the authoring of key regulatory documents, study protocols, investigator’s brochures, IND reports, study postings, ensuring document and operating standards are established and maintained
• Participate in business development and process improvement/quality initiatives, as needed

Head of Clinical Operations

Compliance

• Able and willing to do hands on document formatting and regulatory publishing.
• Responsible for all documents and submissions to be error free from a regulatory validation standpoint with submissions made on time to meet any internal or external requirements.
• Responsible and accountable for implementing SOPs and work processes for documentation, publishing, submissions and archiving.
• Works with regulatory strategists and CMC strategists and project team members to execute the regulatory strategy.

Senior Manager, Regulatory Documentation and Operations

Director

• Provide planning and execution of Clinical Supply Chain activities to support Pulmovant clinical studies globally.
• Coordinate operations including clinical packaging, labeling, and distribution.
• Actively manage all inventory, logistics and forecasting for the clinical study.
• Be the subject matter expert related to clinical drug supply during all phases of the clinical trial.
• Support activities leading to the implementation of global clinical inventory management, supply planning and distribution systems consistent with meeting cGMP, clinical development programs, corporate objectives.
• Responsible for vendor management including performance metrics and contractual agreements.
• Directly oversee contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on time delivery to support clinical trials.
• Manage, coach and mentor Clinical Supply Managers.
• Develop best in class clinical supply area.

Associate Director, Clinical Supply

• Evaluate the current information systems and infrastructure landscape inherited from Roivant; identify strengths, weaknesses, and modernization opportunities.
• Develop multi-year IS and infrastructure roadmaps that align R&D and enterprise technology capabilities with Pulmovant’s evolving scientific and business objectives.
• Define and execute the R&D IS strategy as Pulmovant transitions away from Roivant, ensuring continuity, compliance, and scalability.
• Advise executive leadership on modernization, emerging technology trends, AI/automation opportunities, and long-term digital strategy.
• Own the lifecycle of core R&D systems (e.g., SDMS, CTMS, eTMF, QMS, PV/Safety, Veeva Vault, SAS/biostats platforms).
• Lead feasibility studies, vendor evaluations, and cost-benefit analyses for all R&D IS investments.
• Oversee the design and delivery of system integrations supporting data flow, analytics, and operational excellence.
• Drive adoption of AI, automation, and analytics to improve R&D efficiency, quality, and insight generation.
• Serve as the primary liaison between Pulmovant and Roivant IT during the transition period, ensuring coordinated delivery of infrastructure and enterprise services.
• Coordinate with Roivant end-user IT support, including help desk service, escalation management, and service-level expectations.
• Oversee and coordinate employee onboarding/offboarding workflows, including account provisioning, access management, equipment requests, and IT orientation.
• Ensure timely and efficient management of endpoint devices, licenses, collaboration tools, identity/access management, and enterprise applications used by R&D.
• Work with Roivant IT to ensure Pulmovant’s infrastructure (network, security, collaboration platforms, identity management) meets operational, compliance, and scalability needs.
• Establish and enhance processes for IT demand management, resource allocation, project delivery, vendor management, and service operations.
• Partner with Quality to ensure strong CSV/CSA practices and maintain full GxP compliance across the R&D IS ecosystem.
• Ensure compliance with 21 CFR Part 11, GxP, GDPR/HIPAA, cybersecurity standards, and Pulmovant’s security policies.
• Advise on IT policies, SOPs, system management standards, and risk mitigation strategies.
• Drive continuous improvement of operational reliability, system performance, and user experience.
• Lead and grow a team of IS professionals, contractors, and managed service providers.
• Manage multi-vendor relationships, ensuring high-quality service delivery, clear accountability, and value realization.
• Communicate system strategies, technology needs, and project updates clearly to executive leadership and cross-functional partners.

Director, Head of IT

• Serve as the Drug Product Technical Lead for the inhalation dosage form, accountable for product performance, manufacturability, and lifecycle management.
• Lead Phase 3 process characterization, validation, and registration batch execution at CDMOs.
• Provide scientific oversight of formulation development, device compatibility, and container–closure system.
• Partner with other functional area leads to ensure successful method validation, product specifications, and stability studies to support regulatory filings.
• Partner with Quality, Regulatory, and Supply Chain to ensure GMP compliance and pre-approval inspection (PAI) readiness.
• Represent drug product in CMC team meetings, regulatory submissions (Module 3), and health authority interactions.
• Manage technology transfer when needed, manufacturing documentation, and process validation protocols/reports.
• Collaborate closely with other functional areas (drug substance, analytical development, and QA) to ensure a robust control strategy.
• Provide technical guidance and mentoring to junior staff or matrixed contributors as needed.

Head of Clinical Operations

Senior Manager, Regulatory Documentation and Operations

Associate Director, Clinical Supply

Director, Head of IT

Director of Drug Product Development