Pulmovant

Manager/Senior Manager, Statistical Programming, Pulmovant Pulmovant

Remote — United States

Bachelor's degree in Statistics, Mathematics, Computer Science, or a related field; Master's degree preferred5–7+ years of statistical programming experience in pharma, biotech, or a CRO (Manager: 5+ years; Senior Manager: 7+ years)Advanced proficiency in SAS (Base, Macro, STAT, GRAPH) requiredThorough knowledge of CDISC standards (SDTM, ADaM, CDASH) and regulatory submission requirements (FDA eCTD, define.xml, Reviewer's Guides)Proven experience as lead programmer on at least one late-phase (Phase 2b/3) clinical study and/or regulatory submissionStrong understanding of GCP, ICH E3/E9 guidelines, and FDA/EMA data submission expectations

Associate Director, Drug Substance, Pulmovant Pulmovant

Remote — United States

Ph.D. or M.S. in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a closely related discipline8+ years of progressive experience in drug substance development and manufacturing within the pharmaceutical industry, focusing on late-stage development and commercializationStrong background in managing CDMO relationships and outsourcing strategiesDemonstrated experience in process development, scale-up, and technical transferKnowledge of global regulatory requirements and cGMP complianceExcellent project management, organizational, and leadership skillsAbility to work in a fast-paced, cross-functional environment and influence internal and external stakeholdersIn-depth knowledge of material sciences and solid-state characterization, including ssNMR, XRPD, and advanced spectroscopic techniquesExperience with inhaled/inhalation products is a plus

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