Senior Manager – CMC Project Management

🕒 Outubro 9

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

👷‍♀️ Gerente de Projetos

👻 Score fantasma 25%

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Pulmovant

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🏥 Saúde

💼 Consultoria

🍽️ Alimentos e Bebidas

Healthcare • Consulting • Food & Beverage

A Pulmovant é uma empresa comprometida em transformar a vida de pacientes com doenças pulmonares por meio do desenvolvimento de terapias inovadoras. Seu principal produto, o mosliciguat, tem como objetivo fornecer um tratamento inalável, de uso único diário, para hipertensão pulmonar, caracterizado por seu mecanismo inovador de ativação de sGC. Com um foco singular em atender às necessidades únicas de pacientes que sofrem de condições pulmonares, a Pulmovant está engajada em extensos ensaios clínicos para avançar suas opções de tratamento pioneiras.

Descrição

• Provide program and project management support for Pulmovant’s drug development programs, particularly CMC activities supporting mosliciguat and the Phase 3 PHrontier trial • Build, maintain and communicate integrated CMC timelines aligned with clinical development and regulatory milestones • Own CMC team meeting cadence, including agendas, minutes, decisions and action-item tracking through closure • Maintain the program’s single source of truth for deliverables, owners and due dates • Track risks, issues, assumptions and dependencies; escalate early and drive resolution or mitigation • Partner with CMC technical leads across drug substance, drug product and analytical development to create executable project plans • Coordinate CDMO/CMO deliverables and hold external partners accountable to agreed dates • Maintain CMC budget and spend trackers; support purchase order, invoice and accrual reconciliation • Support routing of MSAs, SOWs and change orders with Legal and Procurement • Support CMC regulatory submission timelines, including IND/IMPD amendments, Module 3 content and NDA activities • Develop and maintain timelines, dashboards and status reports for stakeholders and leadership • Facilitate collaboration across CMC, Clinical Operations, Regulatory, Quality, Supply Chain and external partners • Prepare governance and leadership review materials, including program updates and key decision points • Contribute to continuous improvement of project management processes, templates and tools • Provide broader program and project management support across Pulmovant’s pipeline as needed

🎯 Requisitos

• Bachelor’s degree in a scientific, engineering or other technical discipline, or equivalent practical experience • Senior Manager: 5+ years of relevant professional experience, including 2+ years in a project or program management capacity • Associate Director: 8+ years of relevant professional experience, including 4+ years in a project or program management capacity • Equivalent combinations of education and experience will be considered • Biopharmaceutical CMC experience is strongly preferred; project management experience in another technical or regulated environment may be considered • Familiarity with drug substance and drug product development, analytical development, GMP manufacturing, and working through CDMOs/CMOs, or a credible plan to rapidly develop this familiarity • Experience managing projects beyond CMC, including clinical operations, regulatory affairs or general program management • Demonstrated experience building and maintaining integrated timelines in Smartsheet, Microsoft Project, Office Timeline, Planisware or equivalent • Experience supporting programs through Phase 1–3 clinical development is valued • Exceptional organization and attention to detail • Strong facilitation and disciplined follow-through • Ability to influence and create accountability without direct authority • Clear and concise written and verbal communication • Comfort with ambiguity and shifting priorities • Scientific and technical curiosity • Sound judgment and discretion; ability to operate independently in a lean, fast-paced clinical-stage biotech environment • Strong working proficiency with Excel, PowerPoint and SharePoint/Teams • Fluency or fast aptitude with timeline and dashboard tools • Flexibility to support project management outside CMC

🏖️ Benefícios

• Periodic travel associated with the role • Equal employment opportunities and protection from discrimination and harassment