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Praxis Precision Medicines
Praxis Precision Medicines
8 open remote positions
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. The company is a lean, agile team guided by core values of Trust, Ownership, Curiosity, and Results, fostering a collaborative and high-impact culture.
Salary Distribution
8 of 8 jobs
Benefits Overview
5 of 8 jobs
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Open Positions
Lead negotiation and execution of complex contracts including clinical trial agreements, CRO agreements, and strategic partnerships. Define and improve the end-to-end contract lifecycle, setting standards and operating models for scalability. Provide practical legal guidance and leverage AI tools to enhance speed and quality of legal operations.
Contract Negotiation
Legal Compliance
AI Tools
Vendor Management
Own regulatory review and approval of promotional materials across HCP, DTC, digital, and social channels, ensuring compliance with FDA regulations. Partner with Commercial, Medical Affairs, and Legal to shape campaigns and claims, providing clear guidance to reduce approval delays. Lead FDA promotional submissions, monitor regulatory trends, and build scalable processes to support product launches.
Regulatory Affairs
FDA Regulations
Cross-functional Collaboration
Execute analytical strategies for commercial products, ensuring compliance and method lifecycle management. Lead method transfer, validation, and investigations at CDMOs, supporting regulatory submissions. Serve as analytical SME, partnering cross-functionally to ensure quality and supply continuity.
GMP
Regulatory Compliance
Data Integrity
Lead and scale the Computer System Validation capability across IT, defining validation strategy, operating model, and risk-based approach while building the CSV team. Author, review, and execute validation lifecycle deliverables including validation plans, requirements, risk assessments, and test protocols. Collaborate with Quality, IT, business owners, and vendors to translate compliance needs into practical, scalable validation strategies.
GxP
Data Integrity
Drive lifecycle strategy to expand the impact of late-stage and marketed assets across new indications and formulations. Lead early clinical development including first-in-human studies and data-driven dose selection. Provide pipeline-wide clinical leadership and represent Praxis with health authorities and partners.
Clinical Development
Regulatory Strategy
Data Interpretation
Cross-functional Leadership
Provide scientific, strategic, and regulatory leadership for nonclinical safety activities across Praxis’s portfolio of CNS therapies. Own toxicology strategy for assigned programs from discovery through IND-enabling development and toward NDA/MAA. Lead regulatory toxicology activities, including contributions to INDs, CTAs, IBs, DSURs, and responses to health authority questions.
Regulatory Affairs
CRO Management
Support study execution by managing meeting logistics, documenting decisions, and tracking action items. Partner with Clinical Operations and site monitors to ensure protocol compliance and quality standards. Responsible for filing site-level documents into Trial Master Files and assisting with regulatory submissions.
Clinical Research
GCP
Regulatory Submissions
Microsoft Office
Provide end-to-end Product Quality oversight for clinical and commercial programs, including drug substance, drug product, packaging, and labeling. Lead resolution of deviations, OOS/OOT, change controls, CAPAs, and product quality complaints with risk-based decisions. Represent Product Quality on CMC and external partner teams to support development, regulatory submissions, and commercialization.
GMP
Regulatory Compliance
Product Lifecycle Management