Praxis

Director

• Lead and manage outsourced manufacturing operations supporting Praxis’s clinical and future commercial programs.
• Oversee Contract Development and Manufacturing Organizations (CDMOs) for drug substance (API) and drug product manufacturing.
• Ensure high-quality, compliant, and timely supply of clinical materials.
• Serve as the primary operational interface between Praxis and external manufacturing partners.
• Oversee technology transfer, process scale-up, validation, and clinical supply readiness.
• Establish and maintain robust Quality and Technical Agreements with manufacturing partners.
• Manage and optimize the end-to-end supply chain process.
• Lead supplier qualification, monitoring, and performance evaluations.
• Negotiate contracts and pricing agreements with suppliers and CMOs to achieve cost-effective outcomes.

Director, External Manufacturing – CMC

Data Scientist

• Lead the design, development, and validation of R/Python code to automate generation of analytical datasets and TLFs within a metadata-driven pipeline.
• Translate SAPs and metadata specifications (YAML/CSV) into executable and reproducible code.
• Build and validate R packages and data science tools supporting both exploratory and confirmatory analyses.
• Implement and validate statistical models (e.g., MMRM, ANCOVA, logistic regression).
• Collaborate with IT to integrate data science and statistical programming workflows within Databricks and CI/CD pipelines.
• Collaborate across programming, biostatistics, and data standards functions to ensure dataset definitions, derivations, and metadata align with controlled standards.
• Conduct peer code reviews, unit testing, and automated validation.
• Mentor and guide team members in best practices for programming, validation, and automation.

Associate Director, Statistical Data Scientist

Engineer

• Ability to understand varied formulation processes and transfer drug product processes for industrialized execution
• Efficient use of technologies and applications to gather, analyze and archive large data packages
• Review relevant documentation from CMOs and lab partners
• Work alongside Quality Assurance to ensure regulations and standards are followed
• Adhere to industry guidelines, standards and laws including being well-versed in cGMPs
• Travel required - PIP at CMOs (US and worldwide)

Senior Manager, Process Engineer – Drug Product

• Validate processes related to the primary and secondary packaging of drug products
• Oversee future commercial production to ensure appropriate supply levels
• Lead day-to-day communications with Contract Manufacturing Organizations (CMOs)
• Work alongside Quality Assurance to ensure regulations and standards are followed
• Review relevant documentation from CMOs and lab partners

Process Engineer – Packaging

• Design and optimize robust oral solid dosage formulations for clinical and commercial development.
• Lead tech transfer activities from development to external manufacturing, ensuring seamless scale-up and validation.
• Author and review key technical documentation including batch records, master manufacturing records, and process validation protocols.
• Investigate and resolve deviations and batch failures in collaboration with QA, Regulatory, and CDMO partners.
• Serve as the technical point of contact for CDMO selection, oversight, and performance management.
• Drive process improvements using QbD and risk-based approaches to meet quality, regulatory, and timeline expectations.
• Collaborate with cross-functional teams to ensure end-to-end alignment.

Engineer/Scientist, Drug Product Process Development – Manufacturing

Sales

• Develop and implement a comprehensive sales strategy aligned with Praxis’ commercial objectives.
• Build, recruit, and lead high-performing sales teams to support product launch and ongoing commercialization efforts.
• Establish sales targets, KPIs, and performance metrics to ensure accountability and drive results.
• Collaborate with marketing and analytics, medical affairs, market access, and other functions to optimize launch readiness and execution.
• Analyze market trends, customer insights, and competitive landscape to identify growth opportunities.

Head of Sales

• Partner with cross-functional stakeholders to plan and execute BI&A research.
• Lead research projects end-to-end, from study design and vendor management to analysis.
• Track competitors, products, and technology platforms; identify emerging trends.
• Translate complex findings into clear, actionable insights and communicate effectively.
• Maintain up-to-date competitive landscapes and track competitors, products, and technology platforms.
• Champion a culture of evidence-based decision making.

Associate Director, Business Insights, Analytics

Research Analyst

• Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, ICH-GCP, and regulatory requirements.
• Verify source data and ensure accuracy, completeness, and consistency with case report forms (CRFs) and study databases.
• Review monitoring reports and follow-up letters to ensure timely resolution of issues.
• Assist CTMs in site activation activities and provide ongoing site management support.
• Collaborate with cross-functional teams (Data Management, Medical, Regulatory, Quality) to maintain high-quality trial conduct.
• Identify and escalate protocol deviations, data integrity issues, and safety concerns.
• Maintain study files and documentation, ensuring compliance with SOPs and trial master file (TMF) requirements.
• Support investigators and site staff with training and guidance on study procedures.
• Perform direct site management, monitoring visits, and close collaboration with site staff and cross-functional teams to support the successful execution of studies.

Clinical Research Associate

Operations

• Operational and strategic support: partner closely with commercial leadership to set priorities, manage timelines, and ensure follow-through on key initiatives.
• Oversee and facilitate day-to-day operational logistics, including meeting preparation, agenda setting, follow-up, and tracking of deliverables.
• Coordinate and manage strategic planning processes, quarterly reviews, and budget alignment.
• Commercial buildout: support recruitment efforts with the People Team to define roles, onboard new team members, and accelerate team integration.
• Identify, evaluate, and implement tools, systems, and processes to enable commercial readiness and execution.
• Drive initiatives to develop internal capabilities, ensure operational excellence, and contribute to organizational design and scaling of the commercial function.
• Launch readiness: lead or contribute to high-priority cross-functional projects, process optimization, and governance structures.
• Drive cross-functional launch readiness activities, ensuring alignment across market access, supply chain, field operations, and external stakeholder engagement; develop and manage launch frameworks, including milestones, risk tracking, and scenario planning.
• Cross-functional liaison: serve as the primary connection point between Commercial Operations and G&A functions (Finance, HR, Legal, IT, etc.), anticipate cross-functional needs, and proactively address organizational bottlenecks.
• Facilitate effective communication, alignment, and collaboration across departments; may manage external partners and vendors as commercial infrastructure evolves.

Commercial Strategy and Operations

• Collaborate with and support stakeholders within Analytical Development, Regulatory CMC, and Quality Assurance to ensure alignment on stability strategies and compliance with ICH guidelines.
• Ensure that analytical documentation (protocols, reports, change controls, etc.) are added contemporaneously to Praxis’ document management system.
• Contribute to regulatory filings (e.g., IND, IMPD, NDA) by preparing stability summaries and providing supporting information.
• Collaborate with other functions of Praxis CMC to execute the technical and business practices of the team.
• Lead the establishment, execution, and management of stability studies internally and at CDMO partners for drug substance and drug products across all development phases.
• Monitor CDMO performance with respect to agreed timelines for providing stability protocols and reports and establish metrics as needed.
• Review raw data, calculations, stability protocols, and stability summary reports in direct support of the Analytical Development Project Leads.
• Perform trend analysis of stability data to be used in shelf-life assessment.
• Ensure timely data review to support OOT/OOS investigations and implementation of corrective actions related to stability studies.
• Monitor execution of reference standard lifecycle management, including qualification, requalification, inventory, and expiry tracking in coordination with external testing sites.

Manager/Senior Manager, Analytical Operations

• Ensure clinical trial documentation is accurate, complete, and inspection-ready
• Serve as TMF subject matter expert and trusted partner to study teams
• Oversee eTMF set-up, maintenance, and regular quality reviews
• Monitor TMF health, milestones, and deliver metrics and insights to teams
• Guide and support trial teams to stay compliant with document lists and timelines
• Identify and resolve TMF issues and escalate when needed
• Contribute to SOPs, processes, and industry best practices
• Ensure access and compliance with global TMF standards and regulations