Praxis

Research Scientist

• Responsible for translating the processes and products for Praxis’ clinical and commercial pipeline from the laboratory to the manufacturing environment.
• Use knowledge of analytical method development, qualification, validation, and troubleshooting to deliver to Analytical Team.
• Strong collaboration with Drug Substance/Drug Product scientists, engineers, Quality and manufacturing to ensure efficiency and control.
• Lead contributing to ensuring the analytical function is agile and at the forefront in the industry.
• Deliver to product teams within CMC to realize Praxis’ pipeline of innovative medicines for neurological disease.
• Involved in all analytical deliverables with CMC program while acting as Analytical lead, including management and execution of analytical testing.

Principal Scientist, Analytical Development

Manager

• Involved in supporting analytical deliverables of the CMC programs while working in conjunction with CMC team members.
• Management of analytical testing in our external network, especially as it relates to GMP drug substances and drug products.
• Ensuring that analytical documentation (protocols, reports, methods, COAs, change controls, etc.) are added contemporaneously to Praxis’ document management system.
• Oversight and coordination of CMC stability and reference standard programs.
• Direct monitoring of our external network providers that execute Analytical Development activities to ensure deliverables and continuously improve efficiency.
• Supporting the design and development of phase-appropriate quality control strategies, specifications, and stability studies for drug substance and drug product.
• Contribute to the overall CMC team in terms of execution.
• Collaborate with other functions of Praxis CMC to establish the technical and business practices of the team.

Senior Manager, Analytical Development

Director

• Own and drive the global API strategy across Praxis’ portfolio.
• Lead the design, development, and industrialization of robust, phase-appropriate drug substance processes.
• Act as a thought leader and decision-maker in CMC governance forums.
• Build and lead a high-performing, multidisciplinary ecosystem of internal talent and external partners.
• Define and execute vendor strategy, including partner selection, technical oversight, contract negotiation, and performance governance.
• Ensure seamless integration with Analytical, Formulations, Regulatory, Quality, and Clinical Supply.

Executive Director – Process Chemistry

Compliance

• Develop and lead global Regulatory CMC strategies for investigational and commercial small molecule and ASO products, aligned with development, manufacturing, and commercialization objectives.
• Serve as the Regulatory CMC subject matter expert, providing strategic guidance on regulatory risks, timelines, and mitigation plans across the product lifecycle.
• Ensure strong cross-functional partnership and alignment with Quality, Analytical, Development, Supply Chain and Commercial Manufacturing teams to support integrated CMC planning and execution.
• Author and oversee preparation, review, and submission of CMC sections for INDs, IMPDs, NDAs, and post-approval supplements, ensuring consistency, quality, and regulatory compliance.
• Lead and support CMC-related interactions with global health authorities (e.g., FDA, EMA), including meeting strategy, briefing materials, and responses to regulatory inquiries.
• Provide regulatory oversight for clinical and commercial manufacturing, including process validation, control strategies, stability programs, and supply continuity.
• Lead CMC regulatory strategies for post-approval changes, comparability assessments, technology transfers, and manufacturing site changes.
• Build and manage internal Regulatory CMC capabilities and oversee external consultants, CMOs, and regulatory vendors, contributing to scalable processes and governance.

Senior Director, CMC Regulatory Affairs

• Support development and execution of global CMC regulatory strategies for investigational and commercial small molecule and ASO programs, under the direction of the Senior Director
• Author, compile, and review CMC sections of regulatory submissions, including INDs, IMPDs, NDAs, BLAs, amendments, and post-approval supplements
• Coordinate CMC content development with Quality, Analytical, Development, and Commercial Manufacturing teams to ensure accuracy, alignment, and readiness for submission
• Support and participate in health authority interactions, including preparation of briefing documents, responses to information requests, and meeting logistics
• Maintain regulatory compliance for CMC activities supporting clinical supply, commercial manufacturing, and ongoing product supply, including stability updates and annual reports
• Assist with post-approval change management, including comparability assessments, manufacturing changes, and technology transfers
• Manage and coordinate external consultants, CMOs, CROs, and regulatory vendors supporting CMC regulatory activities

Senior Manager – CMC Regulatory Affairs

• Define and drive a strong GCP quality culture across clinical programs.
• Oversee clinical quality systems and metrics, anticipate and escalate risk before it becomes an issue.
• Work with Clinical Operations, Regulatory, Safety, and other partners to keep trials inspection-ready.
• Support and develop Clinical Quality team members guiding inspection readiness, deviations, investigations, audits, and CAPAs.
• Shape an integrated, proactive clinical quality strategy that scales with the pipeline.
• Develop and report key quality metrics across all clinical programs and trials.
• Assess current-state quality across programs, processes, and trials.
• Identify trends, risks, and lead process and system improvements.
• Ensure compliance with GCP, ICH-GCP, FDA, EMA, PMDA, and applicable regulations.
• Author standard operating procedures and related documents.
• Monitor regulatory changes and assess impact to programs.
• Provide guidance and mentorship to clinical quality staff assigned to clinical programs and supporting study teams.

Director, Clinical Quality – Program and Process Quality

Clinical Operations

• Lead the study team to design, develop, execute and deliver clinical studies.
• Serve as a Clinical Operations representative at the program level and liaise cross-functionally.
• Monitor progress of clinical study activities and report on them.
• Lead the evaluation, selection, and oversight of CROs and other vendors.
• Provides strategic and tactical guidance in risk management.
• Contribute to writing and review of clinical documents on assigned program.
• Liaise with clinical site staff and investigators to ensure optimal Sponsor-site relationships.
• Direct initiatives to identify and implement best practices and continuous improvement plans.

Clinical Operations Lead

Operations

• Lead the development and execution of quality oversight strategies across commercial and clinical supply chains.
• Ensure GMP compliance in support of global product distribution.
• Drive operational excellence and build cross-functional partnerships.
• Oversee quality operations related to 3PL contract service providers.
• Lead the development, review, and approval of key product and process documents.
• Own quality review and approval of change controls, deviations, investigations, temperature excursions, CAPA, and Product Quality Complaints.
• Represent Quality in cross-functional strategic discussions and governance forums.

Associate Director, Quality Operations – Commercial & Stability, CMC

Events

• Own and evolve Praxis’ congress strategy in partnership with internal stakeholders by defining key objectives and creating solid action plans for external events.
• Project manage end-to-end execution of Praxis’s presence at major medical and scientific congresses (e.g., AAN, AES, EAN) as well as country-level and regional meetings in the US and abroad.
• Coordinate internal planning timelines, budget tracking, and vendor management (booth design, A/V, shipping/logistics).
• Ensure seamless onsite execution: staff scheduling, materials delivery, real-time troubleshooting, and compliance with congress rules Support speaker engagement logistics including travel, honoraria, and contracts.
• Track performance and feedback from each congress to continuously improve execution.
• Maintain up-to-date congress calendar and provide ongoing reporting to stakeholders.

Congress & Events Lead

• Develop standard operating procedures, work instructions, forms, and templates to ensure a fit-for-purpose clinical auditing and inspection management program to ensure compliance with Good Clinical Practice(GCP)/Good Pharmacovigilance Practice(GPvP)/Good Clinical Laboratory Practice (GpLP).
• Develop dynamic, risk-based audit strategy and plan for critical sponsor processes and systems, clinical trials, investigator sites, and vendors/contract service providers (CSPs).
• Plan, lead, conduct, document, report, and follow-up on clinical quality audits according to regional compliance regulations, guidance, contracts, and quality agreements.
• Ensure appropriate escalation to responsible management for critical audit findings and support.
• Provide education and guidance on audit processes and activities.
• Manage audit reports, findings, and CAPAs in Veeva Quality Management System (QMS) and review and approve finding responses and actions in system.
• Develop and monitor audit finding response and CAPA timeliness performance metrics and present trends and improvement plans to senior management.
• Partner with departments across organizations to ensure consistent implementation and execution of audit program.
• Work independently with respect to decision making and problem solving.