The Lead Computer System Validation Engineer will define and scale the validation strategy, operating model, and risk-based approach for the company's GxP technology portfolio. They will also lead validation lifecycle activities, mentor the CSV team, and collaborate with cross-functional partners to ensure compliance and data integrity.
The Clinical Development Leader will shape development strategy for epilepsy programs and personally lead clinical studies from design through execution. They will also interpret emerging clinical data to drive regulatory submissions and provide cross-functional leadership across various disciplines.
The Clinical Development Leader will drive lifecycle strategy for late-stage assets and lead early-phase clinical development, including first-in-human and dose-escalation studies. They will provide cross-functional leadership across clinical operations, regulatory, and translational sciences to ensure data-driven development decisions.
The Clinical Development Leader will shape development strategy and personally lead clinical trials for the movement disorders portfolio. They will interpret emerging data, drive cross-functional execution, and manage regulatory submissions and health authority interactions.
The Director of Toxicology will provide scientific and regulatory leadership for nonclinical safety activities across a portfolio of CNS disorder therapies. They are responsible for designing and overseeing toxicology studies, managing external partners, and ensuring safety strategies support clinical progression and regulatory milestones.
The Care Coordinator serves as the primary point of contact for patients and providers, managing the end-to-end patient journey from enrollment through therapy adherence. They are responsible for identifying and resolving access barriers, coordinating benefits investigations, and maintaining accurate documentation within Salesforce.
The In-House Clinical Research Associate supports study execution by managing meeting logistics, tracking action items, and ensuring protocol compliance. They are responsible for maintaining Trial Master Files and collaborating with cross-functional teams to resolve site-level issues.
Provide end-to-end Product Quality oversight for clinical and commercial programs, including drug substance, drug product, and external manufacturing partners. Lead the assessment and resolution of deviations, change controls, and CAPAs while ensuring compliance with global regulatory standards.
The TMF Operations Lead is responsible for ensuring clinical trial documentation is accurate, complete, and inspection-ready throughout the trial lifecycle. They will partner with cross-functional teams to monitor TMF health, identify risks, and drive the resolution of documentation issues.
The Regional Business Director will lead and develop a team of field professionals to drive commercial performance and execute enterprise strategy. They will partner with cross-functional teams to ensure successful product launches and maintain high standards of customer engagement.
Lead and develop a team of field sales professionals to execute commercial strategy and achieve regional performance objectives. Partner with cross-functional teams to ensure successful product launches and drive customer engagement.
The Regional Business Director will lead and develop a team of field sales professionals to drive commercial performance and execute strategy within the Southeast region. This role involves partnering with cross-functional teams to ensure successful product launches and consistent customer engagement.
The Regional Business Director will lead and develop a team of field sales professionals to execute commercial strategies and drive product performance. They will collaborate with cross-functional partners to ensure successful product launches and maintain high standards of customer engagement.
Lead, coach, and develop a team of field sales professionals to achieve commercial objectives and drive execution of strategy. Partner with cross-functional teams to ensure successful product launches and maintain high-performing regional operations.
The Director of Process Chemistry leads drug substance activities for small molecule programs, overseeing development from early phase through commercial readiness. This role involves managing CMC project teams, collaborating with external CDMO/CRO partners, and ensuring regulatory compliance for manufacturing strategies.
The Principal Scientist will lead drug substance process development activities for clinical and commercial supply within the CMC team. They are responsible for designing processes, managing external CRO/CDMO partners, and authoring regulatory submissions.
The CMLR Coordinator manages end-to-end review workflows for promotional and medical materials while ensuring compliance across cross-functional teams. This role facilitates review meetings, maintains accurate documentation, and identifies process improvements to enhance operational efficiency.
The Senior MSL will build scientific partnerships and deliver high-quality scientific exchange to support the prelaunch and launch of ulixacaltimide. They will also translate medical strategy into field execution while providing leadership and coaching to the broader MSL team.
The Medical Science Liaison will build scientific partnerships with healthcare professionals and investigators to support medical affairs objectives for ulixacaltimide. They are responsible for delivering balanced scientific exchange, gathering field insights, and ensuring compliant execution of prelaunch and launch activities.
The Payer Engagement Lead will develop and execute strategic account plans for regional commercial health plans and Medicaid organizations to ensure patient access to therapies. They will serve as a bridge between national market access strategy and regional execution while building trusted relationships with key payer stakeholders.
Design and optimize commercial capabilities, including field force KPIs, incentive compensation plans, and targeting processes. Partner with leadership to translate strategy into measurable execution frameworks and manage external data vendors to drive field performance.
Lead the enterprise payer engagement strategy for national health plans, PBMs, and GPOs to ensure patient access to CNS therapies. Serve as the principal decision-maker for pricing, contracting, and reimbursement strategies during the commercialization process.
Lead enterprise-wide financial planning, forecasting, and resource allocation to support the development of CNS disorder treatments. Partner with executive leadership and functional heads to drive strategic investment decisions and improve financial transparency through AI and automation.
Lead strategic and operational execution within Medical Affairs, focusing on resource management, vendor oversight, and cross-functional alignment. Establish operational plans and performance metrics to support therapeutic area leadership and scalable organizational growth.
Serve as the analytical lead for the commercial portfolio, overseeing analytical activities at CDMOs for small molecule drug substance and product manufacturing. Ensure compliance with regulatory commitments, maintain robust control strategies, and lead analytical investigations and lifecycle management.
Build and maintain scientific partnerships with neurology centers to deliver compliant scientific exchange on relutrigine and rare epilepsies. Gather field insights to inform medical strategy and support pre-launch clinical readiness.
Lead the development and execution of integrated product and commercialization strategies for CNS therapies. Drive cross-functional alignment across medical, regulatory, and clinical teams to ensure launch readiness and effective market positioning.
Lead analytical development and GMP testing for oligonucleotide and small molecule programs across a network of external partners. Design phase-appropriate analytical control strategies and manage the lifecycle of methods from development through commercialization.
The Senior Clinical Trial Manager is responsible for the end-to-end management of domestic and international clinical studies, from protocol concept to final study report. They oversee study budgets, regulatory submissions, and cross-functional team activities to ensure compliance with GCP guidelines and quality standards.
Build and lead the medical affairs function to support commercial launches of new products. Collaborate with cross-functional teams to implement strategies and manage ongoing development projects.
Submit your resume for consideration of future job opportunities at Praxis Precision Medicines. This submission allows the Talent Team to evaluate your qualifications for potential future openings.
