Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Praxis is preparing for its first commercial launch. The Director, PSP Operations will partner closely with the Head of Patient Services to operationalize the Relutrigine Patient Support Program and stand up the internal HUB ahead of approval.

This is a builder-operator role. You will translate strategy into execution, standing up workflows, pressure-testing processes, and ensuring systems, teams, and partners are ready for launch. You will serve as the operational integrator across HUB, field teams, and partners to ensure every patient touchpoint is seamless, compliant, and reliable. Experience in rare disease and internal HUBs is required for this role.

You will own day-to-day HUB execution, including case management operations, workflow integrity, and performance management. This includes building and refining intake pathways and process flows, SOPs, training, and quality controls of the case management team to enable consistent, high-quality execution.  Previous experience managing a case manager team is required.

A critical part of this role is applying strong technology judgment, leveraging CRM platforms, and tools to improve efficiency, data quality, and patient experience in practical, compliant ways to enable an exceptional HUB experience. You are curious and proactive, comfortable testing new approaches while maintaining a high bar for patient safety and compliance and know when to pilot versus scale proven solutions.

Primary Responsibilities

• Operationalize the HUB: Stand-up core PSP operations including intake pathways, process flows, SOPs, training materials, call guides, FAQs, and quality controls
• Support Salesforce CRM build and systems integrations: Partner with vendor partners and technology teams to support CRM configuration, data flows, and end-to-end systems integrations; ensure tools are connected, functional, and aligned to HUB workflows; willing to explore and implement AI-powered features, automation capabilities, and emerging integrations to drive operational efficiency and unlock new ways of working
• Build, manage and lead day-to-day operations: Recruit, onboard, develop and performance manage a high-performing patient support team, establishing clear roles, accountability structures, and a culture of excellence ahead of launch
• Establish and manage performance standards: Define SLAs, monitor performance, conduct root-cause analysis, and hold teams and vendors accountable
• Partnership & Collaboration: Ensure clear, consistent handoffs across HUB, field teams, MSLs, market access, and vendor partners; serve as the primary operational liaison across commercial, medical, legal, and market access functions, influencing without authority to drive alignment
• Own the patient and HCP experience: Take end-to-end ownership of the patient and HCP journey, ensuring every touchpoint is seamless, compliant, and centered on access and support outcomes
• Manage escalations: Own complex case escalations, patient safety events, and adverse event reporting pathways, ensuring timely resolution and appropriate documentation
• Vendor oversight and management: Formally manage vendor performance, contract adherence, and relationships; where applicable, lead or support HUB vendor evaluation and onboarding
• Embed compliance into execution: Ensure HIPAA adherence, audit readiness, and appropriate controls across all workflows in partnership with Legal and Compliance
• Drive data integrity and visibility: Define reporting needs and ensure accurate case documentation and data capture to enable visibility into performance, access barriers, and risk
• Stakeholder reporting: Provide regular updates to senior leadership on program performance, KPIs, risks, and operational health
• Own budget and resources: Manage operational budget, vendor contracts, and cost tracking to ensure fiscal accountability and resource alignment
• Own launch readiness: Identify operational gaps early, prioritize fixes, and ensure the program is fully functional and resilient for launch, recognizing this is a full build with a 3-month runway
• Translate strategy into execution: Implement program design, pressure-test workflows, and ensure processes perform reliably in real-world conditions on day one

Qualifications and Key Success Factors

• Rare disease experience is required; candidates without direct rare disease PSP or HUB experience will not be considered
• Direct experience managing internal HUB operations is required; this is not a role for candidates whose experience is limited to oversight of fully outsourced models
• 7+ years of progressive experience in patient services, PSP operations, or HUB leadership supporting patients and HCPs within the rare disease environment
• Proven experience building or operationalizing PSP infrastructure in pre-launch or early commercial settings; direct experience launching a program from inception, not just managing an existing one
• Experience with small patient populations, named patient programs, or rare disease registry requirements strongly preferred
• Strong ability to translate strategy into execution with a focus on reliability, scalability, and real-world performance
• Demonstrated cross-functional leadership and ability to influence without authority across commercial, medical, legal, and market access teams
• Proven change management skills with the ability to build, pivot, and adapt quickly in a fast-moving, pre-launch environment
• Hands-on experience configuring or administering a Salesforce CRM platform within a patient services or HUB environment strongly preferred
• Demonstrated curiosity and willingness to explore AI-driven tools, workflow automation, and innovative technology integrations — bringing a solutions-oriented, outside-the-box mindset to operational challenges

Additional Information

• This role requires periodic travel for vendor site visits and cross-functional collaboration
• This is a high-impact build role with a 3-month launch timeline — ideal candidates are energized by ambiguity, move with urgency, and thrive in fast-paced, high-stakes environments
• Competitive compensation commensurate with rare disease director-level expertise; salary range to be included
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job-related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Praxis Medicines is seeking a Commercial FP&A leader to serve as a strategic finance partner to our Commercial organization as we prepare for launch and scale toward a multi-billion-dollar revenue organization. This role will support near-term launch readiness while also building the financial capabilities, discipline and insights required to operate at commercial scale over time.

This role sits within Finance but works in close, real-time partnership with Commercial, CMC and other cross-functional teams. The successful candidate will be deeply embedded in ongoing commercial workstreams, enabling forward-looking decision-making through continuous engagement rather than periodic reporting.

Primary Responsibilities

• Act as the primary FP&A partner to Commercial leadership, supporting brand strategy, launch planning and revenue forecasting from pre-launch through scale.
• Perform revenue modeling, scenario and sensitivity analyses and key commercial assumptions as the business grows to multi-billion-dollar revenue levels.
• Partner closely with CMC and Supply Chain teams on inventory assumptions, demand planning and working capital considerations.
• Collaborate cross-functionally on pricing, gross-to-net, market access and demand dynamics.
• Lead Commercial and CMC input into budgets, ongoing forecasts and long-range plans.
• Evaluate investment decisions through ROI analysis and financial modeling to support prioritization and resource allocation.
• Develop executive-ready materials that clearly communicate risks, opportunities and trade-offs.
• Continuously improves forecasting tools, processes and analytical rigor to support a scaling commercial organization.
  
  

Qualifications and Key Success Factors

• 12–15+ years of experience in FP&A or strategic finance, with strong commercial exposure
• Biopharma experience required, including experience supporting a commercial-stage company
• Experience supporting product launch and operating in a scaled commercial environment preferred
• Advanced financial modeling and analytical skills
• Proven ability to influence and partner with senior stakeholders across Finance, Commercial and CMC
• Strong business judgment and executive communication skills
• Comfortable operating in a fast-paced, evolving environment with ambiguity
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

About the Role 

We’re looking for a dedicated and passionate TMF Operations Lead to ensure our clinical trial documentation is accurate, complete, and always inspection-ready. You’ll be the go-to TMF expert for our study teams and play a key role in driving quality, compliance, and innovation across trials. 

Primary Responsibilities

• Be the 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, escalating when needed.
• Contribute to SOPs, processes, and industry best practices.
• Ensure access and compliance with global TMF standards and regulations. 

Qualifications and Key Success Factors

• 5+ years of TMF management experience and a bachelor’s degree.
• Deep knowledge of ICH/GCP, FDA, and international TMF requirements.
• Strong experience with eTMF systems (Veeva preferred).
• Expert understanding of TMF structure, content, and processes.
• Critical thinker who can solve problems quickly and effectively.
• Organized and detail oriented
• Great communicator and team player 

Praxis Values 

• Patients First
• Scientific Rigor
• Integrity
• Collaboration
• Urgency with Purpose
• Accountability 

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job-related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

Position Summary 

Praxis’s Regulatory team is seeking an astute Senior Regulatory Submissions Manager who will oversee the operational aspects of all submissions to U.S. and international Regulatory Agencies. This person will manage the planning, tracking, coordinating, compiling, QC, submitting, and archiving of submissions. They will ensure that submissions are of the highest quality and delivered on-time to meet U.S. and international regulatory requirements and company goals. 

Primary Responsibilities

• Ensure continuous, compliant and timely regulatory submissions
• Create and manage submission content plans in conjunction with Regulatory Affairs strategy and CMC leads, cross-functional colleagues, and global vendors, from initiation through to approval and dispatch, for all Regulatory submissions (IND, IMPD, NDA, MAA, Agency Responses, others)
• Publish, validate, and transmit eCTD submissions to the gateway
• Track regulatory commitments for assigned products
• Schedule and coordinate, with contributing departments, the development of submission deliverables
• Communicate directly with functional authors to obtain submission documents in a timely manner
• Manage the publication and submission of regulatory documents in electronic common technical document (eCTD) format, and/or paper submissions, when required
• Oversee the writing, review, implementation, and continuous improvement of standards, templates, and procedures related to the publishing, review, QC, transmittal, and archiving of paper and electronic regulatory documentation
• Develop and maintain best practices, consistent with evolving FDA and international guidelines for electronic submissions
• Serve as a contact for the maintenance of electronic document management systems and publishing tool used to support regulatory submissions, identifying system issues, reaching out to the appropriate resources and stakeholders, and coming up with solutions 

 Education and Professional Experience 

• Minimum of BS or BA in a scientific or relevant technical discipline preferred
• Experience of 7+ years pharmaceutical or biotech industry, with basic regulatory operations experience managing the creation and submission of an IND/NDA/BLA
• Experience with Microsoft Word, Adobe Acrobat, Smartsheet, electronic publishing software, and electronic document management systems required; experience with Veeva RIM, Submissions, and Archive preferred
• Experience with Veeva Publishing preferred
• Current knowledge of, and experience with eCTD, including expertise with submission publishing tools (eCTD building tools); experience with publishing, validating, and submitting in full eCTD format; knowledge of publishing best practices
• Proven ability to function in a biotech start-up, fast-paced, innovative, dynamic environment while remaining flexible, proactive, and resourceful
• Ability to adhere to strict project timelines and budgets, and to advise teams and management of impacts and changes in project timelines 

Other Essentials and Key Success Factors  

• Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile, team-based environment. 
• Ability to think critically with a keen sense of urgency and demonstrated problem solving abilities. 
• Self-motivated, able to influence and guide the work of team members and contribute to a productive and collaborative team environment.
• Highly organized and detail-oriented with a passion to deliver quality results. 
• Strong verbal and written communication skills.
• Comfortable with independently making decisions and communicating in a direct fashion.  
• Approaches his/her work with professionalism, integrity and personal confidence. 

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job-related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Praxis Precision Medicines is building a strong pipeline of Software Engineering talent to support the continued evolution of our eDiary and clinical data platforms. Engineers in this role will first contribute to and grow within our eDiary ecosystem—a regulated, patient-facing platform used across our Epilepsy portfolio. Our engineers work across modern web and mobile applications, secure clinical data platforms, cloud infrastructure, distributed system architectures, API design, auditability frameworks, identity and access control systems, and production observability. When you apply to this position, your profile will be considered for current and future Software Engineer openings supporting the eDiary platform and adjacent clinical systems.

Primary Responsibilities

• Design, develop, and maintain reliable, production-grade code across frontend, backend, and data layers, implementing software solutions that meet clinical, operational, and regulatory requirements
• Deploy and operate services in a cloud environment (AWS preferred) and contribute to architecture and design reviews with a focus on reliability, scalability, and security
• Debug and resolve production issues across distributed and asynchronous workflows; diagnose performance bottlenecks; and own incident response, including root cause analysis and durable fixes that prevent recurrence
• Collaborate with QA, Clinical Operations, Clinical Development, Product, and IT stakeholders to translate requirements into validated releases
• Design APIs and data models that preserve audit trails, version history, and system traceability; and improve system observability through structured logging, monitoring, and alerting
• Uphold high standards for data integrity, security, and regulatory compliance across all systems

Qualifications and Key Success Factors

• Bachelor’s degree in Software Engineering or equivalent practical experience
• 3+ years of non-internship professional software development experience, with demonstrated ability to design, build, and operate production software systems end-to-end
• Demonstrated experience using AI-assisted development tools (e.g., code generation, automated testing, debugging copilots) to improve engineering productivity and code quality, with ability to critically evaluate AI-generated outputs for correctness, security, and maintainability
• Strong foundation in software engineering fundamentals: data structures and algorithms, API and interface design, relational data modeling and transactional integrity, and separation of concerns
• Demonstrated ability to debug complex issues across multiple layers (client, API, database, infrastructure) and trace issues in distributed or asynchronous systems using logs, metrics, and instrumentation
• Experience deploying and operating applications in a cloud environment (any major provider), including networking, access control, configuration, and monitoring; and experience designing secure systems including authentication and authorization flows
• Experience implementing production-grade monitoring, alerting, and CI/CD practices; and ability to work effectively in a remote-first, high-accountability environment
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You’ll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Preferred Qualifications

• Experience building systems with offline behavior, synchronization logic, or conflict resolution
• Experience designing for auditability, traceability, or immutable data models; or operating systems in regulated or compliance-driven environments
• Experience containerizing and deploying services; building modern web applications (TypeScript and React preferred); and integrating with third-party systems or external APIs

A Day in the Life

On a typical day as a Praxis Software Engineer, you might: start with a team sync to align on sprint priorities and release readiness; review requirements with Clinical or QA partners to clarify edge cases; write and test code for a new feature in the eDiary web or mobile application; deploy a service update to the cloud and verify monitoring instrumentation; trace a production issue across client logs, backend APIs, and database queries; perform root cause analysis and implement a long-term fix; participate in a design discussion focused on improving auditability or system reliability; review pull requests and provide structured technical feedback; document logic changes to support validation traceability; and participate in on-call or release-readiness support.

About the Team

The Praxis Software Engineering team operates in a fast-paced, remote, high-accountability environment where engineers own their systems end-to-end, from design and implementation through deployment and ongoing production operations. Engineers may contribute to patient-facing platforms, clinical systems, financial infrastructure, commercial systems, or other enterprise applications. Regardless of domain, quality, data integrity, and reliability are non-negotiable. This role includes active production support responsibilities; ownership extends beyond feature delivery to sustained system reliability, observability, and operational excellence.

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Responsible for translating the processes and products for Praxis’ clinical and commercial pipeline from the laboratory to the manufacturing environment in our virtual development and CMO network.  The individual will use his or her 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 will be needed to ensure our product and processes are efficient and well controlled. S/he will be a leader contributing to ensuring the analytical function is agile and at the forefront in the industry.  This mission-critical role will deliver to product teams within CMC to realize Praxis’ pipeline of innovative medicines for neurological disease. 

Primary Responsibilities

• Involved in all analytical deliverables with CMC program while acting as Analytical lead, including management and execution of analytical testing and for the Analytical Development team and our external network, especially as it relates to method development, validation and GMP testing. This includes technical troubleshooting, data interpretation, reviewing method validation documents, authoring CoA-s, stability reports.  
• Direct management of our external network providers that execute Analytical Development activities to ensure deliverables and continuously improve on efficiency.  
• Leading 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 but also development of our CMC operations function, process improvement.  
• Collaborate with other functions of Praxis CMC to establish the technical and business practices of the team. 

Qualifications and Key Success Factors

• Advanced degree (PhD or Masters degree with related experience) in Analytical Chemistry or related discipline with 5-7 years of industry experience. Preferred with biopharmaceutical innovator or CMO. 
• Industry experience in Analytical Development specifically for small molecule drug substance and solid oral drug products is required 
• Experience with oligonucleotide drug substance and/or drug products desirable  
• Strong knowledge of US and EU cGMP requirements and best practices relating to drug substances and drug products 
• Ability to interpret and implement, as appropriate, compendia-based testing requirements for drug substances and drug products 
• Involvement in reference standard management and stability oversight 
• Experience with CMC development and support across all phases of drug development from initial regulatory filings through registration, validation and launch preferred 
• Experience in support of late-stage / commercial products including product monitoring, improvement and issue resolution preferred 
• Demonstrated success in building and maintaining productive partnerships with third-party CRO /CMO partners and associated service providers to develop and manufacturing pharmaceutical products 
• Fluid and conversant with GMP and quality control 
• Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment. 
• Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all its forms. 
• Highly organized and detail-oriented with a passion to deliver quality results. 
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Praxis is seeking an Associate Director, Statistical Data Scientist to lead and execute the development, validation and automation of analytical pipelines and statistical models that support metadata-driven clinical data processing, reporting, and regulatory submissions. 

This is a hands-on technical leadership role, ideal for a senior data scientist or statistical programmer who enjoys coding, problem-solving, and working cross-functionally to bring rigor, reproducibility, and automation to clinical reporting workflows. 

The Associate Director will contribute directly to R/Python development while also setting technical standards, mentoring peers, and ensuring readiness for R-based regulatory submissions. 

Primary Responsibilities

• 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, ensuring full traceability and audit readiness. 
• Implement and validate statisticall models (e.g., MMRM, ANCOVA, logistic regression) using R packages such as mmrm, emmeans. 
• Collaborate with IT to integrate data science and statistical programming workflows within Databricks and CI/CD pipelines for continuous validation and reproducibility 
• 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; ensuring deliverables meet submission-quality and reproducibility standards 
• Mentor and guide team members in best practices for programming, validation, and automation  

Qualifications and Key Success Factors

• Bachelor’s or Master’s degree in Statistics, Biostatistics, Data Science, or a related field. 
• 8+ years of statistical programming experience in the pharmaceutical/biotech industy including hands-on experience with R and/or Python. 
• Proven experience preparing or supporting R-based regulatory submissions (e.g., R package validation, R-based analysis delivery, or submission readiness) 
• Strong understanding of CDISC ADaM and SDTM data structures, and their use in analytical workflows 
• Experience developing and validating reusable R/Python libraries and functions 
• Proficiency with Git, Bitbucket, and CI/CD automation pipelines 
• Working knowledge of GxP and Part 11 compliance 
• Excellent documentation and validation practices 
• Collaborative and proactive mindset; able to operate independently in a small, agile team. 

Preferred Experience: 

• Familiarity with YAML/JSON configuration and metadata-driven programming workflows 
• Prior experience migrating from SAS to R/Python environments 
• Knowledge of R validation frameworks (e.g., risk-based testing, reproducibility documentation). 
• Experience with exploratory analytics or visualization in R or Python within a regulated framework. 

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job-related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.

Location:  This position is field based and requires 60-80% travel.

The Opportunity

Praxis is seeking a field-based Clinical Trial Liaison (CTL) to partner directly with clinical trial sites and drive high-quality, high-urgency study execution. This is a hands-on, field-facing role focused on building trusted relationships with investigators and site staff, delivering scientific and protocol expertise, and addressing the real-world challenges that impact trial performance.

You will play a critical role across the lifecycle of study execution, from site initiation and training through enrollment and retention, while proactively identifying risks and working cross-functionally to resolve them. This is not a passive support role; you are expected to take ownership of site performance, think critically, and act with urgency to drive results.

We are open to hiring across levels and seek individuals who can operate with a high degree of ownership in the field, whether growing into the role or already leading independently. Leveling will reflect experience, judgment, and demonstrated ability to influence trial outcomes.

Success in this role requires strong clinical credibility, clear and effective communication, and the ability to operate autonomously in a high-travel, fast-paced environment.

Primary Responsibilities

• Serve as the primary scientific and operational lead for assigned clinical trial sites, driving engagement, performance, and accountability in partnership with Clinical Operations and CRO partners.
• Deliver protocol, disease state, and investigational product training to site personnel, ensuring strong study execution and clear understanding of expectations.
• Proactively identify risks to patient recruitment, retention, and protocol adherence—and own mitigation strategies in collaboration with cross-functional teams.
• Develop and execute investigator and site engagement plans to strengthen relationships and optimize trial performance.
• Identify, evaluate, and activate new clinical trial sites, including expanding high-performing networks and accelerating enrollment timelines.
• Represent Praxis at medical and scientific congresses, bringing back insights to inform trial strategy and execution.
• Maintain deep, current knowledge of CNS/neurology landscapes and competitive development, translating insights into actionable recommendations.
• Support adherence to regulatory requirements and Praxis policies and SOPs.

Qualifications and Key Success Factors

• Advanced clinical or scientific degree (PharmD, PhD, MD, NP, PA, or RN)
• Experience in clinical research, clinical care, or field-based roles supporting clinical trials
• Demonstrated ability to interpret and communicate complex scientific and clinical information with clarity and credibility
• Strong ownership mindset with the ability to operate independently, navigate ambiguity and drive results
• Comfort operating in a high-travel (~60–80%), field-based environment
• Proven ability to manage multiple priorities with strong organizational skills, attention to detail and follow-through
• Experience in neurology or CNS disorders preferred
• Candidates with prior field-based experience and a demonstrated track record of independently driving site performance, influencing investigators, and improving trial execution will be considered at a higher level.

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job-related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Praxis is seeking an Senior Medical Science Liaison (Sr. MSL) to lead and develop a team of Medical Science Liaisons (MSLs) supporting pre-launch and launch activities for ulixacaltimide in movement disorders. This is a hands-on leadership role responsible for building, coaching, and directing a high-performing field medical team, while also maintaining strategic engagement with key investigators, movement disorder specialists, and other neurology stakeholders.

This individual will play a critical role in translating medical strategy into field execution, ensuring high-quality scientific exchange, and driving clinical and account readiness in advance of and following potential approval. The role requires a balance of people leadership, strategic thinking, and field engagement, operating as both a coach and scientific leader within a dynamic, fast-paced launch environment.

Given the significant unmet need in essential tremor and the opportunity to introduce a novel therapeutic option, this role will help shape disease education, stakeholder engagement, and the evolving treatment paradigm across both academic and community neurology settings.

The Associate Director/Director will partner cross-functionally with Medical, Clinical Development, Commercial, and Market Access teams to align on strategy, shape field insights, and ensure consistent, compliant execution across the MSL organization.

This role will also be responsible for translating field insights into actionable strategic recommendations, representing the voice of the external medical community, and shaping field medical strategy across the product lifecycle from pre-launch through post-launch adoption.

The role includes responsibility for field team effectiveness, including performance management, territory alignment, and resource deployment to ensure optimal execution and impact.

This role will report directly to the Head of Field Medical Affairs and serve as a key leader within the field medical organization.

Success in this role requires strong clinical credibility, excellent communication skills, strategic thinking, and comfort operating autonomously in a fast-paced environment.

Primary Responsibilities

Team Leadership & Development

• Recruit, onboard, and develop a high-performing team of MSLs, including both senior and early-career talent
• Operate within a player/coach model, providing direct oversight, coaching, and field engagement alongside MSLs
• Establish clear expectations for scientific exchange quality, insight generation, and stakeholder engagement
• Conduct regular field travel and joint visits with MSLs to observe, coach, and elevate performance
• Foster a culture of ownership, accountability, and continuous development across the team
• Foster a high-performing, collaborative team culture grounded in scientific excellence, accountability, and continuous development

Field Strategy & Execution

• Translate medical strategy into a clear, executable field plan aligned with pre-launch and launch priorities
• Oversee territory planning, KOL identification, and stakeholder engagement strategies across regions
• Ensure consistent, high-quality scientific exchange across the team, including disease state education and product data communication
• Support clinical and account readiness efforts, including site preparedness, patient identification, and integration into clinical practice
• Monitor field activity and adapt strategy based on evolving insights and market dynamics
• Lead territory alignment and resource deployment strategies to ensure optimal coverage of key accounts and stakeholders
• Support the evolution of field medical strategy across the product lifecycle, from pre-launch readiness through post-launch adoption and expansion

KOL Engagement & Scientific Leadership

• Maintain direct relationships with key national and regional KOLs, investigators, and thought leaders
• Lead high-impact scientific engagements, including advisory boards, congress interactions, and complex clinical discussions
• Serve as a scientific leader within the organization, ensuring credibility and consistency in external interactions
• Support the identification and development of emerging influencers and strategic partnerships

Insight Generation & Cross-Functional Collaboration

• Oversee the collection, synthesis, and communication of field insights to inform medical and cross-functional strategy
• Partner closely with Clinical Development, Commercial, and Market Access to ensure alignment and effective execution
• Translate field insights into actionable recommendations that shape launch strategy, evidence generation, and stakeholder engagement
• Contribute to the development of medical materials, training, and strategic initiatives as needed
• Represent the voice of the external medical community by translating field insights into strategic recommendations that inform medical and cross-functional decision-making

Operational Excellence

• Ensure all field medical activities are conducted in compliance with regulatory requirements, company policies, and SOPs
• Partner with internal teams to support training, onboarding, and field effectiveness initiatives
• Establish and track key performance indicators for field medical impact and execution
• Support planning and execution of congresses, advisory boards, and other key medical activities
• Establish and monitor key performance indicators (KPIs) to evaluate MSL effectiveness, scientific engagement quality, and overall field impact
• Contribute to field medical planning, including budget, resource allocation, and operational prioritization
• Partner with internal teams to develop and implement onboarding and ongoing training programs to ensure consistent field capability and scientific rigor

Qualifications and Key Success Factors

• Advanced clinical or scientific degree (PharmD, PhD, MD, NP, PA, or RN)
• Experience in medical affairs, clinical research, clinical care, or field-based roles within biotech/pharma
• Demonstrated ability to interpret, communicate, and translate complex scientific and clinical data into clear, actionable insights for diverse stakeholders
• Strong ownership mindset with the ability to operate independently, navigate ambiguity, and drive impact in a dynamic pre-launch/launch environment
• Proven ability to build and maintain trusted relationships with healthcare professionals, including investigators and key opinion leaders
• Experience gathering, synthesizing, and translating field insights into actionable recommendations for cross-functional teams
• Ability to manage multiple priorities with strong organizational skills, attention to detail, and consistent follow-through
• Willingness and ability to travel extensively (~60–80%) in a field-based role
• Demonstrated experience leading, coaching, and developing field-based teams, with the ability to drive performance and accountability
• Proven ability to translate medical strategy into effective field execution and operational plans
• Experience influencing cross-functional stakeholders and aligning teams in a matrixed environment
• Experience in neurology, CNS disorders or movement disorders is preferred
• Experience within market access/payor landscape is preferred
• Demonstrated ability to rapidly develop expertise in new therapeutic areas and apply insights to field strategy
• Candidates with prior field-based experience and a demonstrated track record of independently driving scientific engagement, shaping clinical perspectives, and contributing to successful pre-launch and launch activities will be considered at a higher level
• Candidates with prior experience leading MSL teams, supporting product launches, and driving field medical strategy will be considered at the Director level

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job-related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Praxis is seeking a field-based Medical Science Liaison (MSL) to support Medical Affairs activities for ulixacaltimide during prelaunch and potential launch. This role is focused on building trusted scientific partnerships, delivering high-quality scientific exchange, and generating actionable insights to inform medical strategy and ensure clinical readiness. 

This is a field-facing, development-oriented role where you will engage healthcare professionals and investigators to communicate emerging clinical data, deepen disease state understanding, and identify unmet needs and potential barriers to patient care. You will work closely with cross-functional partners to ensure aligned and compliant execution of prelaunch and launch activities. 

Success in this role requires strong scientific curiosity, effective communication skills, and the ability to operate with guidance while building confidence and independence in the field in a fast-paced environment. 

Primary Responsibilities

• Build and maintain scientific relationships with healthcare professionals, investigators, and key opinion leaders to support Medical Affairs objectives  
• Deliver accurate, balanced, and compliant scientific exchange on disease state, clinical data, and the ulixacaltimide profile  
• Support prelaunch medical readiness by educating stakeholders on emerging data, treatment paradigms, and patient identification considerations  
• Gather, synthesize, and communicate field insights (e.g., unmet needs, treatment patterns, clinical questions) to inform medical strategy  
• Identify and engage developing and established KOLs under the guidance of senior team members  
• Collaborate cross-functionally with internal partners to ensure aligned execution of field activities  
• Represent Praxis at scientific congresses and medical meetings, capturing and sharing relevant insights  
• Maintain up-to-date knowledge of CNS/neurology disease areas, clinical data, and competitive landscape  
• Ensure all activities are conducted in compliance with regulatory requirements, company policies, and industry standards 

Qualifications and Key Success Factors

• Advanced clinical or scientific degree (PharmD, PhD, MD, NP, PA, or RN)  
• Early to mid-career experience in medical affairs, clinical practice, clinical research, or related roles in biotech/pharma  
• Strong ability to learn and communicate scientific and clinical information clearly and credibly  
• Demonstrated ability to build professional relationships with healthcare providers  
• Interest in developing field-based expertise, including insight gathering and scientific engagement  
• Ability to manage multiple priorities with strong organization and attention to detail  
• Willingness to travel extensively (~60–80%)  
• Experience in neurology or CNS disorders preferred  
• Exposure to payer/market access concepts is a plus 
• Candidates with prior field-based experience and a demonstrated track record of independently driving site performance, influencing investigators, and improving trial execution may be considered at a higher level. 

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  

These ranges reflect the base salary ranges the Company reasonably expects to pay for each level at the time of posting. Placement within the range will be based on job-related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.

Senior Clinical Trial Manager (CTM) 

Location:   This position may be performed remotely with travel to the Boston area as needed.   

Position Summary 

This role will be responsible for project management in the initiation, execution and close out of domestic and international clinical studies, including study concept and design, feasibility assessments, study start-up, contract and budget oversight, data exchange and support of data analysis and interpretation. 

This position requires both the knowledge and experience to work within established clinical trial paradigms while exploring and embracing new approaches to conducting research to support data aggregation and analysis to advance patient care. The Sr. CTM will participate on clinical project teams to achieve quality results in a cost-effective and timely manner. S/he will be a key team member to establish key practices and procedures for the clinical team. 

Primary Responsibilities 

• Manage study activities in the successful execution of clinical trials from protocol concept to clinical study report, complying with Good Clinical Practice (GCP) guidelines and international regulations 
• Manage strategic engagement with key collaborators 
• Set-up and oversee clinical trial-related trackers such as regulatory documents, trial master file (TMF), startup progress, screening/enrollment, study invoices/payments, project budgets, etc. 
• Key contributor to IRB/EC and regulatory submissions 
• Oversee TMF reviews to ensure completeness and inspection readiness 
• Regularly review documents to ensure adherence to Clinical Operations and/or project specific quality requirements (e.g. SOPs, work practices, training guides) 
• Identify and mitigate against study risks, escalating as necessary 
• Direct initiatives to identify and implement best practices and continuous improvement plans in clinical development 

Education and Professional Experience 

• Bachelor’s degree in a scientific field required; advanced scientific degree a plus 
• 5+ years directly managing clinical trials in Sponsor or CRO setting 
• In-depth knowledge of clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirements 
• Experience directing members of clinical operations teams 
• Experience working in a team across multiple functional areas (e.g., Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance) 

Other Essentials and Key Success Factors 

• Intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit 
• Ability to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to problem solve 
• Self-motivated and able to work autonomously, as well as a member of a collaborative team 
• Highly-organized and detail-oriented with a passion to deliver quality results 
• Strong verbal and written communication skills with an ability to build relationships internally and externally 
• Highest levels of professionalism, confidence, personal values and ethical standards 

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Praxis is seeking an experienced and strategic Senior Manager/Associate Director of Regulatory Strategy to support global regulatory initiatives and lifecycle management activities across our clinical development programs.  You’ll play a key role in supporting regulatory strategies for ongoing clinical programs, including new INDs, protocol amendments, health authority interactions, and global lifecycle planning.  

This role is ideally suited for a regulatory professional with strong experience in managing and expanding existing INDs and advancing programs through mid- to late-stage development.  The ideal candidate brings experience in small molecule and/or RNA-based therapeutics, strong operational execution skills, and the ability to work cross-functionally to ensure regulatory strategies align with evolving development plans.  This role will be pivotal in supporting global clinical development and regulatory activities for INDs, CTAs, NDAs and MAAs.

Primary Responsibilities 

• Support the development and execution of global regulatory strategies for ongoing clinical-stage programs, with a strong focus on lifecycle management.
• Lead regulatory activities for clinical development programs, including new IND submissions, protocol amendments, annual reports, safety updates, and global CTA maintenance.
• Partner with Clinical Development, Nonclinical, CMC, and Translational teams to align regulatory strategy with evolving development objectives and timelines.
• Prepare and manage regulatory submissions (e.g., IND amendments, new INDs, CTAs, briefing packages) in collaboration with internal stakeholders and external vendors.
• Contribute to preparation for and participation in health authority interactions (e.g., FDA, EMA, MHRA), including meeting strategy, briefing document preparation, and response coordination.
• Provide regulatory guidance to cross-functional teams on clinical trial design, patient selection, and regulatory requirements to support lifecycle activities.
• Support planning for future marketing applications by ensuring development programs are conducted in alignment with global registration requirements.
• Monitor and interpret evolving regulatory guidance and communicate potential impact on ongoing programs.
• Contribute to regulatory intelligence efforts and continuous improvement of regulatory processes. 

Qualifications and Key Success Factors

• Advanced degree (PharmD, MS, or equivalent) in a life science or regulatory-related field preferred; six to ten years of experience in Regulatory Strategy within biotech/pharma, with significant experience supporting clinical-stage development programs.
• Demonstrated experience managing IND lifecycle activities, including protocol amendments, new INDs, and global CTA maintenance.
• Experience supporting health authority interactions and preparing regulatory briefing packages.
• Experience in rare disease and/or neurological indications strongly preferred.
• Understanding of accelerated regulatory pathways (e.g., orphan designation, breakthrough therapy) and their application to lifecycle strategy.
• Strong project management skills and ability to manage multiple concurrent regulatory activities.
• Excellent communication and collaboration skills, with the ability to translate regulatory requirements into actionable development plans.
• Aligned with Praxis’ ways of working – including a collaborative, solution-oriented mindset and the ability to work with urgency, innovation, and integrity.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

POSITION TITLE 

Quality Systems Manager 

Location: This position may be performed remotely but requires flexibility and a willingness to travel to the Boston area as needed. 

Position Summary 

The Quality Systems Manager is responsible for supporting GxP compliance across Praxis programs. They will help design, implement, maintain, and enhance Quality Systems company-wide, including development, pre-clinical, clinical, safety, validation, registration, and commercialization efforts. This role involves serving as a key contributor on GxP compliance and fostering collaborations across various departments. 

The Quality Systems Manager will contribute to the development and execution of a tailored Quality compliance strategy for Praxis and support the evolution of Quality Systems aligned with the company's path to commercialization. 

The ideal candidate will thrive in a results-driven, highly accountable setting with significant potential for impact. They should possess the ability to navigate regulatory landscapes, build effective internal partnerships, and support Quality compliance excellence within the organization. The Quality Systems Manager will contribute to advancing Praxis' mission and driving continuous improvement in Quality Systems to support the company's growth and success. 

Primary Responsibilities 

• Design, implement, and maintain company-wide stage-appropriate Quality Systems aligned with GxP principles. 
• Regularly assess and enhance GxP practices to meet evolving regulations. 
• Collaborate with cross-functional teams to drive GxP excellence. 
• Provide training on GxP requirements to personnel at all levels. 
• Provide coaching and guidance on Quality best practices, procedures, record review, and regulatory requirements. 
• Support implementation and training on new quality processes, supporting quality management initiatives. 
• Conduct compliance risk assessments, trend analysis, and provide recommendations for compliant business activities. 
• Support oversight of the Supplier Quality Management program, Training, and Document Control. 
• Ensure only adequate/approved suppliers and vendors are utilized by the company. 
• Establish, compile, track, and present Quality Metrics to support Quality Management Review. 
• Provide input into decisions required for change management and CAPA programs. 
• Support inspection readiness activities, including participation in internal and external audits and regulatory inspections. 
• Monitor industry inspection trends, regulations, and guidelines for impact on programs and operations. 
• Work with department heads to support data integrity initiatives. 
• Provide feedback on trends and quality issues or non-compliances detected during GMP and GDP activities. 
• Ensure that CAPAs associated with assigned programs and studies are tracked and closed out appropriately and timely. 
• Write, review, or approve Standard Operating Procedures and internal investigations, as applicable. 

Qualifications and Key Success Factors 

• Bachelor’s degree in life sciences, engineering, or a related field (with a preference for Chemistry or Biology) or an equivalent combination of education and relevant job experience may also be considered. 
• 5–7 years of relevant quality experience, including implementing and supporting GxP (Good Practice) quality systems within the pharmaceutical or biotech industry. 
• Experience in Electronic Document Management Systems (EDMS) and Quality Management Systems (QMS); familiarity with Veeva is preferred. 
• Experience working in quality systems and/or quality operations. 
• Strong knowledge of global regulations, particularly those from the EU and US. 
• Strong understanding of GxPs (Good Practices), especially GMP (Good Manufacturing Practices). 
• Proficiency in Microsoft Office, particularly Excel, PowerPoint, and Word. 
• Experience working in a pharmaceutical GMP environment. 
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. 

Compensation & Benefits 

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together! 

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

We’re seeking a Director of Commercial Compliance to build and lead Praxis’s U.S. commercial compliance program in anticipation of up to two potential product launches. This is a foundational role that will shape a scalable, fit-for-purpose, risk-based compliance framework to enable high-integrity, patient-centric commercialization while support business agility.

You’ll operate as a strategic partner across Legal, Regulatory, Medical Affairs, Finance, and Commercial, and serve as a core member of the Promotional Review Committee (MLR) where you’ll provide regulatory, legal, and compliance guidance on promotional materials and activities.  You’ll be expected to lead with clarity, make decisive calls, and co-create solutions that uphold our values while enabling speed and impact in a compliant manner.

Primary Responsibilities

• Design, implement, and scale Praxis’s commercial compliance program in advance of first launch, including policies, SOPs, governance, risk assessment, monitoring and training.
• Establish launch-ready corporate compliance controls supporting commercial operations, including:
• HCP interactions (speaker programs, advisory boards, consulting)
• Transparency and reporting (e.g., Sunshine Act / Open Payments)
• Patient support, access, and hub-related activities
• Commercial contracting, transfers of value, and third-party oversight
• Serve as a standing MLR member, providing regulatory, legal, and compliance review of promotional materials.
• Ensure alignment with FDA regulations, OPDP guidance, and company standards.
• Partner with Commercial and Medical teams to enable efficient, compliant review and messaging.
• Define MLR processes, timelines, precedents, and escalation pathways.
• Train internal stakeholders on promotional compliance, scientific exchange, and appropriate data use.
• Advise on compliant use of clinical, safety, and real-world data across promotional and non-promotional channels.
• Conduct launch-focused compliance risk assessments and implement monitoring activities.
• Support investigation and remediation of commercial compliance issues in partnership with Legal and HR.

Qualifications and Key Success Factors

• Bachelor’s degree; advanced degree preferred (JD, PharmD, MD, PhD, or MPH)
• 5+ years of experience in commercial compliance, legal, regulatory, or promotional review within biopharma - CNS, neurology, or rare disease experience preferred.
• Experience building or scaling commercial and/or corporate compliance programs.  First launch or early commercial build-out experience preferred.
• Hands-on participation in MLR/Promotional Review Committees.
• Strong knowledge of FDA advertising and promotion regulations, OPDP guidance, and corporate compliance principles for commercial operations.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

As Director of Process Chemistry, you will take the lead on drug substance activities for one or more projects within Praxis’ portfolio of small molecule and ASO programs to drive forward both clinical and commercial readiness.  You’ll design products & processes that support clinical phase testing and then mature those processes through development to Commercial supply.  Working intimately within the CMC and project teams under Agile management you’ll identify requirements and constraints of our product to define a workplan that will lead to the successful manufacturing and creation of a data package to support commercial regulatory submissions. 

This role is ideal for someone who thrives in a fast-moving, collaborative environment, where science meets ownership. You’ll help define product requirements, anticipate challenges, and co-create practical, creative solutions that accelerate progress for patients in urgent need. 

Primary Responsibilities

• Leads the Process Chemistry Research and Development for one or more projects from early to late phase within Praxis.  
•  Designs both early phase and late-phase/commercial drug substance process and then leads their demonstration from lab to pilot plant.  
• Provides chemistry and technical leadership throughout the lifecycle  
• Participates/leads activities to identify final API forms for pharmaceutical development.  
• Working closely with formulations, analytical, operations, engineering and quality, expectation to be integrated into the overall CMC team responsible for delivery of clinical and commercial drug substance to Praxis programs. 
• Identify, collaborate and lead external CRO, and CDMO organization(s) to achieve deliverables. 
• Analyze external experimental data to drive synthetic experimental plans at CROs and CDMO. 
• Authoring or co-authoring of regulatory submissions.  
• Define manufacturing strategy and execution, including GMP requirements and issue resolution.  
• Assessment and application of new trends and concerns in process development, quality and manufacturing to Praxis’ products. 
• Manage quarterly budgeting of drug substance relevant activities.  
• Contributor to inventions that add value to Praxis and its patients while strengthening our intellectual property position.   

Qualifications and Key Success Factors

• Advanced degree or commensurate experience equivalent in Chemistry, Pharmaceutical Sciences, Engineering or related discipline.  
• Minimum of 12 years of industry experience in CMC specifically for small molecule drug substance.  
• A scientific track record or working knowledge in continuous processing, biocatalysis, catalysis, and/or high throughput experimentation desirable.  
• Strong knowledge of US and EU cGMP requirements and best practices relating to drug substances and drug products.  
• Strong knowledge of CMC development across all phases of drug development from initial regulatory filings through registration, validation and launch.  
• Experience in working with third-party CRO / CMO partners and associated service providers to develop and manufacturing pharmaceutical products.  
• Experience with salt/crystalline form selection preferred.  
• Experience with oligonucleotide chemistry is a plus  
• Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment.  
• Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all its forms.  
• Highly organized and detail-oriented with a passion to deliver quality results.  
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

The Senior Director of Quality Excellence (Systems & Technology) is a strategic quality leader responsible for shaping, executing, and continuously advancing the enterprise Quality Management System (QMS) and Quality systems operating model across Praxis Precision Medicines. This individual provides vision and direction for all Quality Systems functions including Veeva QMS governance, document control, GxP training administration, validation, and inspection readiness and leads supplier oversight for Quality Systems and GxP computerized system providers, including audit program execution ensuring a compliant, efficient, and scalable quality infrastructure that supports the company’s global clinical, manufacturing, and commercial operations. 

The Senior Director serves as the organization’s subject matter expert on GxP system compliance, regulatory readiness, and quality systems excellence. This role is accountable for the strategy, oversight, and continuous improvement of Praxis’s QMS and validation programs, ensuring all GxP systems including those supporting clinical data (EDC, eCOA/ePRO/eDiary), manufacturing and supply chain (serialization, ERP, LIMS), and supporting quality systems are fit for intended use and maintained in a controlled state using risk-based lifecycle practices aligned with current industry expectations (e.g., CSA concepts and GAMP 5). 

Partnering closely with senior leadership across Quality, Clinical, Technical Operations, and IT, the Senior Director drives a culture of proactive quality, operational discipline, and continuous improvement to ensure the highest standards of regulatory compliance and inspection readiness across the enterprise from clinical development through commercial operations. 

Primary Responsibilities

• Lead the strategy, governance, and continuous improvement of Praxis’s enterprise QMS to ensure compliance with global GxP regulations and alignment with corporate and regulatory objectives. 

• Serve as the process owner for QMS elements including document control, deviation/CAPA management, change control, training, and risk management, ensuring process effectiveness and harmonization across all GxP functions. 

• Provide leadership and oversight for computerized lifecycle controls (CSV/CSA) for GxP computerized systems, ensuring systems supporting clinical, manufacturing, and commercial operations are maintained in a compliant state including internally developed applications and externally hosted/vendor-managed SaaS platforms. 

• Partner with IT, Clinical Operations, Technical Operations, and Commercial teams to establish -based lifecycle standards that ensure system suitability, data integrity, and consistent execution (requirements, testing, release/change control, periodic review, and decommissioning/archiving). 

• Evaluate and qualify vendors, CROs, and CMOs supporting Praxis systems, providing QA oversight supplier documentation and oversight activities, and lead supplier oversight for GxP computerized systems (quality agreements/oversight plans, risk-based audits, performance monitoring, and CAPA follow-up as applicable). 

• Maintain oversight of electronic systems, including Veeva QMS, ensuring appropriate configuration, document hierarchy, and workflow management. 

• Lead the global GxP training administration program, including development of curricula, compliance tracking, and training effectiveness measurement. 

• Establish and oversee QMS governance mechanisms, including Quality Management Reviews, issue escalation processes, and risk management frameworks. 

• Ensure ongoing inspection readiness across all GxP functions, maintaining compliant systems, documentation, and records suitable for regulatory and partner audits and lead backroom support and response coordination as needed. 

• Monitor evolving regulatory expectations, guidance, and industry trends; implement timely updates to processes, procedures, and computerized systems lifecycle practices. 

• Define, monitor, and report key QMS and validation metrics to assess performance, identify trends, and drive data-driven improvements. 

• Lead, mentor, and develop a high-performing team of QMS and validation professionals, fostering accountability, collaboration, and continuous learning. 

• Represent Quality leadership in enterprise governance and initiatives, providing expert guidance on GxP system compliance, quality risk management, and digital transformation. 

• Drive sustained inspection readiness and execution support, including post-inspection commitments and CAPA to closure. 

Qualifications and Key Success Factors

• BS/BA in a relevant scientific discipline, or ASQ or equivalent professional certification; equivalent experience considered. 

• Minimum 15 years of progressive experience in the pharmaceutical or biotechnology industry, with direct Quality Systems and Quality Assurance experience; at least five years in a leadership role. 

• Demonstrated expertise in developing, implementing, and managing enterprise QMS’ across clinical, manufacturing, and commercial functions. 

• Proven success governing QMS processes such as document control, training, deviation/CAPA, change management, and risk management, ensuring operational consistency and compliance. 

• Hands-on experience validating GxP and enterprise systems, ensuring compliance with lifecycle management, change control, and data integrity principles including experience with internally developed systems and SaaS/vendor-managed platforms. 

• Demonstrated leadership experience supporting both clinical-stage and commercial operations environments (ability to scale systems and expectations across the product lifecycle). 

• Documented history supporting regulatory inspections and partner audits, including inspection readiness leadership, backroom support, response coordination, and CAPA execution to closure. 

• Strong working knowledge of FDA, EMA, and global GxP regulations (21 CFR Parts 11, 210, 211, 312) and application of GAMP 5 guidance and familiarity with current risk-based validation approaches (CSA concepts). 

• Demonstrated ability to analyze and optimize quality processes, establish meaningful performance metrics, and lead cross-functional governance forums. 

• Strategic, solutions-driven quality leader with excellent collaboration, communication, and influencing skills. 

• Proficient in Veeva Vault applications (QualityDocs, QMS, Clinical, RIM, Training), as well as DocuSign and SharePoint.  

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

This role is responsible for medical writing activities for one or more clinical development programs at Praxis, as directed by the Associate Director, Medical Writing. The individual will complete accurate, high quality, and regulatory compliant documents in support of clinical trials and regulatory submissions. This position requires the knowledge and expertise to collaboratively author required documents with support from the Associate Director, Medical Writing while also helping teams follow medical writing processes and style requirements. 

Primary Responsibilities

• Implements all activities related to the preparation of defined medical and regulatory documents, serving as writing lead on assigned documents or identifying when external writers are necessary for support 
• Supports documents for regulatory submissions to US and global health authorities, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), protocols, investigator brochures, clinical study reports, briefing documents, regulatory responses to health authority questions, and scheduled reports. 
• Collaborates with cross-functional team members, eg, Clinical Pharmacology, Toxicology, Research, Clinical Development, Regulatory Affairs, Biostats, Data Management, Quality, CMC, QC, etc., to ensure accurate and timely completion and delivery of high-quality, scientifically-sound documents, slide decks, and publications 
• Supports clinical trial transparency and disclosures, including clinical trials registration and results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide 
• Contributes to departmental development through editorial and review support for document templates, style standards, reviewer guidelines, and standard operating procedures to ensure consistent and high-quality deliverables 
• Ensures adherence to relevant SOPs and internal best practices 

Qualifications and Key Success Factors

• Bachelor’s degree required within a scientific discipline, advance degree, CNS, and Rare Disease experience a plus 
• 4+ years of medical writing experience in Sponsor or CRO setting 
• AMWA certification preferred 
• Experience using medical writing systems and technologies including Veeva RIM 
• Knowledge of drug development, study conduct processes, ICH guidelines, and FDA/EU guidance or demonstrated success within a regulated industry environment  
• Highly organized and detail-oriented with a passion to deliver quality results quickly
• Strong verbal and written communication skills with an ability to build relationships internally and externally
• Highest levels of professionalism, confidence, personal values, and ethical standards

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Reporting to the Head of Pharmacovigilance, the Senior PV Scientist supports the medical oversight, analysis, coding, interpretation, and reporting of pharmacovigilance data at Praxis. This role contributes to high-quality safety surveillance, signal detection, benefit-risk evaluation, and regulatory compliance across clinical development programs.  

As Praxis advances its pipeline and prepares for regulatory submissions, this position plays a critical role in strengthening U.S.-based pharmacovigilance footprint, enhancing vendor oversight, supporting implementation of evolving safety infrastructure, and ensuring inspection readiness. The Associate Medical Director, PV Scientist enables the PV Lead to focus on clinical safety strategy, regulatory submission activities, and labeling development by providing both strategic and operational support across safety activities. 

Primary Responsibilities

• Serve as the U.S. facing PV leader, ensuring timely follow-up on safety actions across global teams and time zones. Proactively identify and resolve operational gaps before they become compliance risks. 
• Own oversight of end-to-end PV service providers, including governance meetings, KPI monitoring, TMF documentation, and continuous process improvement. Ensure quality, timeliness, and regulatory compliance at all times. 
• Contribute to the development and evolution of PV SOPs, safety management plans, and database migrations. Lead or support implementation of new safety tools (e.g., signal detection platforms, monitoring systems) to strengthen proactive surveillance. 
• Support signal detection activities, literature review, aggregate report preparation, and safety governance meetings. Author signal assessments, benefit-risk evaluations, and health hazard evaluations with scientific rigor and clarity. 
• Prepare and/or QC safety narratives, regulatory safety responses, IND/NDA/MAA components, and DSMB materials. Ensure TMF documentation is complete, accurate, and inspection ready. Maintain compliance with global safety reporting requirements. 
• Collaborate with Clinical Operations, Regulatory, Medical Affairs, Commercial, and Quality to ensure aligned safety processes, including call center setup, partner safety data exchange, and commercialization readiness activities. 
• Ensure safety data exchange complies with partner agreements. Author searches for strategies for regulatory queries and internal requests. Maintain rigorous documentation standards to support inspections and audits. 

Qualifications and Key Success Factors

• Nurse, Nurse Practitioner, Pharmacist, or Allied Health Professional.  
• Minimum 3-5 years of experience in pharmacovigilance within the pharmaceutical/biotechnology industry.  
• At least 1 year of clinical trial experience highly desirable.  
• Experience with regulatory filings (INDs, NDAs, MAAs).  
• Strong knowledge of FDA, EMA, ICH, and GVP pharmacovigilance regulations.  
• Experience in individual case safety reporting (clinical and post-marketing), aggregate reporting, signal detection, risk management planning, regulatory inspections, and PV SOP development.  
• Experience implementing safety databases and signal detection tools preferred.  
• Familiarity with MedDRA and WHO-Drug coding.  
• Excellent written and verbal communication skills. 

Key Success Factors at Praxis 

• Ownership mindset: You act like the safety infrastructure is yours. You don’t wait for direction to solve problems. 
• Operational rigor: You create clarity in ambiguity and ensure documentation withstands inspection scrutiny. 
• Scientific judgment: You understand the difference between noise and signal and contribute meaningfully to benefit-risk discussions. 
• Speed with precision: You move quickly without sacrificing quality. 
• Cross-functional credibility: You build trust across Clinical, Regulatory, Medical Affairs, Commercial, and external partners. 
• Builder mentality: You enjoy scaling systems, not just operating within them. 
• Candid communicator: You raise risks early, directly, and constructively. 

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Praxis is seeking an experienced Associate Director within our Data Management team to serve as the primary point of contact on assigned studies and programs - driving decisions, resolving issues, and contributing to cross-functional planning and execution.  You will also oversee the performance of external data management partners for assigned studies and programs. This is a hands-on role requiring strong judgment, technical expertise, and a collaborative mindset.  If you are energized by building fit-for-purpose systems, navigating complexity with curiosity and ownership, and working at a company where patients come first, we’d love to meet you. 

Primary Responsibilities

• Directly contributes to the oversight of Data Management service providers and external vendors on assigned studies and programs, ensuring milestones and quality deliverables are achieved on time, within budget, and in accordance with regulatory requirements.  
• Serves as the point of contact for decision making and resolution within and across studies and programs.  
• Reviews and approves Data Management related documentation for quality, completeness, and accuracy; including but not limited to Case Report Forms, Data Validation Specifications, Case Report Form Completion Guidelines, Data Management Plans, Data Transfer Agreements, Medical Coding Guidelines, User Acceptance Testing (UAT) documentation, Communication Plans, etc. 
• Performs secondary User Acceptance Testing (UAT) of the EDC system prior to deployment to the production environment. 
• Contributes to and oversee the development of the Integrated Oversight Plan, establishing an internal cross-functional oversight plan to ensure data quality and demonstrate oversight; conducts DM data review per the plan using appropriate tools and systems. 
• Ensures the timely provisioning of feedback on draft protocols, risk assessments, and functional area plans and outputs as appropriate (e.g. Medical Monitoring Plan, Statistical Analysis Plan (SAP), Clinical Study Reports (CSR), Tables, Listings and Figures, etc.). 
• Participate in continual development through the acquisition and enhancement of knowledge related to drug development, clinical trials methodology, and DM best practices, and apply the information to make recommendations for improvement to processes and business performance. 
• This position is an individual contributor role and does not carry direct reports.  However, if the business needs change direct line management may be required in the future. 

Qualifications and Key Success Factors

• Bachelor’s degree required within a scientific discipline, pharmaceutical sciences, engineering, or related field.  CNS experience a plus. 
• Requires a minimum of 5 years of Clinical Data Management experience in a pharmaceutical or CRO setting; 7+ years preferred 
• Significant experience in managing outsourced data management activities. 
• Thorough understanding of the drug development process, clinical trial methodology, regulatory requirements, and GCP. 
• Current and extensive knowledge of industry Data Management best practices and processes and understanding of Risk Based Quality Management (RBQM) principles. 
• Strong experience with computerized systems including EDC (preferably Medrio, Medidata RAVE), IRT, eCOA, and ePRO. 
• Experience with data visualization tools (e.g.Power BI, Spotfire) and advanced analytics systems (e.g. Medidata CSA, CluePoints) preferred. 
• Strong and effective oral and written communication, project management, and interpersonal skills are required. 
• CCDM is preferred. 
• Knowledge of SAS and database programming, systems integration experience and understanding of CDASH and CDISC standards are preferred.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Praxis is seeking a Senior Accountant to support both core accounting operations and FP&A activities as the company continues to scale. This role will play a key part in the monthly close process while also partnering with the FP&A team on budgeting, forecasting and analytical support. 
 
Praxis operates with a lean, collaborative finance team structure. While this role will have a primary manager, different aspects of the work will be reviewed and guided by multiple team members across Finance. The successful candidate will be comfortable operating in this environment, managing priorities across stakeholders and contributing wherever needed. 

Primary Responsibilities

• Support the monthly general ledger close process, including preparation and review of journal entries, reconciliations and supporting schedules. 
• Assist in preparation of commercial related accruals and R&D accruals, including coordination with functional stakeholders and timely recording in the general ledger. 
• Perform cash reconciliations as part of the monthly close process and investigate and resolve variances. 
• Assist with the preparation of monthly, quarterly and annual financial reporting deliverables. 
• Support budgeting and forecasting activities in collaboration with the FP&A team, including data gathering, analysis and tracking of actuals versus forecast. 
• Maintain and improve accounting processes, documentation and controls to support accuracy and scalability. 
• Collaborate cross-functionally to ensure timely, accurate financial information and support ad hoc analyses as needed. 

Qualifications and Key Success Factors

• Bachelor’s degree in Accounting, Finance or a related field. 
• 3+ years of progressive accounting experience, preferably within biotech, pharmaceutical or life sciences companies. 
• Strong understanding of general ledger accounting, accruals and account reconciliations. 
• Experience supporting monthly close processes in accordance with U.S. GAAP. 
• Interest in and aptitude for FP&A, including budgeting and forecasting support. 
• Strong attention to detail, organizational skills and ability to manage multiple priorities. 
• Comfortable working in a collaborative, fast-paced environment with multiple reviewers and stakeholders.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

As Executive Director of Process Chemistry, you will be the enterprise leader for Praxis’ drug substance strategy across our full portfolio, spanning small molecules and oligonucleotides. You’ll set the vision and execution path for API development from early-stage clinical through global commercialization—aligning scientific innovation, regulatory foresight, and supply chain scalability to deliver high-impact therapies with speed and rigor. Operating as a key architect of our CMC strategy, you’ll integrate deeply with Research, Development, Manufacturing, and Commercial to ensure seamless translation from bench to bedside. This is a mission-critical role for a bold and visionary leader committed to accelerating patient impact.

Primary Responsibilities

• Own and drive the global API strategy across Praxis’ portfolio, ensuring scientific excellence, regulatory alignment, and supply chain scalability from IND through commercial launch. 
• Lead the design, development, and industrialization of robust, phase-appropriate drug substance processes—championing modern technologies such as continuous flow, biocatalysis, and digital process design. 
• Act as a thought leader and decision-maker in CMC governance forums, ensuring tight alignment between drug substance strategy and broader program objectives. 
• Build and lead a high-performing, multidisciplinary ecosystem of internal talent and external partners (CROs/CDMOs), holding to the highest standards of execution, accountability, and innovation. 
• 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—driving unified CMC plans that anticipate risk and accelerate timelines. 
• Represent Praxis externally with regulators, partners, and scientific communities—contributing to our reputation as a science-driven, execution-focused innovator in CNS therapeutics.

Qualifications and Key Success Factors

• Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline. 
• 12+ years of progressive leadership in process development and CMC strategy, with deep expertise in both early-stage and late-stage development. 
• Proven track record of leading API development and scale-up through global regulatory submissions and commercial launch. 
• Deep technical knowledge spanning small molecules and oligonucleotides, with fluency in emerging manufacturing technologies. 
• Strong leadership in global vendor and alliance management, with a history of building and sustaining high-functioning external networks. 
• Strategic thinker with exceptional problem-solving skills and the ability to drive clarity in complexity. 
• Operates with urgency, scientific rigor, and enterprise thinking to enable bold patient impact.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Praxis is hiring a dedicated and experienced leader to serve as Head of Global Medical Affairs.  You'll be responsible for building and leading the team with the goal of enhancing the development and commercialization of our neuroscience pipeline.  As a key contributor you will work closely with a cross-functional group that includes counterparts in Research & Development and Commercial to implement and ensure an all-encompassing strategy. This is an outstanding opportunity to serve as a driving force in building medical affairs excellence at Praxis.  The role will actively participate in strategic planning, ongoing and new development projects, existing and future corporate alliances, and partnering discussions. It is an ideal opportunity for a hands-on builder who brings both scientific rigor and strategic judgment—someone energized by creating Medical Affairs excellence from the ground up and translating complex science into real impact for patients.

Primary Responsibilities

• Build out and lead the medical affairs function to support commercial launches of new products into the marketplace. 
• Lead, manage and develop a best-in-class, high-performance medical affairs team and related support functions. 
• Identify, define and implement process and operating procedures for this group which are consistent with general guidance already in place for the development organization. 
• Develop and manage a Medical Science Liaison team and a Medical Information team. 
• Develop and implement Medical Communication and Disease State Awareness strategies. 
• Develop and execute life cycle management plans. 
• Partner with KOLs to gather information on current focused therapeutic area issues and questions. 
• Lead the development of product publication plans, key opinion leader engagement plans, medical education plans, advisory boards, medical symposia, congress activities and compassionate use/post-trial access programs. 
• Collaborate with the Clinical Development and Commercial teams with the development of education material for providers and patients that is medically accurate and appropriate. 
• Possess an understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with customers. 
• Provide direction and input to deliver integrated evidence to support successful reimbursement and market-access strategies. 
• Work closely with members of the senior management team, to develop the overall strategic direction for Praxis; evaluate alternative strategies, identify competitive issues, capitalize on core strengths, and develop and implement operating plans to achieve objectives for profitable growth. 
• Help represent Praxis in the context of conferences, presentations, industry, and investment groups. 

Qualifications and Key Success Factors

• Advanced Scientific or Clinical degree is required (MD, PhD or PharmD) with a demonstrated passion for neuroscience. 
• Minimum of 15 years of applicable experience within a medical affairs leadership role in the pharmaceutical industry, including global experience. 
• Demonstrate an ability to build, lead and develop a team of highly performing and motivated medical affairs individuals. 
• A visionary business leader with a track-record of inspiring, influencing, and supporting direct and cross functional teams. 
• Prior experience thriving in a small/entrepreneurial setting is preferred. 
• Highly developed written and verbal communication skills, including ability to effectively articulate highly technical/complex scientific data and concepts to audiences with various levels of scientific and technical knowledge. 
• Excellent understanding of healthcare and a curiosity for business opportunities. 
• Customer-focused: Keep patients, payers and physicians front and center in their daily work and collaborate to solve critical scientific and business challenges. 
• Ability to lead by example, attract and develop talent, build interdependent partnerships and create a culture of collaboration and teamwork that fosters open communication, constructive conflict resolution and organizational flexibility. 
• Extensive experience in launch and commercialization of specialty drugs and direct interaction with the FDA and international regulatory agencies is highly desirable.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Submit Your Resume for Consideration of Future Opportunities

At Praxis Precision Medicines, we dare for more in every aspect of what we do, advancing our portfolio of therapies for central nervous system disorders—to make the impossible possible.

If you’ve explored our current openings and haven’t found one that fits your qualifications, we invite you to submit your information via this general interest link. While there may not be a position for you today, having your information available can help us determine applicability for future opportunities and possible outreach.  

This form allows you to share your resume and basic personal information with our Talent Team for possible consideration of future job openings.

Important:

• Using this link is not an application for a specific open position.
• Submitting your information does not guarantee that you will be contacted or considered for future positions.
• You may request to modify your information at any time by contacting us at careers@praxismedicines.com.