Praxis Precision Medicines, Inc.

Develop and execute the company's investor relations strategy, communicate scientific and financial stories, and manage investor relationships. | 8-12+ years in investor relations or related fields within biotech or life sciences, with strong scientific, financial, and regulatory knowledge. | Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Praxis is hiring a Director of Investor Relations who will be focused on translating our momentum into meaningful market understanding. You will be responsible for developing and sharing the company’s investor relations strategy – one that effectively communicates the company’s scientific, clinical, commercial, and financial story to the investment community. You’ll serve as a key liaison between the company and public market investors, sell-side analysts, and other stakeholders, ensuring consistent, accurate, and compliant disclosure while supporting capital markets activities and long-term shareholder value creation. The ideal candidate brings deep capital markets expertise, shareholder engagement, and a strong grasp of the biotechnology sector, clinical development, and regulatory milestones. Primary Responsibilities Collaborate with key stakeholders to execute a comprehensive investor relations strategy aligned with corporate objectives and long-term value creation. Articulate a clear and compelling investment thesis that integrates scientific rationale, clinical data, regulatory strategy, and financial outlook. Lead preparation of earnings materials, investor presentations, fact sheets, Q&A documents, and corporate messaging. Keep track of investor interactions, organize meetings, coordinate presence at investor conferences including developing a strategy for identifying and meeting a target list of investors. Oversee investor-facing sections of press releases, SEC filings, and the corporate website for consistency and accuracy. Serve as a primary point of contact for institutional investors, analysts, and proxy advisory firms. Manage earnings calls, investor days, conference participation, non-deal roadshows, and one-on-one investor meetings. Build and maintain strong relationships with sell-side analysts and ensure accurate coverage. Partner with Finance, Legal, and external advisors to ensure compliance with SEC regulations and Reg FD requirements. Monitor peer activity, valuation trends, sell-side price targets & valuation models, and industry developments within the biotech and life sciences sector. Approximately 25% travel, including investor conferences, roadshows, and meetings. Qualifications and Key Success Factors Bachelor’s degree in finance, Life Sciences, Business, or a related field; advanced degree (MBA, PhD) strongly preferred. 8–12+ years of relevant experience in investor relations, equity research, investment banking, corporate finance, or a related role within biotechnology or life sciences. Prefer experience in a publicly traded biotech company. Demonstrated understanding of biology of the mechanism of action in the portfolio, strong scientific background, clinical development stages, regulatory pathways, and biotech valuation drivers. Strong knowledge of U.S. securities regulations, disclosure requirements, and capital markets best practices. Exceptional written and verbal communication skills, with the ability to translate complex scientific and financial concepts into clear investor messaging. Preferred ability to convey deep scientific concepts with investors and other 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. Annualized Base Salary $200,000—$228,000 USD Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

Lead and manage a small IT support team, triage tickets, ensure SLAs are met, and improve support processes. | Over 3 years of managing IT support teams, strong troubleshooting skills, experience with Microsoft enterprise environments, and customer service orientation. | Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Praxis is seeking a Service Desk Manager to lead our IT Support Team and ensure excellent technical service delivery across the company. This role is vital to keeping our IT support experience fast, clear, and reliable. As the first line of escalation from our Service Desk Specialists, you’ll triage tickets, optimize routing, and partner across the business to resolve issues quickly. You’ll also drive process improvements, support ongoing maintenance work with our Tier II team, and proactively manage hardware and licensing needs. This is a hands-on leadership role, ideal for someone who’s energized by problem-solving, team coaching, and delivering high-integrity support in a dynamic environment. Primary Responsibilities Manage day-to-day ticket intake performance and ensure SLAs are met or exceeded Serve as the primary point of escalation for Tier I tickets, resolving issues or coordinating handoff to Tier II as needed Support the Tier II team on ongoing IT maintenance and infrastructure projects Identify and escalate trends in hardware and licensing needs before they impact the business Coach, mentor, and develop a small team (3–4) of Tier I Service Desk Specialists Partner cross-functionally with internal teams and external vendors to ensure seamless service Develop documentation, workflows, and training to improve consistency and efficiency Qualifications and Key Success Factors 4+ years of hands-on experience with Microsoft enterprise environments, including Entra ID (Azure AD), Microsoft 365, Defender for Endpoint, and related tools 3+ years of experience managing a service desk or IT support team Proven ability to lead, coach, and develop Tier I support staff Strong troubleshooting skills across hardware, software, and systems in a corporate environment Demonstrated customer service orientation — responsive, clear, and empathetic in every interaction Able to triage effectively, prioritize under pressure, and manage workload in a fast-paced setting Experience with ITSM tools, endpoint management platforms, and remote support technologies Detail-oriented, proactive, and highly accountable — you take ownership and follow through 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. Annualized Base Salary $100,000—$122,000 USD Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

Lead quality oversight strategies for clinical and commercial supply chains, ensuring GMP compliance and supporting regulatory inspections. | Over 10 years of GMP experience, managing stability programs, and supporting regulatory inspections, with a strong understanding of quality systems and interfacing with external partners. | Location: This position may be performed remotely with travel to the Boston area as needed. Requires ability to travel domestically and internationally to meet program needs (estimated 15-20%).  Position Summary The Associate Director, Quality Operations – Commercial & Stability, CMC will lead the development and execution of quality oversight strategies across commercial and clinical supply chains, with a focus on stability programs. This strategic role is accountable for ensuring GMP compliance in support of global product distribution, driving operational excellence, and building strong cross-functional partnerships across Quality, Manufacturing, Regulatory Affairs, and external partners. The ideal candidate brings a sharp strategic lens, operational rigor, and a strong quality mindset. Primary Responsibilities • Provide strategic leadership for commercial and clinical stability programs, ensuring global regulatory compliance and proactive risk management. • Oversee quality operations related to 3PL contract service providers (CSPs), ensuring robust quality systems and oversight for distribution and release activities. • Lead the development, review, and approval of key product and process documents including regulatory submissions, stability protocols, mock recalls, and annual product reviews (APR/PQR). • Own quality review and approval of change controls, deviations, investigations, temperature excursions, CAPA, and Product Quality Complaints. • Guide field alert reporting (FAR) strategies, including trending analysis and early detection systems. • Serve as the quality lead for commercial readiness initiatives, regulatory inspections, and pre-approval inspection activities. • Collaborate closely with Regulatory Affairs, Manufacturing, and external partners to drive continuous improvement, maintain inspection readiness, and resolve issues with urgency and clarity. • Represent Quality in cross-functional strategic discussions and governance forums. • Ensure cohesive collaboration across CSPs for timely review of GMP records  • Support pre-approval inspection and commercial readiness activities, internal and external audits  Qualifications and Key Success Factors • BA or BS degree in Chemistry or related field. • 10 + years in a GMP setting working with clinical and commercial products.  • Experience managing stability programs. • Direct experience with recall, APR, FAR management. • Firsthand experience with interpreting and implementing of regulatory standards (e.g., ISO, FDA, ICH, GMP, EMA).  • Proven ability to operate independently, influence cross-functionally, and make clear, timely decisions. • Proven track record and experience in supporting regulatory inspections (FDA, EMA).  • Strong knowledge of quality management systems, QC and development processes, and regulatory strategy for small molecule DS and solid oral drug products.  • Experience with interfacing with a QP and CSPs. • Excellent written, organizational, and oral communication skills.  • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.   • Experience with product monitoring, complaint handling, and issue resolution preferred. • 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 their forms.   • Highly organized and detail-oriented with a passion to deliver quality results.   • Ability to travel domestically and internationally to meet program needs (estimated 15-20%).  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! Annualized Base Salary $163,000—$183,000 USD Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

Partner with CMOs to validate and optimize drug manufacturing processes, ensuring compliance with regulations and standards. | Requires extensive pharmaceutical manufacturing experience, knowledge of cGMP, and strong communication skills, which are not reflected in your background. | Location: This position may be performed remotely with travel to the Boston area as needed. Position Summary: Praxis is seeking a skilled and driven Process Engineer to partner closely with our Contract Manufacturing Organizations (CMOs) to validate and optimize drug product manufacturing processes—primarily oral dosage forms. You’ll play a key role in ensuring readiness for future commercial production and maintaining appropriate supply levels. The right candidate brings hands-on engineering expertise, excels in leading day-to-day CMO communication, and serves as a trusted point of contact for seamless knowledge transfer between Praxis and our manufacturing partners. Primary Responsibilities: Ability to understand varied formulation processes and transfer drug product processes for industrialized execution by authoring scale up spreadsheets and process manuals. Efficient use of technologies and applications to gather, analyze and archive large data packages that can support regulatory filings. Review relevant documentation from CMOs and lab partners including instructions, procedures, batch records, non-conformances, in-process controls, bulletin of analysis, developmental reports. Work alongside Quality Assurance to ensure all proper regulations and standards are followed in all our processes being executed by third parties. Adhere to industry guidelines, standards and laws including being well-versed in cGMPs. Travel required - PIP at CMOs (US and worldwide) Qualifications and Key Success Factors: Advanced degree in chemical engineering, pharmaceutical sciences or other relevant engineering field, MS or equivalent a plus. Pharmaceutical industry experience required, e.g. process operations knowledge of sifting, milling, blending, roller compaction, tableting, coating among others. 8 years’ with a BS degree or 6 years’ with an MS degree of applied experience in CMO management, drug product manufacturing, or comparable positions that handle diverse environments, reviewing Manufacturing and Executed Batch records, operating procedures, non-conformances, change controls, and fostering business partner relationships. Excellent written and visual communication skills with an ability to build relationships internally and externally Self-motivated and able to contribute to a productive and collaborative team environment Highly organized and detail-oriented with a passion to deliver quality results 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. Annualized Base Salary $145,000—$167,000 USD Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

Oversee global drug safety activities, ensure compliance with regulations, and lead PV operations and vendor relationships. | Requires 8+ years in pharmacovigilance, with experience in PV procedures, case processing, and managing PV for small molecules or antisense oligonucleotides, which are not reflected in your experience. | Praxis Precision Medicines, Inc. has an opening for a Senior Director, Safety/Pharmacovigilance in Boston, MA. 40 hours/week. 5% short-term travel, including up to 1% international travel and 4% domestic. Remote/telecommuting position, can work from anywhere within the U.S. DUTIES: Providing oversight and daily management of all activities pertaining to drug safety within the Praxis pharmacovigilance (PV) department globally. Includes: leadership and oversight of global PV operations, personnel and strategic resource planning; oversight of developing compliant PV procedures and training modules; oversight of timely safety reporting to regulatory authorities and external business partners; implementation of strategies to manage safety risks; ensure PV department maintains inspection readiness, including representing the company during audits and pharmacovigilance inspections; monitor key performance indicators for PV vendors; collaborate cross-functionally to ensure timely authoring of key safety deliverables including periodic safety updates and regulatory query responses; and lead PV/safety aspects of NDA/MAA preparation, including authoring of integrated safety summary and drafting labeling. Leads capabilities enhancement within PV, including implementation of safety database and data visualization tools for signal detection. Oversight of relationships with external business partners, including overseeing the alliance, associated requests, and PV agreements, ensuring mechanisms are in place for governance of partnerships. MIN. REQ.: MD, DO, PharmD, PhD, or foreign equivalent in Medicine, Pharmacy, or related clinical field, such as Epidemiology or Public Health. 8 years of experience in a Pharmacovigilance role within the Pharmaceutical / Biotechnology industry. SPECIAL REQ.: 8 years of experience ensuring PV procedures remain compliant with regulatory guidance by maintaining knowledge of good Pharmacovigilance practices and the evolving regulatory landscape. 8 years of experience in pharmacovigilance case processing, including case management, and individual and aggregate case reporting. 8 years leading PV operations, including oversight of third-party vendors. 4 years of experience implementing post marketing and clinical trial safety surveillance and reporting requirements. 1-year minimum experience implementing post marketing and clinical trial safety surveillance and reporting requirements in decentralized trials. 4 years of experience interacting externally and internally to support the scientific and business strategy. 3 years of experience managing PV for small molecules and antisense oligonucleotides, for both rare and prevalent diseases. PAY TRANSPARENCY: Wage ranges from $277,826 to $301,159/year. Apply on the Praxis Precision Medicines, Inc. career website: https://praxismedicines.com/#careers #LI-DNI #LI-DNP Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

Plan and execute CMC regulatory strategies, manage regulatory submissions, collaborate with cross-functional teams, and lead responses to health authority inquiries. | Minimum 8 years industry experience with 5 years in regulatory affairs focused on CMC, scientific degree, deep knowledge of FDA and global regulations, and strong communication and leadership skills. | Senior Manager, CMC Regulatory Affairs Location: This position has the ability to work remotely with regular travel to the Boston area as needed. Position Summary The Senior Manager, CMC Regulatory Affairs will be responsible for planning and executing the CMC regulatory strategies for assigned development programs. You will partner with CMC technical leads, Quality Assurance, and other technical areas to develop optimized plans for successful regulatory submissions. Primary Responsibilities Actively participate on CMC development teams to plan regulatory strategies by defining pathways and milestones for submissions to support development activities leading to successful study authorizations and ultimately marketing approvals Align CMC regulatory plans with cross-functional development and manufacturing teams Execute regulatory strategies: track and manage progress within defined timelines Articulate complex CMC regulatory issues to project teams and external stakeholders to support global development and commercialization of assigned drug candidates Independently and in collaboration with CMC team members, write Module 3 sections to support INDs, IMPDs, NDAs and MAAs. Critically evaluate health authority questions and lead the team of cross-functional SMEs to write responses. In collaboration with CMC team members, write questions and briefing documents in support of Health Authority meetings such as Type C meetings with FDA, and Scientific Advice meetings with EMA. Evaluate proposed manufacturing and quality changes for impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes Facilitate the development of, reviews, and comments on all technically complex CMC documentation for submission to regulatory authorities including process development, process validation, analytical method development, and analytical method validation supporting establishment of specifications and in-process, release and stability data and information appropriate to phase of development Manage processes: collaborate cross functionally with teams and departments to generate CMC regulatory documents including reviews and resolution of comments Disseminate global CMC regulations and guidelines with appropriate interpretation Education and Professional Preferred Experience Minimum of BS or BA in a scientific or technical discipline, advanced degree preferred. Equivalent combination of education and applicable job experience may be considered Industry experience of 8 years, of which at least 5 years spent in regulatory affairs with CMC responsibilities Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including US FDA and international regulatory requirements (EMA, ICH, Health Canada, LATAM and others), guidance, accelerated regulatory review paths, and policy trends, with expertise in small molecule and oligonucleotide-based product development preferred Proven track record of delivering in a biotech start-up, fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful Expertise in navigating matrixed organizations and working effectively with all levels of management, cross-functional stakeholders, and individual contributors across the company Experience with Veeva Vault is a plus 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 environment. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, and program recommendations. Persistent but polite/respectful in proactively driving change, and able to deal with a diverse group of people with different strengths, skills, and methods of interacting with others while gaining their support. Team player willing to roll up their sleeves as the situation requires to get the right result; ability to combine hands-on attention to detail with the ability to step back and think strategically Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks. Self-motivated, comfortable with independently making decisions and communicating in a direct fashion, able to 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 Approaches his/her work with professionalism, integrity and personal confidence 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! Annualized Base Salary $110,000—$130,000 USD Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

Oversee and manage stability studies and analytical testing programs in collaboration with CDMOs ensuring compliance with regulatory guidelines and supporting product development. | Bachelor's degree in Analytical Chemistry or related field with 7+ years in GMP-regulated pharmaceutical environment and hands-on experience with stability and reference standard programs. | Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity We are seeking a Manager/Senior Manager to support and strengthen our growing CMC team. The ideal candidate will leverage previous laboratory-based experience to provide operational oversight of analytical testing and stability programs in collaboration with Contract Development and Manufacturing Organizations (CDMOs) that provide small molecule drug substance and drug product services to the pharmaceutical industry. This role is critical to ensure that the Praxis analytical testing network is robust and operates at peak performance. In addition, you will be responsible for overseeing the execution and lifecycle management (planning, set-up, and execution) of stability studies across Praxis' development portfolio, ensuring compliance with ICH guidelines and regulatory expectations. The role requires close coordination with CDMOs, internal Analytical Development, Drug Substance and Drug Product teams, CMC Outsourcing, Quality Assurance, Regulatory CMC, and Manufacturing functions to ensure timely generation and interpretation of analytical testing and stability data that support product shelf-life, storage, and regulatory submissions. Primary Responsibilities • Collaborate with and support stakeholders within Analytical Development, Regulatory CMC, and Quality Assurance to ensure alignment on stability strategies and compliance with ICH guidelines. • Ensure that analytical documentation (protocols, reports, change controls, etc.) are added contemporaneously to Praxis' document management system. • Contribute to regulatory filings (e.g., IND, IMPD, NDA) by preparing stability summaries and providing supporting information. • Collaborate with other functions of Praxis CMC to execute the technical and business practices of the team. • Lead the establishment, execution, and management of stability studies internally and at CDMO partners for drug substance and drug products across all development phases, ensuring alignment with regulatory and project timelines. • Monitoring CDMO performance with respect to agreed timelines for providing stability protocols and reports and establishing metrics, as needed • Review of raw data, calculations, stability protocols, and stability summary reports in direct support of the Analytical Development Project Leads. • Perform trend analysis of stability data to be used in shelf-life assessment. • Ensure timely data review to support OOT/OOS investigations and implementation of corrective actions related to stability studies. • Monitor the execution of our reference standard lifecycle management, including qualification, requalification, inventory, and expiry tracking in coordination with external testing sites. Qualifications and Key Success Factors • Bachelor's degree in Analytical Chemistry or a related discipline with at least 7 years of relevant industry experience in a GMP-regulated environment; advanced degree a plus but not required. • Hands-on experience supporting stability and reference standard programs for small molecule drug substances and oral drug products (e.g., tablets, capsules, suspensions), including sample tracking, data trending, and documentation. • Strong, working knowledge of stability study tracking software, such as Smartsheet, to monitor stability studies and evaluate CDMO performance. • Working knowledge of US and EU cGMP requirements, ICH guidelines and compendial standards (e.g., USP, EP) applicable to stability studies and reference standards. • Demonstrated success in building and maintaining productive partnerships with CDMO partners and associated service providers to ensure the company's objectives are achieved. • Strong communication skills and the ability to work effectively with cross-functional teams including Analytical Development, Quality Assurance, and Regulatory Affairs. • Ability to support investigations and trending activities, including compilation of stability data tables, graphs, and summaries for internal and regulatory use. • Strong attention to detail along with the ability to perform meticulous data review and data transcription review. • Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile 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! 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. Annualized Base Salary $145,000-$175,000 USD Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.