\nAbout Us\nDianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.\n\n\nAbout the Role\n\nAs the Senior Clinical Data Manager, you will have play a critical role within the team.\n\nReporting to the Director, Data Management, you will be responsible for overseeing all clinical data management and related deliverables from start-up through close out of various clinical trials. This individual will independently support assigned active programs to ensure complete, accurate, high quality and regulatory compliant data in support of study reports, publications and regulatory submissions. This position requires both the knowledge and experience to work within established clinical trial paradigms while embracing new approaches to support data aggregation and analysis in the advancement of patient care.\n\nWe are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.\n\nKey Responsibilities\n\n\n* Responsible for relationships with Data Management partners (eg, CROs and vendors) from protocol development through database lock to ensure data are collected, reviewed and delivered with high quality, are on-time and within scope.\n\n* Oversight of outsourced study-related DM activities including CRF design, data collection, edit checks and listings reviews, data reconciliation (SAEs, labs, other external data), medical coding, UAT testing, database lock and archival of DM documents.\n\n* Accountable for ensuring data quality and timeliness of DM deliverables are met and align with company goals\n\n* Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the Trial Master File\n\n* Other related duties as may be determined or assigned\n\n\n\n\nExperience\n\n\n* University degree required within a relevant discipline – Life Sciences experience is a plus\n\n* Comprehensive understanding of DM related systems, technologies and standards\n\n* Comprehensive knowledge of drug development and clinical research processes, GCP guidelines and regulations related to clinical data management\n\n* Self-motivated and able to work autonomously as well as within a high-functioning and collaborative team environment\n\n* Highly organized and detail-oriented\n\n* Strong verbal and written communication skills with the ability to build relationships internally and with external partners\n\n* Highest levels of professionalism, confidence, personal values and ethical standards\n\n\n\n\n \n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n $65,000 — $120,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States

\nAbout Us\nDianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.\n\n\nAbout the Role\n\nAs the Senior Clinical Data Manager, you will have play a critical role within the team.\n\nReporting to the Director, Data Management, you will be responsible for overseeing all clinical data management and related deliverables from start-up through close out of various clinical trials. This individual will independently support assigned active programs to ensure complete, accurate, high quality and regulatory compliant data in support of study reports, publications and regulatory submissions. This position requires both the knowledge and experience to work within established clinical trial paradigms while embracing new approaches to support data aggregation and analysis in the advancement of patient care.\n\nWe are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.\n\nKey Responsibilities\n\n\n* Responsible for relationships with Data Management partners (eg, CROs and vendors) from protocol development through database lock to ensure data are collected, reviewed and delivered with high quality, are on-time and within scope.\n\n* Oversight of outsourced study-related DM activities including CRF design, data collection, edit checks and listings reviews, data reconciliation (SAEs, labs, other external data), medical coding, UAT testing, database lock and archival of DM documents.\n\n* Accountable for ensuring data quality and timeliness of DM deliverables are met and align with company goals\n\n* Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the Trial Master File\n\n* Other related duties as may be determined or assigned\n\n\n\n\nExperience\n\n\n* University degree required within a relevant discipline – Life Sciences experience is a plus\n\n* Comprehensive understanding of DM related systems, technologies and standards\n\n* Comprehensive knowledge of drug development and clinical research processes, GCP guidelines and regulations related to clinical data management\n\n* Self-motivated and able to work autonomously as well as within a high-functioning and collaborative team environment\n\n* Highly organized and detail-oriented\n\n* Strong verbal and written communication skills with the ability to build relationships internally and with external partners\n\n* Highest levels of professionalism, confidence, personal values and ethical standards\n\n\n\n\n \n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n $65,000 — $120,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States

\nAbout Us\nDianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.\n\n\nAbout the Role\n\nAs the Director, Clinical Development Scientist (CDS), you will play a key role in designing and execution of the important clinical studies. You will be part of the team leading the first in patients, clinical trial/s involving a novel complement inhibitor. Success of these trial/s will support further clinical development of the novel asset/s with significant positive impact on multiple stakeholders, including patients suffering from rare, life-threatening neurological conditions.\n\nYou will report to our Vice President, Clinical Development and will provide input into a clinical study protocol and support a clinical study team. You will support assigned clinical development physician leader and the therapeutic area head with deliverables necessary for effective and efficient clinical study design and execution. You must have strong scientific background in in the areas of neurology and/or immunology. Prior experience in drafting of study documents such as protocols and regulatory filings is essential. You must have excellent oral, and written communication skills, with the ability to work independently in a fast paced, entrepreneurial setting involving internal and external stakeholders. \n\nThis is a unique opportunity where you have a chance to positively impact lives as part of the team driven by continuous innovation with very high scientific integrity. We are building a team who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.\n\nKey Responsibilities\n\n\n* Collaborating on, or leading where appropriate, the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.\n\n* Liaising with other functions to enable quality clinical study execution; Provide input to the study team for country and site feasibility assessments.\n\n* Collaborating with the clinical study team in site identification and selection and provide assistance with study start-up activities; Participate in the development of clinical study protocol concept sheets and protocols, study operations manuals, and other study essential documents.\n\n* Participating in virtual or on-site initiation (and/or feasibility) meetings.\n\n* Monitoring, cleaning, analyzing and reviewing safety and efficacy data to establish the presence or absence of trends and follow up as appropriate.\n\n* Supporting the design and execution of key elements of the Clinical Development Plan (clinical study or studies) and associated data collection activities.\n\n* Liaising with other functions to arrange external expert consultations, contribute to the development of study concepts, protocol designs, and study essential documents.\n\n* Engage with clinical investigators on clinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define the clinical strategy. Support CRAs/CROs on study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures. Finally, engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.\n\n* Reviewing and synthesizing scientific literature and competitive intelligence to support study and program strategy.\n\n* Maintaining awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.\n\n* Supporting development of presentations and publications arising from studies and other relevant initiatives.\n\n* Providing support for business development activities, such as due diligence and research collaborations.\n\n* Where appropriate, serve as the SME for identification, training, translation, inclusion, implementation and reporting related to the study endpoints. \n\n\n\n\nExperience\n\n\n* Advanced scientific degree (M.S., Ph.D., Pharm D., MPH or similar degree)\n\n* Understanding of general (specifically rare disease, immunology or neurology) therapeutic principles\n\n* Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation\n\n* Familiar with scientific literature searches and weighing of quality peer reviewed data\n\n* Ability to clearly communicate to internal and external stakeholders orally and in writing\n\n* Neurology and/or rare disease therapeutic area experience\n\n* Basics of strategic vs. tactical thinking\n\n* Experience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.\n\n* Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results\n\n\n\n\n \n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design and Design jobs that are similar:\n\n $70,000 — $100,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States

\nAbout Us\nDianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.\n\n\nAbout the Role\n\nThis role is responsible for overseeing data-specific timelines and deliverables (both internal and external) from start-up through close out of various clinical trials. This includes coordination and timing for data transfers, internal and external data reviews, data deliverables for interim/final analyses, DSMB meetings and any other data-related deliverables.\n\nYou will report to the Director, Data Sciences and will independently support all active programs to ensure complete, accurate, high quality and regulatory compliant data in support of internal or external stakeholders, study reports, publications and regulatory submissions. This position requires both the knowledge and experience to work within established clinical trial paradigms while embracing new approaches to facilitate data aggregation and analysis in the advancement of patient care.\n\nThis is a unique opportunity to be part of a team driven by continuous innovation with very high scientific integrity and who hold our core principles at the center, with the goal to elevate the care of our patients’ lives. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.\n\nKey Responsibilities\n\n\n* Cultivate and manage relationships with DM partners (eg, CROs and other vendors) and cross functional team members to ensure data are reviewed and delivered with high quality, are on-time and within scope\n\n* Accountable for ensuring timeliness of data deliverables are met and align with company goals\n\n* Monitor and track data-related timelines and deliverables and serve as central point of communication for other cross-functional team members\n\n* Document data workflows for assigned studies, ensuring transfers occur based on study-specific needs\n\n* Support the development of standard operating procedures (SOPs) and processes with a focus on continuous improvement and increased efficiency\n\n* Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing relevant data processes, documents, outputs and filing documentation in the trial master file (TMF).\n\n* Other related duties as may be determined or assigned.\n\n\n\n\nExperience\n\n\n* University degree required within a relevant discipline. Life Sciences experience is a plus.\n\n* Skilled in management of timelines and coordination with internal and resources to efficiently reach deliverables\n\n* Comprehensive understanding of DM related systems and technologies\n\n* Comprehensive knowledge of drug development and clinical research processes, GCP guidelines and regulations related to clinical data management\n\n* Self-motivated and able to work autonomously, as well as a member of a high-functioning and collaborative team.\n\n* Highly organized and detail-oriented.\n\n* Strong verbal and written communication skills with an ability to build relationships internally and externally.\n\n* Highest levels of professionalism, confidence, personal values and ethical standards.\n\n\n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n $40,000 — $80,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States

\nAbout Us\n\n\nDianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.\n\n\n\nAbout the Role\n\nAs the Director, Device Quality Engineer, you will be responsible for oversight of our combination product design team and have direct impact on the overall success of our device development along with the engineering teams.\n\n\n\nReporting to the Head of Quality, you will be the sole device Quality Engineer and will play a crucial role in ensuring the quality and safety of our combination products, with a focus on autoinjectors. Day to day, you will work closely with our device development leader and other cross-functional teams to help oversee vendors for end-to-end product development lifecycle.  You will be an active member of the project team, fostering engineering best practices, and maintaining project goals that will improve patient’s lives.   You must have experience as a lead design quality engineer, with specific experience as part of an auto-injector design team.\n\nThis is a unique opportunity to join a growing organization and have a significant impact on our combination product development. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.\n\n\n\nKey Responsibilities\n\n\n* Writes and revises SOPs, controlled forms, and related documents to ensure best practices and maintain compliance to applicable regulations, guidance’s, or compendia.\n\n* Participate in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required.\n\n* Lead or co-audit on device vendor audits in support of vendor qualification including preparation of audit agenda, audit report, and follow-up with vendor on corrective actions.\n\n* Actively participate in routine (e.g. weekly) meetings with device vendors and consultants to support project milestones.\n\n* Execute the phases of Design Controls during product development.\n\n* Support regulatory audits as a Subject Matter Expert for Design Controls and other aspects of the quality system.\n\n* Support and ensure internal & external audit responses and on-time product re-certifications.\n\n* Additional duties may be identified by functional management based on current project/business objectives.\n\n* Ensures that outputs comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.\n\n* Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.\n\n* Support initiatives as identified by management and in support of the Quality Management Systems (QMS), and other regulatory requirements.\n\n\n\n\nExperience\n\n\n* Bachelor's degree Engineering\n\n* Experience in Design Quality Engineering, with a focus on combination products. Autoinjector development experience is a plus.\n\n* Strong knowledge of regulatory requirements for combination products, including ISO 13485, ISO 14971, ISO 11608, 21 CFR Part 820, EU MDR, ISO 14644,  and ability to interpret applicability to Dianthus’s application.\n\n* Strong capability to perform risk analysis and facilitate cross-functional risk analysis meetings.\n\n* Utilize quality tools including Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.\n\n* Ability to lead root cause analysis investigations (Fishbone/Ishikawa diagrams, etc.)\n\n* Deep understanding of Design Control, Process Validation (IQ/OQ/PQ) and Verification Testing, Test Method Validation & Statistical Techniques\n\n* Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.,\n\n* Detail-oriented with a focus on continuous improvement and innovation.\n\n\n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design and Engineer jobs that are similar:\n\n $55,000 — $110,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States