Dianthus Therapeutics

👥 11-50💰 $230,000,000 Post-IPO Equity about 1 year agoBiotechnologyBiopharmaHealth Care📈 Public Company
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Dianthus Therapeutics is a clinical-stage biotechnology company pioneering novel monoclonal antibody treatments for severe autoimmune and inflammatory diseases. Our lead product, DNTH103, targets a specific part of the immune system and is designed for self-administration in some patients. We're making a significant impact in the biopharma industry by focusing on improved selectivity and potency, leading to more effective and targeted therapies. Our tech stack includes a robust mix of modern technologies such as Cloudflare JS, Google Cloud, and Cloudinary, reflecting our commitment to efficient and scalable development. We foster a collaborative engineering culture that embraces innovative approaches and prioritizes data-driven decision-making. We value scientific integrity, continuous learning, and a dedication to improving patient lives. We offer remote work opportunities and support a diverse and inclusive environment. Dianthus is a publicly traded company (NASDAQ: DNTH) with a strong funding history and a growing team of experienced professionals in biotech and pharma. We are actively expanding our team to support the advancement of DNTH103 through clinical trials and eventual commercialization. Join us in our mission to bring life-changing treatments to patients battling serious autoimmune diseases. We offer a supportive and flexible work environment which embraces remote work. Join our growing team and make a significant impact on the lives of patients suffering from autoimmune diseases. We are committed to providing transformative medicines for people living with severe autoimmune and inflammatory diseases.

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📍 North America

🔍 Biotechnology

  • MD required.
  • Minimum total of 5 years of experience in medical affairs and/or clinical development.
  • Extensive experience in the biotech or pharmaceutical industry, particularly in rare autoimmune diseases, Neurology or other rare diseases.
  • Excellent communication, presentation, and relationship-building skills.
  • Strong knowledge of the FDA and North American Healthcare landscape, regulatory environment, and market access challenges.
  • Fluency in English; proficiency in additional languages is an asset.
  • Ability to travel across North America as needed.
  • Lead the development and execution of the North American medical affairs strategy in alignment with global objectives.
  • Ensure the dissemination of accurate, balanced, and scientifically sound medical information.
  • Develop and maintain relationships with top regional KOLs, HCPs, and patient advocacy groups.
  • Provide medical expertise to support ongoing clinical trials.
  • Ensure compliance with regional regulatory requirements, ethical guidelines, and company policies.
  • Lead and mentor a team of medical affairs professionals.

LeadershipComplianceRelationship buildingStrong communication skillsTeam managementStakeholder management

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📍 USA

🔍 Biotechnology

  • Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
  • Minimum of 5–8 years of experience in medical device development, specifically with autoinjectors or pre-filled syringes.
  • Strong knowledge of design controls, risk management, and usability engineering principles.
  • Hands-on experience with mechanical design tools and simulation software.
  • Proven track record in device testing and analysis.
  • Familiarity with materials used in drug delivery devices.
  • Comprehensive understanding of relevant regulatory requirements.
  • Design History File experience.
  • Lead the design and development of autoinjectors, pre-filled syringes, and other parenteral drug delivery devices.
  • Ensure that selection of materials, components and service providers results in a robust product design.
  • Work closely with cross-functional teams to ensure designs meet user needs and regulatory standards.
  • Develop and validate prototypes through rigorous testing and analysis.
  • Conduct design verification and validation studies.
  • Oversee project timelines, budgets, and deliverables.
  • Prepare and review technical documentation in compliance with regulations.
  • Partner with external suppliers to source components.

Project ManagementProduct designComplianceQuality AssuranceRisk ManagementPrototyping

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📍 United States

🔍 Biotechnology

  • Bachelor’s degree or equivalent additional experience or certifications.
  • 10+ years of Payroll and Accounts Payable experience.
  • Strong communication and presentation skills.
  • Demonstrated experience in process improvement.
  • Ability to manage complex projects.
  • Experience with Microsoft Office products, particularly strong in Excel.
  • Strong analytical and process skills with attention to detail.
  • Ownership of semi-monthly payroll process.
  • Full-cycle accounts payable processing, including vendor setup and maintenance.
  • Daily data entry for payables and transaction processing including credit card and banking transactions.
  • Reconcile vendor statements and manage vendor relationships.
  • Ensure accuracy and authorization of invoices before payments.
  • Create reports for internal and external parties.
  • Provide backup and support for the accounting department.

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📍 UK, EU, Nordic regions

🔍 Biotechnology

  • Minimum Undergraduate degree in Life Sciences or equivalent; advanced degree preferred.
  • Experience in clinical research and successful leadership in clinical trials.
  • Strong knowledge of international regulatory and ICH GCP guidelines.
  • Preferred experience in direct line management and project team oversight.
  • Ability to manage complex budgets and understanding of drug development processes.
  • Proficiency with computer applications including EDC, IVR/IWRS, CTMS.
  • Excellent communication skills and ability to work independently and in teams.
  • Willingness to travel and work across diverse cultures.
  • Oversee and direct clinical operations resources while influencing strategy and executing global clinical programs.
  • Manage planning, budgeting, and study management processes for clinical studies.
  • Manage external service providers and internal teams for clinical trial execution.
  • Contribute to protocol development and operational strategies.
  • Conduct risk analyses aligned with corporate strategies.
  • Improve operational efficiency and manage resource strategies for drug development.
  • Ensure effective communication across projects, participate in clinical submissions, and represent the company in regulatory meetings.

LeadershipProject ManagementResource PlanningCollaborationComplianceBudgetingQuality Assurance

Posted about 2 months ago
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📍 USA

🧭 Full-Time

🔍 Biotechnology

  • MD with board certification in the US, preferably with clinical experience in Neurology.
  • Experience leading clinical research in pharma/biotech/CRO settings.
  • Strong leadership skills and ability to work with cross-functional teams.
  • Excellent written and verbal communication skills.
  • Thorough understanding of GCP/regulatory requirements.
  • Proactive attitude towards identifying challenges and implementing solutions.
  • Ability to collaborate with internal teams and external vendors.
  • Open-mindedness and willingness to seek guidance as needed.
  • Providing clinical leadership and strategic medical input for clinical deliverables.
  • Leading development of regulatory documents including Clinical Trial Protocols and amendments.
  • Executing the program and/or clinical trial in partnership with stakeholders.
  • Supporting the Vice President in clinical development plans.
  • Medical monitoring of clinical trial/s and data safety reviews.
  • Developing strategies for timely recruitment.

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