Dianthus Therapeutics

👥 11-50💰 $230,000,000 Post-IPO Equity about 1 year agoBiotechnology Biopharma Health Care📈 Public Company

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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Jobs at this company:

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🔥 Senior Director, Medical Writing

Posted about 1 month ago

🔍 Biotechnology

🔧 Requirements

Advanced degree in life sciences preferred; minimum BS/BA required
12+ years’ experience in a medical writing capacity within drug development
Working knowledge of clinical research, study design, pharmacology, biostatistics, regulatory requirements, and medical terminology
Experience leading medical writing teams responsible for global marketing authorization applications
Exceptional information gathering and conceptual skills
Ability to analyze, interpret, and summarize highly complex data
Outstanding project management and organizational skills
Adept at facilitating the open exchange of ideas and opinions to achieve consensus
Ability to work effectively under pressure and meet time-sensitive deadlines
Demonstrated experience mentoring medical writers, managing project work, and supervising internal and external writers
Proficient in the use of MS Word, Endnote, Adobe Acrobat, PleaseReview, and structured document templates
Experience with inspection readiness activities and representing MW during GCP inspections
Proactive team player, collaborative, resourceful, and flexible

💡 Responsibilities

Independently author and manage others in creation of clear and concise, submission-ready clinical and regulatory documents
Lead writing strategy, drive document content and organization, establish and manage timelines, and ensure adherence to regulations and guidelines
Oversee document review and comment resolution process
Participate in Rapid Response Teams to support timely delivery of responses to Health Authority Information Requests
Generate and maintain templates, style guides, and quality control checklists that drive consistency
Plan strategically, anticipate problems, and recommend process improvements to address current and future needs
Develop budget and resource strategies to ensure on schedule completion of medical writing deliverables using a mix of internal and external medical writers
Serve on cross-functional teams working on SOPs, process improvements, and integration of new tools and technologies
Coach, develop, and support writers (internal and external)
Act as subject matter expert for development of data transparency deliverables
Oversee medical writing resourcing to support publication plans and ensure consistency of messaging with clinical and regulatory submissions
Ability to travel 10-15% for functional team meetings and company events

Posted about 1 month ago

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🔥 Senior Manager, Search and Evaluation

Posted about 1 month ago

🧭 Full-Time

🔍 Biotechnology

🔧 Requirements

Advanced degree (Ph.D., PharmD, or M.D.) in a life science discipline preferred, particularly in immunology; Master’s degree with significant industry experience will be considered
7+ years of experience in the pharmaceutical, biotechnology, or healthcare industry, with a focus on business development, search & evaluation, or 4+ years work experience in management consulting, investment banking, or venture capital / private equity direct investing experience in healthcare
Deep understanding of the autoimmune (inflammation and immunology) therapeutic landscape, including key disease areas and emerging research trends
Proven experience in assessing mechanisms of action, evaluating preclinical and clinical data, and conducting due diligence
Strong analytical skills with the ability to synthesize complex information into strategic insights
Strong project management skills with attention to detail and the ability to manage multiple priorities
Ability to work collaboratively in a fast-paced, dynamic environment
Excellent verbal, written, and interpersonal skills required
Strong knowledge of drug development and biotech/pharma industry
Aptitude for quantitative analysis such as forecasting and valuation work
Experience leading cross-functional teams and presenting business cases to executive management

💡 Responsibilities

Identify and evaluate potential partnerships, licensing, and acquisition opportunities in the severe autoimmune therapeutic space
Conduct comprehensive scientific and strategic assessments of company pipelines, research programs, and mechanisms of action
Partner with key stakeholders across functional areas, including research, clinical, commercial, regulatory and finance
Coordinate diligence efforts and scientific reviews for identified opportunities; review opportunities and business cases with senior leadership
Analyze and monitor the competitive landscape, including emerging trends, clinical development activities, precedent business development transactions and key global players in the autoimmune space
Conduct market research to assess unmet medical needs, therapeutic opportunities, and commercialization potential
Provide actionable insights to inform business development strategies and decision-making
Prepare and deliver compelling presentations and reports for weekly BD meetings, senior leadership, and key stakeholders
Represent the company at scientific, business development, and partnering meetings

Posted about 1 month ago

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🔥 Director, Corporate Counsel

Posted about 2 months ago

🔍 Biotech or pharmaceutical

🔧 Requirements

Juris Doctor (JD) degree from an accredited law school.
Admission to the bar in at least one state.
Minimum of 4 years of relevant legal experience, preferably in the biotech or pharmaceutical industry.
Extensive experience with clinical contracts and familiarity with clinical trial processes.
Proven expertise in corporate governance, SEC filings, and business development transactions.
Strong understanding of federal securities laws and regulations.
Excellent negotiation, drafting, and communication skills.
Ability to work independently and as part of a cross-functional team.
High degree of professional ethics and integrity.

💡 Responsibilities

Draft, review, and negotiate contracts, with a focus on clinical contracts, including clinical trial agreements, investigator-initiated studies, and CRO agreements.
Provide legal support for clinical operations and ensure compliance with applicable laws and regulations, including GDPR and other data privacy matters.
Assist in the preparation and maintenance of corporate records and governance documents.
Support the Board of Directors and executive team with governance matters, including meeting preparation and minutes.
Prepare, review, and file periodic reports, proxy statements, Section 16 filings, and other documents required by the Securities and Exchange Commission (SEC).
Ensure compliance with federal securities laws and stock exchange regulations.
Support mergers, acquisitions, collaborations, licensing, and other strategic business development activities.
Advise on general corporate law matters, including employment, intellectual property, and regulatory compliance.

Posted about 2 months ago

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🔥 Senior Director, Clinical Operations

Posted about 2 months ago

📍 United States, Canada

🧭 Full-Time

🔍 Biotechnology

🔧 Requirements

10-15 years in pharmaceutical or medical device industry
Undergraduate degree in Life Sciences or equivalent
Excellent knowledge of international regulatory guidelines
Experience in direct line management
Ability to manage large complex budgets

💡 Responsibilities

Oversee global clinical operations resources
Manage and lead clinical operations team members
Contribute to clinical trial protocol development
Participate in Clinical submission activities
Develop training plans and conduct performance reviews

LeadershipProject ManagementCross-functional Team LeadershipResource PlanningComplianceBudgetingRisk Management

Posted about 2 months ago

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🔥 Director, Regulatory Affairs

Posted about 2 months ago

🔍 Biotechnology

🔧 Requirements

Bachelor's degree and a minimum of 8 years of experience in Regulatory Affairs; rare disease, neurology, CMC, and/or combination product experience a plus.
Demonstrated track record of successful interactions with FDA and other Health Authorities.
Expert understanding of scientific principles and regulatory requirements relevant to global drug development.
Preparation of nonclinical and clinical sections of regulatory filings, including IND/CTAs, PIPs, briefing documents, and BLA/MAAs.
Preparation for and conduct of Regulatory meetings with global Health Authorities for complex issues.
Strong interpersonal skills and the ability to collaborate effectively with subject matter experts.
Demonstrated leadership, problem-solving ability, flexibility, and teamwork.
Excellent communication, writing, and presentation skills, with the ability to effectively convey critical information to project teams, senior management, and external stakeholders.
Strong project management skills.
Ability to work effectively in a fast-paced, collaborative, and dynamic environment.

💡 Responsibilities

Represent regulatory on cross-functional teams; provide leadership and strategic direction for regulatory deliverables.
Lead planning and provide hands-on support for development and on-time delivery of clear and persuasive global regulatory submission documents, including INDs/CTAs, DSURs, pediatric investigation plans (PIPs), responses to Health Authority (HA) queries, and briefing documents.
Identify, communicate, and propose resolutions to routine and complex strategic issues.
Serve as primary contact and build trusted relationships with Health Authorities for assigned program(s).
Maintain expert knowledge in US and international regulations and provide proactive regulatory intelligence.
Assess opportunities and oversee applications for expedited pathways (eg, fast track or breakthrough designation or PRIME) and/or orphan drug designations.
Lead preparation for and conduct of Health Authority meetings.
Guide development of core data sheet.
Evaluate competitive landscape, regulatory approval pathway(s), and labeling precedent(s).
Identify, engage and collaborate with external regulatory experts and consultants.
Perform regulatory strategic assessments for new product candidates and new indications.
Support departmental initiatives, including process and infrastructure development, regulatory intelligence, budgeting, and authoring of departmental documents (eg, SOPs and Regulatory Development Plans).

Posted about 2 months ago

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🔥 Executive Director, Medical Affairs – APAC Regional Head

Posted 2 months ago

🔍 Biotechnology

🔧 Requirements

MD required.
Minimum total of 10 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
Proven track record of successfully leading medical affairs strategies and teams and or clinical development programs at a regional level.
Strong knowledge of the Asia Pacific healthcare landscape, regulatory environment, and market access challenges.
Fluency in English; proficiency in additional languages is an asset.

💡 Responsibilities

Lead the development and execution of the APAC medical affairs strategy in alignment with global objectives.
Provide medical insights to support business and regulatory decisions
Ensure the dissemination of accurate, balanced, and scientifically sound medical information.
Develop and maintain relationships with top regional KOLs, HCPs, and patient advocacy groups across APAC region.
Provide medical expertise to support ongoing clinical trials.
Ensure that all medical affairs activities are conducted in compliance with regional regulatory requirements, ethical guidelines, and company policies.
Lead and mentor a team of medical affairs professionals across the region (future).

Posted 2 months ago

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🔥 Senior Clinical Data Manager

Posted 4 months ago

📍 United States, Canada

🧭 Full-Time

🔍 Biotechnology

🔧 Requirements

University degree required within a relevant discipline – Life Sciences experience is a plus
Comprehensive understanding of DM related systems, technologies and standards
Comprehensive knowledge of drug development and clinical research processes, GCP guidelines and regulations related to clinical data management
Self-motivated and able to work autonomously as well as within a high-functioning and collaborative team environment
Highly organized and detail-oriented
Strong verbal and written communication skills with the ability to build relationships internally and with external partners
Highest levels of professionalism, confidence, personal values and ethical standards

💡 Responsibilities

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.
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.
Accountable for ensuring data quality and timeliness of DM deliverables are met and align with company goals
Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the Trial Master File
Other related duties as may be determined or assigned

Data AnalysisGCPComplianceData management

Posted 4 months ago

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