About Us

About the Role

As the Senior Accountant you will have a direct impact on accounting and reporting activities for a fast-growing, public biotech.

Reporting to the Director, Accounting, you will be responsible for (i) assisting with monthly and quarterly close activities such as preparation of journal entries, reconciliations, financial analyses, supporting documentation and financial statements, (ii) assisting with systems implementations, including potential new ERP, (iii) assisting with management and execution of our independent audit and Sarbanes-Oxley activities, and (iv) supporting other activities such as clinical trial accruals and collaboration arrangements. You must have experience working with public biopharma companies and/or public accounting experience to be successful in this role.

This is an exciting opportunity to assist with the continued build-out of the accounting and financial reporting processes and have a significant impact on the future success of the company. 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.

Key Responsibilities

• Complete monthly and quarterly account reconciliations to ensure accurate reporting and ledger maintenance including but not limited to cash, accounts receivable, accounts payable, general ledger, fixed assets, payroll, prepaids, and purchasing.
• Assists with the Sarbanes-Oxley activities including updating system documentation, testing controls, remediating control deficiencies and coordination efforts with the auditors.
• Assists with completion of audit requests related to the annual audit and quarterly reviews.
• Assists with the implementation of accounting systems, policies, and procedures.
• Keeps up to date on overall activities of the team, identifying problem areas and taking corrective actions.
• Prepares specialized analyses in support of all business functions.
• Potential management of future team members including but not limited to activities of mentoring, training and embodying a continuous improvement mindset.
• Assists with specific projects and initiatives unique to a fast-growing biotechnology start-up, such as system implementations, updates and business process improvements and other ad hoc projects.

Experience

• CPA or CMA license preferred.
• Bachelor’s degree (B.A.) or equivalent.
• At least 5 years of related experience and/or training with 1-2 years of biotechnology or life science industry experience required.
• Working knowledge of all aspects of accounting and financial reporting.
• Flexible, personable team-player, comfortable in a fast-paced, small company environment.
• Ability to identify errors and root causes of errors, develop workable solutions or alternatives.
• Ability to work with all levels of management.
• Strong organizational, problem-solving, and analytical skills; able to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.

About Us

About the Role

As the Associate Director, Pharmacovigilance, you will work closely with the Safety team to support ongoing clinical trials.

This role is critical in ensuring patient safety and regulatory compliance throughout the drug development lifecycle. Day to day, you will work closely with safety physicians, clinical teams, and external stakeholders to manage safety data and contribute to safety oversight. You must have experience reviewing adverse events, safety signals, and coordinate/contribute to the Safety Review Committee (SRC) and Drug Safety Monitoring Boards (DSMB) meetings. You must have experience supporting clinical pharmacovigilance activities and working with DSMBs in order to be successful in this role.

This is a unique role that will allow you to work collaboratively with the growing pharmacovigilance team that is working closely with cross functional teams to help Dianthus 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 within the United States.

Key Responsibilities

Safety Data Review

• Oversee pharmacovigilance activities for assigned clinical programs, ensuring alignment with global regulatory requirements and internal SOPs.
• Review, evaluate, and provide managerial oversight of adverse event (AE) reports, including serious adverse events (SAEs), ensuring accurate assessment and timely submission to regulatory authorities and ethics committees.
• Ensure quality and accuracy of safety data review within the safety database and direct reconciliation efforts with clinical databases to maintain data integrity.

Cross-functional Communication & Collaboration

• Contribute to the development of safety sections within clinical documents, including protocols, investigator brochures, and clinical study reports.
• Manage and oversee the scheduling, planning, and facilitation of DSMB and SRC meetings, including preparation of agendas, meeting materials, guided discussions, documentation of minutes, and follow-up on action items.
• Contribute strategically to the preparation of aggregate safety reports such as the DSUR.
• Partner with safety physicians on signal detection, emerging safety issues, risk assessments, and benefit–risk evaluations.
• Serve as a subject matter expert to internal stakeholders and external partners on safety-related topics, providing guidance and ensuring consistent communication.

Documentation & Compliance

• Ensure organizational compliance with global pharmacovigilance regulations (FDA, EMA, ICH) and company policies.
• Manage and oversee pharmacovigilance-related quality events, including change controls, deviations, and CAPAs, ensuring timely resolution and documentation.
• Supervise and ensure accurate documentation of DSMB and SRC meetings and maintain records within designated systems and repositories.

Experience

• Education: PharmD or RN degree required.
• Experience in pharmacovigilance or in clinical development within biotech or pharmaceutical industry.
• Proven experience reviewing adverse events and working closely with safety physicians.
• Hands-on experience supporting DSMBs and SRCs and preparing safety deliverables.
• Proficiency in Microsoft Office Suite and Microsoft Teams, with the ability to leverage these tools for efficient communication, scheduling, and documentation
• Strong knowledge of global PV regulations (FDA, EMA, ICH guidelines).
• Excellent analytical, organizational, and communication skills.
• Ability to thrive in a fast-paced, start-up environment and manage multiple priorities.
• Fluency with Argus safety database
• Familiarity with rare disease or oncology programs.
• Prior experience in a start-up or small biotech setting.

About Us

About the Role

The Associate Director, Regulatory CMC, will execute global regulatory CMC strategies in collaboration with key stakeholders.

Reporting to the Vice President, Regulatory CMC, you will provide expert guidance to manufacturing and quality teams, lead global regulatory submissions, act as primary liaison with Health Authorities for CMC aspects of programs, and interpret applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance, and contribute to department initiatives. You must have experience with biologics, specifically monoclonal antibodies, bispecifics, and / or fusion proteins or vaccines in order to be successful in this role.

This is a unique opportunity to join a growing organization with an expanding pipeline and play an integral role in the creation and implementation of regulatory strategies from early development through marketing approval. 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.

Key Responsibilities

• Provide leadership and strategic direction for regulatory CMC deliverables, including drug/device combination products.
• Identify, communicate, and propose resolutions to routine and complex strategic issues.
• Lead planning and provide hands on support for development, and on-time delivery of clear and effective global CMC regulatory submission documents.
• Act as primary contact with Health Authorities for CMC-related matters; lead preparation for and conduct of agency meetings.
• Maintain expert knowledge in US and international biopharmaceutical and combination product regulations and provide proactive regulatory intelligence.
• Review and provide regulatory assessments on change controls.
• Identify regulatory opportunities and risks and communicate them to project teams and senior management in a clear and concise manner.
• Provide regulatory advice and make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
• Identify, engage and collaborate with external regulatory experts and consultants.
• Support departmental initiatives, including process and infrastructure development, budgeting, and authoring of departmental documents, such as SOPs and Regulatory Development Plans.

Experience

• Bachelor's degree and a minimum of 8 years of experience in Regulatory CMC for biotherapeutics, biologics experience required; drug/device combination product experience a plus.
• Demonstrated track record of successful interactions with FDA and other Health Authorities related to CMC submissions.
• Expert understanding of scientific principles and regulatory CMC requirements relevant to global drug development.
• Preparation of Quality sections of regulatory dossiers, including IND/CTA/IMPDs, briefing documents, and BLA/MAAs.
• Preparation for and conduct of Regulatory CMC meetings with global Health Authorities for complex issues.
• Strong interpersonal skills and the ability to collaborate effectively with technical area 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.

About Us

About the Role

The Senior Medical Director, Clinical Development will be the clinical and medical strategic lead of one or more clinical trials for DNTH212.

Reporting to the SVP, Clinical Development, you will steer the preparation, review and execution of clinical study synopses and protocols, investigator brochures, and clinical study reports; review SAPs and TLF shells, guide the evaluation of emerging clinical trial data, oversee/guide the data interpretation and data mining, and ensure assigned studies are conducted according to GCPs and SOPs. You will act as a the medical monitor in close collaboration with the CRO medical and clinical monitors, ensure timely recruitment in collaboration with clinical operations, oversee/guide in conducting literature searches and reviews, meta-analyses, and publishing data. You must have experience with Rare Diseases or Rheumatology within the biotechnology or pharmaceutical industries.  

This is a unique opportunity to join a growing organization with an expanding pipeline and lead clinical strategy for auto-immune indications. 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.

Key Responsibilities

• Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program.
• Leading development of clinical sections of trial and program level regulatory documents.
• Driving execution of the program and/or clinical trial in partnership.
• Supporting the Senior Vice President, Clinical Development by providing medical input into Clinical Development Plan (CDP) and Clinical Trial Protocol (CTP) reviews and contributing to/driving development of disease clinical standards for new disease areas.
• Literature review, KOL interactions, attending scientific meetings, and presenting the clinical development plan to the relevant internal stakeholders to help shape the new indication selection process.
• Leading the protocol development for the new selected indication/s, working closely with the relevant external and internal stakeholders.
• As a medical specialist, supporting and leading interactions with external and internal partners and decision boards.
• Medical monitoring of the assigned clinical trial/s, data and safety review and working closely with the clinical operations, and external partners to oversee conduct of the assigned clinical trial/s.
• Working closely with the internal and external stakeholders as well as the clinical sites, and investigators to help ensure timely recruitment.

Experience

• MD with board certification in US, with clinical experience in Immunology or Rheumatology.
• 8+ years of previous experience in clinical research in the CRO/ biotech/ pharma setting preferred. Experience in rare diseases, neurology is highly preferred.
• Proven ability to work with cross functional teams, study vendors and clinical trial sites.
• Strong business communication skills, written and verbal, and comfortable with giving presentations internally and externally.
• Knowledge – thorough understanding of GCP/regulatory requirements.
• Proactiveness – the ability to identify challenges and risks and implement appropriate actions with some supervision.
• Motivation – highly motivated and self-starter; able to organize and perform complex tasks with minimal supervision.
• Collaboration – to coordinate activities of internal cross-functional study team as well as external vendors as applicable.
• Open-mindedness – listen to ideas from others and seek guidance when applicable; inform manager as situations arise to brainstorm and seek best solutions.

About Us

About the Role

The Senior Manager / Associate Director, Centralized Monitoring will play a critical role in ensuring the integrity, accuracy, and completeness of clinical trial data.

You will support bringing the central data review process in-house from the CRO, oversee data review activities across multiple studies, work closely with CRO Clinical Study Teams, and internal cross-functional teams to ensure high-quality data that supports regulatory submissions and scientific publications. You must have extensive experience as a CRA and ideally a healthcare background in order to be successful in this role.

This is an exciting opportunity to be a part of a high profile team building our internal data review processes to ensure alignment across the development teams. 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.

Key Responsibilities

• Lead and manage clinical data review activities across assigned studies.
• Actively participate in data review and protocol deviation review meetings.
• Collaborate with CROs to oversee data cleaning, query resolution, and database lock processes.
• Review clinical data, data listings, and reports to identify inconsistencies, trends, and potential issues.
• Identify, assess, and escalate data anomalies and protocol deviations.
• Partner with Clinical Development Operations, Clinical Development, Data Management, and Biostatistics to ensure data quality and compliance.
• Develop and implement data review plans and contribute to data management plans.
• Support Data Management activities (e.g., CRF design, User Acceptance Testing)
• Participate in CRO oversight, including performance monitoring and issue resolution.
• Support audit readiness and regulatory inspections by ensuring data traceability and documentation.
• Mentor junior team members and contribute to process improvement initiatives.

Experience

• Minimum of 5 years of experience in clinical research, including experience as a Sr. Clinical Research Associate (CRA), Lead CRA, or in a data oversight role. Registered Nurse (RN), or equivalent clinical/medical background (e.g., MD, PA, study coordinator) preferred.
• Strong understanding of clinical trial processes, GCP, and global regulatory requirements.
• Experience working with CROs and managing outsourced data review activities.
• Proficiency in reviewing EDC systems and clinical data listings. [Experience with targeted source data verification (tSDV) strongly preferred.]
• Excellent analytical, critical thinking, organizational, and communication skills.
• Experience with process improvement initiatives (e.g., process revision, plan development, SOP development, etc.)
• Ability to work independently in a fast-paced, startup environment.

About Us

About the Role

BioPharma Experience is required.

We are seeking a strategic, creative, and execution-oriented ED / VP, Corporate & Internal Communications to build and lead a modern, high-impact communications function in a fast-growing biotech company.

This role sits at the intersection of people, corporate brand, and business strategy—responsible for shaping how we communicate internally and externally, strengthening employee engagement, elevating our corporate brand, and ensuring a consistent and compelling company narrative across all audiences, while operating as predominantly a remote company.

You will serve as a trusted advisor to senior leadership and partner closely with the VP of Marketing and VP of Investor Relations to ensure alignment across corporate and internal communications. 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 - within the contiguous United States. 

Key Responsibilities

Corporate Communications

• Lead the redesign and ongoing evolution of the company’s external website to reflect brand, strategy, and scientific innovation.
• Ensure the website serves as a best-in-class platform for storytelling, recruiting, investor visibility, and patient education and engagement.

Internal Communications & Employee Experience

• Develop and implement a forward-thinking internal communications strategy aligned with the company’s mission, vision, and values.
• Design and execute a comprehensive internal communications approach for a fully remote workforce that drives engagement, clarity, and connection.
• Create and manage a dynamic, year-round internal communications and employer brand calendar that proactively aligns messaging with business priorities, milestones, and organizational needs.
• Oversee all internal communication channels to ensure employees are informed, engaged, and connected.
• Direct the production, content strategy, and ongoing evolution of the company’s employee intranet as a central hub for culture, information, and collaboration.

Executive & Leadership Communications

• Craft and deliver executive communications that reflect leadership voice, company values, and business priorities.
• Ensure consistency of tone and messaging across all employee-facing forums, including town halls, company updates, and enterprise-wide communications.
• Anticipate communication needs throughout the year and proactively prepare executive messaging aligned with key business moments.
• Partner with Finance, Investor Relations, and Business Development to support executive communications and to ensure consistent messaging aligned with company news releases

Corporate Brand Elevation

• Enhance and update our corporate brand image via refresh of look and feel, taglines, and corporate narrative to reflect position as an innovative, late-stage biotech company
• Build and elevate the company’s employer brand through innovative, authentic, and data-driven social media campaigns.
• Partner with Talent and Marketing to position the company as a destination for top biotech talent.
• Oversee content strategy and storytelling across external platforms, including LinkedIn, careers pages, and employee-generated content.
• Plan and execute social media content with a focus on LinkedIn to raise Dianthus’ visibility, highlight our commitment to patients, spotlight employees and our science, recognize corporate achievements, and support recruiting initiatives.

All-Company Meetings & Events

• Own the agenda development, narrative, and content management for biannual all-company meetings and regular virtual town hall meetings.
• Partner with senior leadership to craft compelling presentations and storytelling.
• Ensure meetings are engaging, informative, and reinforce company strategy, culture, and priorities.

Experience

• 10+ years of progressive experience in communications, including leadership roles in biotech and/or pharma
• Proven experience leading major communications initiatives, including:
• Website redesign and digital content strategy
• Internal communications in remote or distributed organizations
• Corporate brand development and social media campaigns
• Executive and leadership communications
• Strong executive presence with experience advising senior leaders and influencing at the highest levels of the organization.
• Exceptional writing, storytelling, and content strategy skills, with the ability to translate complex scientific information into clear, compelling narratives.
• Demonstrated ability to balance strategic thinking with hands-on execution.
• Experience working cross-functionally with Marketing, HR/People, Investor Relations, Finance, and Clinical/Medical Affairs teams.
• Strong project management and organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• Data-driven mindset with experience establishing and tracking communication effectiveness metrics.

What Success Looks Like

• A cohesive, compelling company narrative consistently reflected across internal and external channels.
• A modern, high-performing website that supports brand, recruiting, investor engagement, and patient connection.
• An engaged, informed, connected, and aligned remote workforce.
• Strong, authentic leadership communication that builds trust and clarity.
• A differentiated employer brand that attracts top-tier talent.
• High-impact all-company meetings and town halls that energize and align employees.

About Us

About the Role

The Director, Clinical Quality Assurance (QA), will be responsible for end-to-end quality oversight of global clinical trials to ensure compliance with applicable regulatory requirements and internal standards.

Reporting to the Sr. Director, Clinical QA, you will provide independent quality oversight of clinical development programs, ensuring that clinical trial conduct, data integrity, and sponsor oversight activities meet expectations of global regulatory authorities (e.g. ICH, FDA, EMA, MHRA, etc.)

You will partner cross-functionally with Clinical Operations, Clinical Development, Data Management, Pharmacovigilance, Bioanalytical, CMC, and Regulatory Affairs teams, while working closely with other functions of the Quality Unit (e.g. Clinical Quality Systems and Quality Systems and Compliance) to ensure the global GCPs are met for our clinical studies and to support inspection readiness and quality system alignment. Your role will be integral in assuring Dianthus is always inspection ready. You must possess experience and skill collaborating and influencing CRO’s, laboratories, and other clinical vendors in order to be successful in this role.

This is a unique opportunity to join a rapidly growing organization and have a significant impact at Dianthus. 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.

Key Responsibilities

• Provide proactive, risk-based quality oversight for global clinical trials across all phases (e.g. Phase I, II, and III).
• Serve as the primary QA lead for clinical development programs, ensuring quality is embedded from study design through close-out.
• Ensure compliance with ICH E6 (R3) GCP and applicable global regulations (e.g. FDA, EMA, MHRA, etc.)
• Provide expert guidance on quality risk management, issue escalation, and mitigation strategies.
• Establish and maintain robust sponsor oversight frameworks for CROs and other third-party vendors.
• Ensure effective oversight of delegated activities, including monitoring, data management, and safety management.
• Collaborate with the Quality Unit to assess vendor qualification, performance metrics, and compliance trends.
• Lead and execute a risk-based GCP audit program, including investigator site audits, clinical vendor/CRO audits, and clinical process/system audits.
• Align audit strategy with clinical milestones and BLA readiness.
• Oversee audit findings, CAPAs, and effectiveness checks, ensuring timely and sustainable resolution.
• Ensure data integrity principles (ALCOA++) are embedded across clinical programs.
• Partner with the Director/Sr. Director of Clinical Quality Systems and the Sr. Director of Quality Systems and Compliance to support inspection readiness activities, provide audit insights and risk signals, contribute to inspection strategy and preparation.
• Participate in regulatory inspections as a QA subject matter expert.
• Act as a trusted advisor to Clinical Development and Operations leadership.
• Drive a culture of quality, compliance, and continuous improvement.
• Provide QA input and conduct QC of protocols, amendments, CSRs, and regulatory submission components.
• Provide quality oversight of bioanalytical activities, including review of bioanalytical method validation documentation to ensure alignment with regulatory expectations and clinical program needs.
• Lead or contribute to quality governance forums and risk review boards.
• Identify and assess systemic quality risks and compliance gaps
• Ensure appropriate classification and management of protocol deviations, serious breaches, and inspection findings.
• Escalate critical risks to senior leadership with clear, risk-based recommendations.
• Additional duties may be identified by functional management based on current project/business objectives.
• Some travel (approx. 20%) is required for company meetings and support of audits or regulatory inspections (e.g. in support of Sr. Director Quality Compliance as needed).

Experience

• BS or MS degree in life sciences or related field required.
• 12+ years of experience in GxP with minimum of 5+ years in GCP within the biotech or pharmaceutical industry.
• Deep knowledge of GCP regulations and guidance’s (e.g. ICH, FDA, EMA, MHRA, etc.)
• Significant experience supporting global clinical trials (e.g. Phase I, II and III).
• Demonstrated experience supporting or leading submissions and regulatory inspections (e.g. BLA, PMA, BIMO).
• Deep expertise of Sponsor oversight and CRO/vendor management responsibilities.
• Deep expertise in data integrity principles and risk-based quality management.
• Demonstrated experience in clinical audit strategies including investigator site audits, audit execution, and CAPA management.
• Experience working with or managing eQMS platforms and quality processes.
• Knowledge of Clinical Quality Systems.
• Experience with project management processes / tools to support in meetings, assist with project planning, and facilitate completion of tasks.
• Proven ability to lead strategically while remaining hands-on in a fast-paced biotech environment and risk-based thinking is critical.
• Proven capability to drive alignment and influence stakeholders across global, cross-functional organizations.
• Ability to translate regulatory expectations into practice, risk-based solutions.
• Excellent communication skills with the ability to engage senior leadership and regulatory inspectors.

About Us

About the Role

We are building our Clinical team and need two Senior Clinical Trail Associates who are open to owning end-to-end processes. You will report directly to the respective Senior Director, Clinical Development Operations global leads.

As the Senior Clinical Trial Associate (Sr. CTA)/ Sr. Associate, you will play a crucial role in the Clinical Development Operations (CDO) department to support the planning, execution, and management of clinical trials in accordance with regulatory requirements and industry best practices.  In this role, you will collaborate with cross functional study teams, clinical Research Organizations (CROs), and other external vendors to ensure the successful delivery of clinical study activities.

You must have experience supporting global clinical study teams in order to be successful. Experience in rare diseases is ideal, however not required. We are looking for someone who can grow with our organization and will continue to support your ongoing 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.

Key Responsibilities

• Provides support to assigned clinical studies, taking on various responsibilities to support project and study deliverables.
• Coordinates, attends and may lead study team meetings; ensures appropriate meeting scheduling and documentation, including creation, distribution and filing of meeting agendas and minutes.
• Maintains and generates applicable study trackers and documents (for example: action-decision log, storyboard, patient enrollment and IRB approvals).
• Monitors clinical trial insurance and license agreements across studies and work with vendors to ensure current agreements.
• Supports the development and review of study documents, including study manuals.
• Maintains knowledge and acts as team super-user or subject matter expert for study-related systems and processes.
• Manages deliverables and navigates changing priorities.
• Supports the clinical team with coordination and preparation for investigator meetings, PI calls, conferences as well as internal clinical meetings.
• Supports management of the Trial Master File according to Sponsor Oversight plan to ensure accuracy and completeness.
• Assists with study budget oversight, including invoice tracking, reconciliation and collaboration with cross-functional teams and vendors.
• Participates in vendor selection and management meetings (e.g., CROs, IVRS, Central Labs, etc).

Experience

• BA/BS degree or equivalent, relevant work experience.
• Minimum of 5 years’ experience working on clinical studies in pharmaceutical, biotech, or CRO setting preferred. Prior CTA experience required.
• Excellent interpersonal and communication skills with ability to work collaboratively across functional teams.
• Strong organizational and time management skills, and strong attention to detail.
• Knowledge of global regulatory and compliance requirements for clinical research.
• Experience with essential documentation for Trial Master Files required.
• Knowledge of drug development, clinical operation processes, medical terminology, and procedures according to FDA GCP/ICH regulatory guidelines.
• Excellence with MS Office products Word, Excel, SharePoint, PowerPoint.
• Experience working with clinical trial systems (CTMS, IRT, EDC) preferred.