Dianthus Therapeutics is a clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency over existing complement therapies. Based in New York City and Waltham, Mass. Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the next generation of antibody complement therapeutics to deliver transformative medicines for patients with severe autoimmune diseases.
Since raising a $100M Series A in April 2022 co-led by 5AM Ventures, Avidity Partners, and Fidelity Management & Research Company, with participation from additional investors including Wedbush Healthcare Partners and founding investors Fairmount, Tellus BioVentures, and Venrock Healthcare Capital Partners, Dianthus continues to make progress in advancing its lead monoclonal antibody, DNTH103.
On May 3rd, 2023, Dianthus announced it entered into a reverse merger transaction with Magenta Therapeutics, a publicly traded biotech company, to create a new public company with the sole focus on advancing Dianthus’ pipeline of next generation complement therapies. In support of the merger, Dianthus has secured commitments for a $70 million private investment in its common stock and pre-funded warrants from a syndicate of healthcare investors led by Fidelity Management & Research Company, Catalio Capital Management, 5AM Ventures, Avidity Partners, Wedbush Healthcare Partners and founding investors Fairmount, Tellus BioVentures and Venrock Healthcare Capital Partners, that is expected to close immediately prior to completion of the merger. With the cash expected from both companies at closing and the proceeds of the concurrent private financing, the combined company is expected to have approximately $180 million of cash or cash equivalents immediately post-closing.
Dianthus has a steady cadence of milestones with DNTH103 including top line Phase 1 data aiming to confirm potent classical pathway inhibition and favorable, extended PK expected by the end of 2023, initiation of planned Phase 2 trial in generalized Myasthenia Gravis expected in Q1 2024 followed by two additional planned Phase 2 trial initiations in other neuro indications, and planned initiation of an open label proof of efficacy trial in Cold Agglutinin Disease with patient data expected in 2H 2024.
About the Role
The Director / Senior Director, Bioanalytical Sciences will be responsible for developing and executing bioanalytical and biomarker strategies to support preclinical and clinical studies of novel drug candidates.
You will initially report to the Chief Medical Officer and provide strategic leadership, scientific and technical expertise in protein biologics assay development, optimization, and qualification/validation. You will be responsible for supporting nonclinical and clinical drug development programs directly impacting our pipeline. Day to day you will work with and build strong collaborations with external contract research organizations (CROs.), serve as a key member of the project team, collaborating with other functional areas to ensure the timely and successful development of drug candidates. You will be responsible for successful delivery of a program from nonclinical to clinical development and successful delivery of Phase 1-3 clinical results. You must have experience measuring large molecules in biological matrices to be successful in this role.
This is an exciting opportunity to join a small, clinical-stage biotech company and have a significant impact on our success. 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.
- PhD in biochemistry, immunology, pharmacology, or other relevant scientific discipline.
- Demonstrated experience in bioanalytical assay development and execution in the pharmaceutical / biotechnology industry, with a focus on PK, PD, ADA and biomarker assay development. Experience in complement assay development a plus.
- Leadership experience with establishment and/or oversight of a GxP laboratory for evaluation of biologic therapeutic candidates.
- Experience with global outsourcing/CRO management
- Strong knowledge of PK/PD principles and their application to drug development.
- Experience with GxP compliance requirements and FDA regulatory guidelines as applicable in support of biologics drug development programs. Working knowledge of quality systems and regulatory requirements with experience in preparing and defending regulatory filings.
- Experience with writing/reviewing successful regulatory submissions.
- Successful delivery of a Phases 1, 2, & 3 clinical study program
- Strong project management skills
- Excellent communication, writing and presentation skills, with the ability to communicate data clearly and concisely to project teams, senior management, and external stakeholders.
- Demonstrated ability to work effectively in a fast-paced, collaborative, and dynamic environment.
- Provide leadership and accountability for execution of overarching strategies for developing, optimizing, and qualifying/validating bioanalytical and biomarker assays to support the development of antibody therapeutic candidates.
- Conceive, implement, manage, and analyze a diverse range of bioanalytical and biological testing (including measurement of drug concentrations and anti-drug antibodies, as well as biomarkers) for novel, complex biotherapeutic drug candidates in support of nonclinical and clinical development.
- Ensure thorough CRO evaluation, selection, and management, including vendor audits, personnel training, and troubleshooting/investigations as needed for transfer of bioanalytical methods.
- Coordinate and manage network of CROs for study development and execution.
- Support drafting of regulatory filings in collaboration with Program Leadership and Regulatory.
- Collaborate with other functional areas to ensure the timely and successful development of drug candidates.
- Manage resources and budgets to support the development of PK/PD assays and the interpretation and reporting of PK/PD data.
- Ensure compliance with all relevant regulations, guidelines, and standards for bioanalytical assays.
- Communicate PK/PD data to project teams, senior management, and external stakeholders in a clear and concise manner.
- Evaluate new technologies and approaches to improve PK/PD assay development and execution.