About Us
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.
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. 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 Senior Director, CMC Regulatory Affairs will develop and execute global regulatory CMC strategies in collaboration with key stakeholders.
Reporting to the Senior Vice President, Regulatory Affairs, you will provide 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.
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 10 years of experience in Regulatory CMC for biotherapeutics; drug/device combination product experience a plus
- Demonstrated track record of successful interactions with FDA and other Health Authorities related to CMC submissions, including marketing authorization(s)
- Expert understanding of scientific principles and regulatory CMC requirements relevant to global drug development
- Preparation of Quality sections of regulatory filings, 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
More About Us
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.
