Dianthustx
Director / Senior Director, Clinical Development Scientist New
Dianthustx, Baltimore, Maryland, United States
Overview
Remote Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn. Responsibilities
As the (Senior) Director, Clinical Development Scientist, you will lead the scientific aspects of global Phase III pivotal trials, ensuring that study design, execution, and interpretation are of the highest quality. Serve as scientific lead on assigned Phase III/late-stage trial(s): define protocol and endpoints, author or review regulatory-relevant documents, ensure protocol integrity and compliance Collaborate cross-functionally (clinical operations, biostatistics, regulatory, safety) to drive operational feasibility, site selection, study start-up, and execution across regions Oversee safety and efficacy data monitoring: identify trends, support medical monitoring, work with DSMBs/DMCs, ensure timely reporting and regulatory compliance Support and contribute to the development and refinement of the overall Clinical Development Plan and associated evidence generation strategy Maintain and apply knowledge of disease biology, competitive landscape, therapeutic modalities, and regulatory/scientific advancements relevant to the therapeutic area Facilitate external relationships: sites, investigators, KOLs, CROs, regulatory agencies Provide mentorship, guidance, and scientific oversight to team members on scientific content and trial execution Produce and support publications, presentations, and internal/external communications of trial findings and strategic insights Ability to travel 15-20% Qualifications
Advanced degree in life/health sciences (PhD, PharmD, MD, MPH or equivalent) Deep understanding of rare disease, neurology, immunology, or a closely related field Extensive knowledge of drug development processes (late-phase trials), GCP/ICH standards, clinical operations, study design, safety monitoring, and statistics Demonstrated experience drafting and reviewing protocols, regulatory documents, medical monitoring plans, safety reports, etc. Excellent scientific writing ability and meticulous attention to detail Strong skills in data review, trend identification, data interpretation, and safety oversight, including experience with DSMBs/DMCs or other safety governance Effective communication, both written and verbal, with ability to engage with internal teams, investigators, CROs, regulatory bodies, and external experts Strategic mindset with ability to balance long-term goals and tactical needs Experience working across geographies and multimodal teams; capable of influencing without direct authority Proficiency in tools commonly used in clinical development (e.g. Microsoft Office, EDC systems, data platforms)
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Remote Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn. Responsibilities
As the (Senior) Director, Clinical Development Scientist, you will lead the scientific aspects of global Phase III pivotal trials, ensuring that study design, execution, and interpretation are of the highest quality. Serve as scientific lead on assigned Phase III/late-stage trial(s): define protocol and endpoints, author or review regulatory-relevant documents, ensure protocol integrity and compliance Collaborate cross-functionally (clinical operations, biostatistics, regulatory, safety) to drive operational feasibility, site selection, study start-up, and execution across regions Oversee safety and efficacy data monitoring: identify trends, support medical monitoring, work with DSMBs/DMCs, ensure timely reporting and regulatory compliance Support and contribute to the development and refinement of the overall Clinical Development Plan and associated evidence generation strategy Maintain and apply knowledge of disease biology, competitive landscape, therapeutic modalities, and regulatory/scientific advancements relevant to the therapeutic area Facilitate external relationships: sites, investigators, KOLs, CROs, regulatory agencies Provide mentorship, guidance, and scientific oversight to team members on scientific content and trial execution Produce and support publications, presentations, and internal/external communications of trial findings and strategic insights Ability to travel 15-20% Qualifications
Advanced degree in life/health sciences (PhD, PharmD, MD, MPH or equivalent) Deep understanding of rare disease, neurology, immunology, or a closely related field Extensive knowledge of drug development processes (late-phase trials), GCP/ICH standards, clinical operations, study design, safety monitoring, and statistics Demonstrated experience drafting and reviewing protocols, regulatory documents, medical monitoring plans, safety reports, etc. Excellent scientific writing ability and meticulous attention to detail Strong skills in data review, trend identification, data interpretation, and safety oversight, including experience with DSMBs/DMCs or other safety governance Effective communication, both written and verbal, with ability to engage with internal teams, investigators, CROs, regulatory bodies, and external experts Strategic mindset with ability to balance long-term goals and tactical needs Experience working across geographies and multimodal teams; capable of influencing without direct authority Proficiency in tools commonly used in clinical development (e.g. Microsoft Office, EDC systems, data platforms)
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