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Dianthus Therapeutics, Inc. · 3 months ago

Director / Senior Director, Clinical Development Scientist

Waltham, MA

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

Dianthus Therapeutics, Inc. is developing innovative therapies for severe autoimmune diseases. The Senior Director, Clinical Development Scientist will lead scientific aspects of global Phase III trials, providing leadership in protocol development and regulatory strategy to drive the progress of a novel therapeutic asset.

BiopharmaBiotechnologyHealth Care

Responsibilities

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 support 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%

Qualification

Clinical Development PlanPhase III trialsDrug development processesScientific writingData interpretationRegulatory documentsSafety monitoringEDC systemsEffective communicationMentorshipStrategic mindsetCross-functional collaborationAttention to detail

Required

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)