Dianosic is a deeptech, clinical-stage start-up developing transformative intranasal formulations of well-established active pharmaceutical ingredients to unlock new therapeutic potential and improve patient outcomes. This role is central to advancing our next-generation formulation and drug-delivery system into clinical development.
We are seeking an experienced Clinical Development Lead with a strong background in early-stage drug development to drive the scientific and strategic direction of our first-in-human and Phase I/II programs. While the role includes oversight of clinical operations, its core focus is clinical development leadership, integrating medical, scientific, and operational perspectives to advance novel intranasal and N2B therapies.
You will serve as the clinical development cornerstone for the ARIS platform, shaping study designs, guiding translational strategy, ensuring scientific integrity, and steering cross-functional decision-making. This role plays a key part in translational and preclinical strategy to ensure seamless progression from animal models to human studies — particularly for N2B delivery.
You will work cross-functionally with R&D, Regulatory, CMC, external partners, CROs, and academic collaborators, shaping both the operational and scientific foundations of our CNS programs.
Clinical Development Strategy & Leadership
· Define and refine clinical development strategies for our product platform in CNS.
· Design and lead early-stage clinical development plans, integrating scientific, operational, and regulatory components.
· Drive innovation in trial design and leverage existing data to streamline development timelines.
· Lead full clinical operations for Phase I/II studies, from protocol design to study close-out.
· Oversee CRO and vendor selection, contracting, and performance oversight.
· Manage study timelines, budgets, and operational plans, ensuring high-quality execution.
· Contribute to data interpretation and translational modelling for dose selection and delivery parameters.
· Participate in preclinical N2B study planning (PK/PD, biodistribution, neurotoxicity, behavioral endpoints).
· Ensure alignment between preclinical evidence packages and clinical development needs.
· Clinical Development Expertise
· Advanced degree in Life Sciences, Pharmacy, Neuroscience, or related field (PharmD, MSc, PhD, MD).
· Minimum 5 years of experience in early-stage clinical development.
· Demonstrated ability to interpret clinical safety and efficacy data.
· Working knowledge of translational research approaches bridging nonclinical and clinical development.
· Proven experience managing Phase I/II studies, including hands-on protocol development.
· Experience authoring key clinical documentation and managing TMF-quality standards.
Fluent in English; French is a strong plus.
A unique opportunity to shape the first clinical development plan for a novel N2B formulation and drug-delivery platform.
· Exposure to high-impact partnerships with CROs, CDMOs, academic labs, and pharmaceutical companies.
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