About Dianosic
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. Our mission is to bring long-acting, cost-effective, safe, and patient-friendly therapies to the market.
Building on its proprietary intranasal insert platform, Dianosic is expanding from respiratory indications (chronic allergic rhinitis, chronic rhinosinusitis) into Nose-To-Brain (N2B) delivery for CNS diseases including schizophrenia and Parkinson's disease. This role is central to advancing our next-generation formulation and drug-delivery system into clinical development.
Role Overview
We are seeking an experienced Manager of Clinical Operations with strong expertise in early-stage drug development to lead our first-in-human and Phase I/II programs. Beyond clinical execution, 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.
Key ResponsibilitiesClinical 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.
· Provide strategic clinical input to advisory boards, KOL discussions, and key internal meetings.
Clinical Operations Execution
· 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.
· Ensure compliance with ICH-GCP, ISO 14155, MDR, and relevant EU/US regulatory expectations.
· Author/review essential study documentation: protocols, IBs, amendments, CSRs, ICFs, and patient-facing materials.
· Contribute to ongoing clinical activities in chronic allergic rhinitis
Translational & Preclinical Contribution
· Support the design of nonclinical studies needed for first-in-human trial authorization.
· 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.
· Knowledge of N2B administration pathways and translational methodologies is a strong asset.
Regulatory Interactions
· Prepare and contribute to IND/IMPD/CTA submissions and subsequent amendments in partnership with our CMC Director.
· Engage with EMA, FDA, and national authorities to support clinical program advancement.
· Understand regulatory frameworks for drug–device combinations in the EU and US.
Profile & QualificationsClinical 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.
· Strong knowledge of intranasal drug delivery and/or CNS or respiratory therapeutic areas.
· Demonstrated ability to interpret clinical safety and efficacy data.
· Understanding of clinical methodologies, statistical concepts, and trial design principles.
Translational & Preclinical Knowledge
· Working knowledge of translational research approaches bridging nonclinical and clinical development.
· Ability to contribute to nonclinical study design and dose-selection rationale.
· Familiarity with PK/PD modelling and biodistribution considerations in N2B delivery.
Clinical Operations Execution
· Proven experience managing Phase I/II studies, including hands-on protocol development.
· Strong track record of CRO/vendor oversight and operational delivery.
· Experience authoring key clinical documentation and managing TMF-quality standards.
Regulatory Competence
· Strong knowledge of ICH-GCP, EU/US regulatory frameworks, and CTA/IND processes.
· Experience with drug–device combination requirements.
Leadership & Soft Skills
· Entrepreneurial mindset and ability to thrive in a fast-paced start-up.
· Excellent communication skills with a collaborative, cross-functional leadership style.
· Strong analytical and problem-solving abilities.
· High adaptability, ownership, and forward-looking attitude.
· Fluent in English; French is a strong plus.
What We Offer
· A unique opportunity to shape the first clinical development plan for a novel N2B formulation and drug-delivery platform.
· A collaborative, agile environment bridging pharma, medtech, and neuroscience.
· Competitive compensation package.
· Exposure to high-impact partnerships with CROs, CDMOs, academic labs, and pharmaceutical companies.
· Significant growth potential as Dianosic scales its CNS programs globally.