Clinical Operations Manager

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.

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.

·      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.

·      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

·      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.

·      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.

·      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.

·      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.

·      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.

·      Strong knowledge of ICH-GCP, EU/US regulatory frameworks, and CTA/IND processes.

·      Experience with drug–device combination requirements.

·      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.

·      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.