Clinical Development Lead

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 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.

Key Responsibilities

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.

·      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 & Qualifications

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.

·      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.