R&D Pharmaceutical Development Lead (H/F/X)

Pharmaceutical Development Strategy Contribute to the definition and execution of pharmaceutical development strategies for Aquilon's pipeline products: Design robust and scalable pharmaceutical formulations suitable for non-clinical assessments, clinical and future commercial development. Provide scientific guidance for the development of drug-device combinations for inhalation or nasal delivery. Guide trouble-shooting activities to develop formulations in line with Aquilon's objectives and regulatory requirements. Participate in the definition of Target Product Profiles (TPP) and development strategies. Ensure alignment between formulation development, manufacturing processes, analytical characterization and clinical requirements (a.o., PK/PD data and clinical study objectives). Organize technology transfer activities with external manufacturing partners. The role ensures coordination and scientific oversight of pharmaceutical development activities from laboratory development to clinical manufacturing stages taking into account regulatory requirements. CMC Scientific Support Provide scientific input for Chemistry, Manufacturing and Controls (CMC) activities across projects. Contribute to the design and review of pharmaceutical development plans, protocols and reports. Support preparation and review of regulatory documentation (IMPD, IND, CTD modules, briefing packages). Ensure regulatory consistency of pharmaceutical development activities with applicable guidelines (ICH, GMP, GLP). Scientific Analysis and Decision Support Analyze experimental and clinical data to support strategic decision-making. Provide scientific recommendations for project orientation and optimization. Maintain awareness of scientific advances in pulmonary drug delivery, formulation technologies, and clinical development. Conduct literature reviews and scientific monitoring of the therapeutic area. Project Leadership and Coordination Particip

Assurance groupe | Chèque-repas | Outil informatique

Aquilon develops pharmaceutical formulations for inhalation and nasal administration and aims to translate innovative technologies into clinical-stage products.