Aquilon develops pharmaceutical formulations for inhalation and nasal administration and aims to translate innovative technologies into clinical-stage products.
The R&D Pharmaceutical Development Lead plays a key role in the design, coordination and scientific interpretation of pharmaceutical development activities at Aquilon.
This position combines galenic and or physicochemical (aerodynamics) expertise, pharmaceutical development strategy, and translational science to ensure the successful pharmaceutical development of innovative inhalation products, from early formulation development through non-clinical evaluation and clinical studies.
The role guides CMC strategy, formulation design, and drug-device combination development, and supports the design of non-clinical and clinical programs, ensuring consistency between pharmaceutical development, non-clinical data, and clinical objectives.
Key responsibilities:
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
- Participate in the scientific coordination of development programs with internal teams and external partners.
- Manage interactions with CROs, academic laboratories, bioanalytical laboratories and subcontractors.
- Organize and lead scientific and project meetings with internal teams and external collaborators.
- Contribute to planning, timelines, budget monitoring and project prioritization.
- Participate in risk management activities related to development programs.
Scientific Documentation and Communication
- Contribute to the preparation of:
- Development plans
- Study protocols
- Technical reports
- Grant applications
- Regulatory documents
- Participate in the preparation of scientific presentations for internal committees, advisory boards and partners.
- Support intellectual property strategy and scientific publications when appropriate.
Professional profile
Education
- PharmD, MSc or PhD in:
- Pharmaceutical Sciences
- Pharmaceutical Technology
- (Bio)Chemistry or related discipline
- A PharmD or industrial pharmacist qualification is strongly preferred.
Experience
- Experience in pharmaceutical development in the pharmaceutical or biotechnology industry.
- Experience in formulation development or drug delivery systems.
- Experience with inhalation or nasal drug delivery technologies is a strong asset.
- Experience in CMC activities and pharmaceutical regulatory documentation.
- Experience interacting with CROs and external partners.
Scientific Knowledge
Strong understanding of:
- Pharmaceutical formulation and galenic development
- Drug-device combinations
- Chemistry, Manufacturing and Control (CMC)
- Physicochemical properties of complex systems (aerodynamics would be an asset)
- Non-clinical drug development
- Basic clinical development principles
- PK/PD concepts
- ICH guidelines and regulatory requirements (EU and US).
Languages
- Fluency in English and French (written and spoken).
Key Competencies
Scientific Competencies
- Strong pharmaceutical development expertise
- Ability to integrate multidisciplinary scientific data
- Strategic thinking in drug development
- Analytical and problem-solving abilities
Leadership and Collaboration
- Excellent communication and scientific writing skills
- Ability to coordinate multidisciplinary teams
- Strong organizational and project management abilities
Ability to work with internal teams and external partners