publiée le 21 / 06 / 2022
Dianosic was founded in 2017 and develops innovative solutions in the field of ENT (Ear, Nose & Throat), a €50 billion, double digit growth, and still largely underserved market.
Our startup operates right at the frontier between Pharma and Medtech, as we see tremendous opportunities for drug-device combinations in this specialty. The project originates from the ENT Department from the University Hospital of Strasbourg, where unmet clinical needs have been identified.
Our main focus areas are Chronic Rhinitis, Chronic Sinusitis and intranasal bleeding (Epistaxis). Noteworthy, Dianosic has a strong French and German footprint in R&D and manufacturing.
Dianosic’s strategic goal is to establish new standards of care in Chronic Rhinitis and Chronic Sinusitis with its drug-eluting Active Resorbable Scaffold (ARIS). This drug-device combination ARIS platform, developed with world renowned resorbable polymers experts, has the potential to establish new treatment paradigms. Moreover, our ARIS platform creates immense opportunities to create other verticals, especially in the field of otology, chronic migraine and facial pain.
Given the increasing importance of our pharmaceutical activities, DIANOSIC is actively engaged in seeking and finding the right candidate in order to push CMC Regulatory activities forward in a timely fashion.
Last, dianosic acknowledges that ESG (Environmental, Social and Governance) topics are of utmost importance and takes all necessary actions to ensure they are properly factored in our strategic roadmap.
ROLES & RESPONSIBILITIES
Partner with other members of the company on overall strategic planning. Represent the company and its programs to external audiences.
Develop robust CMC Regulatory strategies and oversee planning and execution for both applications (chronic rhinitis and chronic sinusitis) of the Active Resorbable Intranasal Scaffold (ARIS) technological platform.
Provide subject matter expertise in relevant areas including the mastery of Regulatory changes through new guidelines or position statements from decision makers.
Present regular updates to the members of the company and relevant strategic boards.
Lead the CMC aspect of Drugs and drug device combination Research and Development (R&D) up to marketing approval in EU and USA; Support the Design and Development (D&D) of medical devices as and when needed.
Manage the Industrial manufacturing, distribution, and surveillance of marketed Drugs.
Coordinate the CMC section of Quality Management System.
Plan, execute and manages CDMOs and CMOs audits, selection, and qualification
Propose and manage budgets and resources required for: the clinical development, medical affairs. Participate to budget discussions and preparation for Regulatory Affairs activities.
Ensure effective policies and procedures are in place for respective areas of responsibility and compliance
Acts as Qualified Person (Responsible Pharmacist)
Work in close collaboration with Research & Development, Medical Devices, Regulatory Affairs, non-clinical and clinical internal / external experts.
Lead the CMC development strategy
Marketed products (drugs, drugs associated with dispensing devices)
Perform other duties as assigned.
High level education in pharmaceutical sciences (Master, Engineer, PharmD, PHD…)
10 years’ experience in the pharmaceutical industry (negotiable).
Basic computer sciences
Ability to travel
PACKAGE & KEY JOB FEATURES
Salary to be discussed based on individuals’ profiles
Training & development opportunities
Exposure to strategic topics (internally & externally)
Working conditions: flexible (office, remote or hybrid)
Philippe Bastide (CEO)