Projektmanager*in (w/m/d) - Gentherapie-Entwicklung
Core
Coordinate the development program for an optical cochlea implant system combining optogenetics and gene therapy to restore hearing in patients with severe hearing loss.
Role type
Senior Project Manager (Biopharma/Gene Therapy)
Builds
Optical cochlea implant system (optogenetic gene therapy)
Domain
Biotechnology / Gene Therapy / Auditory Neuroscience
Required skills
Project/Program Management, Biopharmaceutical Development, Preclinical Study Coordination, Vendor/CRO Management, Regulatory Submission Preparation, Process Development (CMC)
Preferred skills
Gene Therapy, Viral Vectors, ATMPs, Multidisciplinary Team Leadership
Technologies
AAV, Optogenetics, GMP manufacturing
Responsibilities
Plan and coordinate cross-functional development activities and maintain project plans/milestones; Coordinate AAV production and CMC activities including process development and GMP manufacturing; Manage preclinical studies (efficacy, safety, biodistribution, toxicology) with external CROs; Manage external partners and support supplier selection and contract negotiations; Support preparation for regulatory interactions and submissions.