Executive Director, Clinical Development

Executive Director, Clinical Development About the Company Innovative biotechnology (BioTech) company specializing in gene therapy for rare diseases IndustryBiotechnology TypePrivately Held, VC-backed Founded2024 Employees51-200 Specialties gene therapyrare diseasequality assurancegxp operationsregulatory affairsclinical developmentdiscovery researchtranslational researchvector researchbiomedical researchorphan diseasegenetic diseasegenetic medicineaav vectorsbioinformaticscapsid engineeringand genome editing About the Role The Company is seeking an Executive Director of Clinical Development to provide clinical and medical oversight across all phases of drug development. The role includes shaping clinical development strategy, designing and executing trials, reviewing study protocols and related documents, and interpreting results for regulatory submissions and publications. The successful candidate will oversee medical monitoring, safety review, pharmacovigilance coordination, and clinical data analysis, while partnering with research teams and external stakeholders. They may also represent the organization in discussions with investigators, experts, regulators, and other partners. Candidates should have an MD, preferred, and 5–7 years of clinical drug development experience in a pharmaceutical, biotechnology, or related setting. Experience in pediatric neurology or neuromuscular neurology is required, while relevant board certification and experience across Latin America, Europe, and the Middle East and North Africa are preferred. Applicants should demonstrate expertise in Phase 1–4 trial design, execution, medical oversight, safety monitoring, and data interpretation, particularly for rare diseases and gene therapy programs. Hands-on experience with regulatory submissions and health authority interactions, including investigational applications, clinical trial applications, and marketing authorization submissions, is also required. Hiring Manager TitleChief Medical Officer Functions Medical Care/Hospital Administration