Executive Director, Clinical Development
Confidential
Executive Director, Clinical Development
About the Company
Innovative biotechnology (BioTech) company specializing in gene therapy for rare diseases
Industry
Biotechnology
Type
Privately Held, VC-backed
Founded
2024
Employees
51-200
Specialties
- gene therapy
- rare disease
- quality assurance
- gxp operations
- regulatory affairs
- clinical development
- discovery research
- translational research
- vector research
- biomedical research
- orphan disease
- genetic disease
- genetic medicine
- aav vectors
- bioinformatics
- capsid engineering
- and 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 Title
Chief Medical Officer
Functions
- Medical Care/Hospital Administration
Vacancy posted 2 days ago
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