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Confidential

Vice President of Clinical Development

Confidential, Boston, Massachusetts, us, 02298

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Vice President of Clinical Development About the Company Innovative provider of gene therapies to people with rare diseases Industry Biotechnology Type Subsidiary of a Public Company Founded 2015 Employees 51-200 Categories Biotechnology Ex-vivo Gene Therapy Rare Diseases Stem Cell Research Health Diagnostics Health Care Genetics

Specialties stem cell technology gene therapy orphan diseases paediatric diseases rare diseases and genetic diseases

Business Classifications B2B

About the Role The Company is seeking a VP of Clinical Development to lead the Clinical Science organization in driving the strategy for clinical development, managing clinical studies, and overseeing regulatory documentation and interactions. The successful candidate will be responsible for ensuring that clinical development plans and protocols align with the strategic, scientific, and regulatory objectives of the company's clinical assets. This role requires a leader who can cultivate a high-performing, collaborative culture, and who has a proven track record in designing, leading, and executing clinical trials, particularly in the areas of ultra-rare diseases, gene therapy, pediatrics, neurometabolic disease, and IBD. The VP will also be accountable for departmental adherence to GxP, and GCP, and for effective cross-functional collaboration with various teams supporting clinical development.

Candidates for the VP of Clinical Development position at the company should have at least 10 years' of experience in clinical development, with a strong preference for those with a background in gene therapy, immunology, and/or hematology/oncology. The role demands a strategic thinker with exceptional organizational, presentation, and communication skills, who is adept at managing multiple priorities and projects. The ideal candidate will have a medical degree (MD/MBBS), experience in leading a matrix team, and a deep understanding of the regulatory environment, including experience with regulatory agencies. A proven ability to develop and execute clinical development strategies that align with corporate goals, as well as experience in pharmacovigilance and US regulatory affairs, is highly desirable. The VP should be a mature professional with a strong record of building and mentoring high-performing clinical teams, and who thrives in a dynamic, biotech environment. Hiring Manager Title Chief Medical Officer Travel Percent 20% Functions Medical Care/Hospital Administration