Senior Medical Director
Senior Medical Director
Senior Medical Director
Umoja Biopharma
Umoja Biopharma is an innovative biotech start-up focused on transforming cancer treatment through a novel immunotherapy platform. They are seeking a Medical Director to provide clinical leadership for their in vivo CAR-T therapy programs, contributing to clinical strategy and regulatory interactions. The role emphasizes collaboration across various teams and requires expertise in cell and gene therapy, particularly in oncology or rheumatology.
Qualification
- Deep experience in cell and gene therapy.
- Strong track record in oncology or rheumatology clinical development.
- Experience in clinical strategy and study design.
- Knowledge of regulatory interactions and compliance.
- Ability to work cross-functionally with R&D, Clinical Operations, and Program Leadership teams.
Responsibility
- Provide medical leadership and clinical oversight for ongoing and planned in vivo CAR-T therapy programs.
- Contribute to the clinical development strategy, including indication selection, trial design, and endpoints.
- Serve as medical monitor for clinical studies, ensuring patient safety, data integrity, and compliance with GCP and regulatory requirements.
- Lead preparation of clinical protocols, investigator brochures, clinical sections of regulatory filings (IND, CTA, BLA), and other medical documents.
- Partner with Clinical Operations on trial execution.
