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Medical Director
1 month ago
Cartesian Therapeutics is a pioneering company in the field of mRNA cell therapies for the treatment of autoimmune diseases. We are seeking a highly motivated Associate Medical Director with extensive experience in Phase 1-2 clinical programs to contribute to our innovative initiatives.
Key Responsibilities:
- Collaborate with cross-functional teams to serve as the medical monitor for assigned Phase 1-2 mRNA CAR T-cell therapy clinical trials in multiple autoimmune disease indications.
- Develop and implement pharmacovigilance processes and procedures to ensure compliance with regulatory requirements, company objectives, and quality standards.
- Conduct medical review, analysis, and interpretation of safety, efficacy, and PK and biomarker data.
- Assist in the development of clinical trial documents, including protocols, ICFs, clinical development plans, and publications.
- Support the development of clinical sections of regulatory documents, including the IB, safety updates, clinical study reports, and responses to Health Authorities.
- Engage with external investigators and researchers to identify, evaluate, and support investigator-sponsored studies and drive research collaborations.
Requirements and Desired Experience:
- MD (or equivalent) or MD-PhD degree required. Advanced degree or research experience in immunology preferred.
- 5+ years of clinical research experience with 2+ years of industry experience in clinical development involved in the design and execution of clinical trials. Experience in early clinical development and translational medicine preferred.
- Specialty training in rheumatology and/or industry experience in clinical development of therapeutics in autoimmune diseases.
- Proven ability to interpret, discuss, and present efficacy and safety data.
- Working knowledge of GCP/ICH, clinical trial design, clinical development processes, and regulatory requirements.
- Strong ability to communicate and establish effective working relationships with investigators, collaborators, scientific advisors, CROs, and corporate partners.
Cartesian Therapeutics is an Equal Opportunity Employer committed to fostering an inclusive environment where all employees are treated fairly without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, ancestry, disability, marital status, genetic information, military status, or any other characteristic protected under applicable law.