Cartesian Therapeutics is a clinical-stage company pioneering mRNA cell therapies for the treatment of autoimmune diseases.
We are actively seeking a highly motivated Associate Medical Director with robust experience in Phase 1-2 clinical programs to join our dynamic team.
This individual will play a role as a Medical Monitor and Pharmacovigilance specialist, contributing directly to our cutting-edge initiatives.
Reporting directly to the Chief Medical Officer, this position offers an exciting opportunity to make a significant impact in the field of medical research and therapeutic development.
Key Responsibilities :
- Serve as the medical monitor for assigned Phase 1-2 mRNA CAR T-cell therapy clinical trials in multiple autoimmune disease indications, in partnership with internal and external cross-functional teams.
- Develop and design pharmacovigilance processes and procedures to ensure compliance with regulatory requirements, company objectives, and quality standards.
- Medical review, analysis, and interpretation of safety, efficacy, and PK and biomarker data.
- Assist with development of clinical trial documents including protocols, ICFs, clinical development plans, and publications.
- Assist with the development of clinical sections of regulatory documents including the IB, safety updates, clinical study reports, and responses to Health Authorities.
- Actively engage with external investigators and researchers to identify, evaluate, and support investigator-sponsored studies and drive research collaborations.
Requirements and Desired Experience :
- MD (or ex-US 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 is an Equal Opportunity Employer and is committed to fostering an environment in which 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.
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