Medical Director/Sr. Medical Director, Clinical Development

Team: Clinical

Location: Remote

Commitment: Full Time

Workplace Type: remote

Responsibilities

Serve as the physician lead for CAR T-cell therapy clinical trials in autoimmune disease indications, in partnership with internal and external cross-functional teams.
Oversee medical monitoring of clinical trials, including engagement with site investigators and external medical monitors.
Partner with clinical operations, biometrics, regulatory, and commercial teams to ensure alignment on strategy and execution.
Lead design, execution, and interpretation of clinical trials across assigned program
Provide medical and scientific input into clinical development plans, study protocols, investigator brochures, and regulatory submissions.
Medical review, analysis, and interpretation of safety, efficacy, and PK and biomarker data.
Development of clinical trial documents including protocols, ICFs, clinical development plans, and publications.
Lead 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.

Qualifications 

MD, DO, (or ex-US equivalent) or MD-PhD degree required.
5+ years of clinical research experience with 3+ years of industry experience in late phase clinical development involved in the design and execution of clinical trials. Experience in late-stage clinical development preferred.
Specialty training in neurology, rheumatology, nephrology and/or industry experience in clinical development of cell therapies and/or therapies for autoimmune diseases is highly preferred.
Proven ability to interpret, discuss and present efficacy and safety data.
Strong knowledge of GCP/ICH, clinical trial design, clinical development processes, and regulatory requirements.
Strong ability to communicate and establish effective working relationship with investigators, collaborators, scientific advisors, CROs, and corporate partners.