Medical Director/Sr. Medical Director, Clinical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the physician lead for CAR T-cell therapy clinical trials focusing on autoimmune disease indications, collaborating with both internal and external cross-functional teams.

• Supervise the medical monitoring of clinical trials, including interactions with site investigators and external medical monitors.

• Collaborate with clinical operations, biometrics, regulatory, and commercial teams to ensure strategic alignment and effective execution.

• Direct the design, execution, and analysis of clinical trials within the assigned program.

• Offer medical and scientific insights for clinical development plans, study protocols, investigator brochures, and regulatory submissions.

• Conduct medical reviews, analyses, and interpretations of safety, efficacy, pharmacokinetics, and biomarker data.

• Create clinical trial documents such as protocols, informed consent forms (ICFs), clinical development plans, and publications.

• Lead the preparation of clinical sections in regulatory documents, including investigator brochures, safety updates, clinical study reports, and responses to health authorities.

• Actively engage with external investigators and researchers to identify, assess, and support investigator-sponsored studies and foster research collaborations.

⛳️ Requirements

• MD, DO, (or equivalent international degree) or MD-PhD degree is mandatory.

• Minimum of 5 years of clinical research experience, with at least 3 years in the industry focused on late-phase clinical development and the design and execution of clinical trials. Experience in late-stage clinical development is preferred.

• Specialized training in neurology, rheumatology, nephrology, and/or industry experience in the clinical development of cell therapies and/or treatments for autoimmune diseases is highly desirable.

• Demonstrated ability to interpret, discuss, and present efficacy and safety data.

• In-depth knowledge of GCP/ICH guidelines, clinical trial design, clinical development processes, and regulatory requirements.

• Exceptional communication skills and the ability to build effective working relationships with investigators, collaborators, scientific advisors, CROs, and corporate partners.

🏝️ Benefits

• Annual salary ranging from $330,000 to $370,000

• Eligibility for bonuses

• Participation in the Company’s stock plan