[reputed company Director/Sr. Medical Director, Clinical Development

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are seeking a Medical Director/Sr. Medical Director for Clinical Development to reputed company CAR T-cell therapy reputed company and reputed company medical monitoring, ensuring alignment with cross-functional teams and providing medical input into clinical development plans.

Responsibilities

• Serve as the physician reputed company for CAR T-cell therapy reputed company in autoimmune disease indications, in partnership with reputed company cross-functional teams
• reputed company medical monitoring of reputed company, including engagement with site investigators and external medical monitors
• Partner with clinical operations, biometrics, regulatory, and reputed company teams to ensure alignment on reputed company and execution
• reputed company design, execution, and interpretation of reputed company across assigned program
• reputed company 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
• reputed company the development of clinical sections of regulatory documents including the IB, safety updates, clinical study reports, and responses to Health Authorities
• reputed company engage with external investigators and researchers to identify, evaluate, and support investigator sponsored studies and drive research collaborations

Skills

• 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 reputed company
• 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
• 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

Benefits

• This position is also eligible for bonus, benefits, and participation in Company’s stock plan.

reputed company

Company H1B Sponsorship