AI-Powered Clinical Research Director

BioSpace; Cambridge (MA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Health benefits

Parental leave (14+ weeks)

Competitive compensation

Job summary

Sanofi is seeking a Clinical Research Director in Cambridge, MA to lead late-stage oncology development and oversee regulatory strategy. You will drive study design, execution, and collaboration with investigators and cross-functional teams to advance programs.

Ideal candidates hold an MD with Hematology/Oncology fellowship and 4+ years in Oncology development, with demonstrated leadership and experience contributing to regulatory filings.

Qualifications

• MD degree or equivalent required.
• Hematology/Oncology fellowship required.
• Minimum 4 years of oncology development experience.
• Experience in late-stage clinical development preferred.
• Proven ability to interact with external investigators and multidisciplinary teams.
• Solid understanding of regulatory, quality and compliance standards.

Responsibilities

• Establishes or adapts clinical development plan for programs and coordinates with investigators and regulatory authorities.
• Leads execution of clinical development activities and studies, including protocol reviews and amendments.
• Reviews informed consent forms and trial documents; chairs study-specific committees with operational support.
• Interprets study results, contributes to clinical study reports and summaries; supports regulatory submissions.
• Provides clinical guidance to Clinical Operations, Biostatistics, Translational Medicine, and other functions.

Skills

Oncology development

Clinical study oversight

Regulatory strategy

External investigator collaboration

Leadership

Education

MD degree or equivalent

Hematology/Oncology fellowship

Job description

Sanofi is seeking a Clinical Research Director in Cambridge, MA to lead late-stage oncology development and oversee regulatory strategy. You will drive study design, execution, and collaboration with investigators and cross-functional teams to advance programs.

Ideal candidates hold an MD with Hematology/Oncology fellowship and 4+ years in Oncology development, with demonstrated leadership and experience contributing to regulatory filings.