Clinical Research Director, I&I (IBD)
Location: Cambridge, MA
Employment: Permanent
Salary Range: USD 201,000 - 290,333
Posted on: Apr. 02, 2025
Closing on: Apr. 28, 2025
Company: Sanofi
Job Summary:
The Clinical Research Director (CRD) for Immunology & Inflammation (I&I), specializing in Inflammatory Bowel Disease (IBD), will be responsible for creating the clinical development plan for assets in this therapeutic area. The CRD will collaborate with various teams to design and execute clinical trials, advancing scientific knowledge in immunology, and ensuring regulatory compliance and study progression.
Main Responsibilities:
Clinical Development Strategy:
Develop and document the clinical development plan (CDP) for IBD assets, collaborating with global project teams and internal stakeholders (clinical operations, translational medicine, regulatory affairs, etc.).
Lead a clinical subteam to design clinical studies and develop protocols.
Study Execution and Compliance:
Oversee clinical study execution in compliance with SOPs, GCP, ICH guidelines, and relevant regulations.
Review documents supporting clinical development, including Investigator’s brochures, regulatory documents, and clinical development plans.
Regulatory Support:
Support drug registration processes, contributing to submission dossiers and preparing for advisory committees.
Represent Clinical Development in meetings with Health Authorities, incorporating feedback into strategy.
Data Review and Interpretation:
Contribute to data analysis, interpretation, and publication of clinical study results.
External Scientific Collaboration:
Engage with external scientific and clinical communities to incorporate feedback into internal programs.
Align clinical strategy with partners in alliance projects and evaluate business development opportunities.
Leadership and Ethical Standards:
Lead with integrity and uphold high ethical standards in clinical research.
Provide scientific leadership in immune-driven diseases and clinical immunology.
Scientific and Technical Expertise:
Requirements:
Medical Doctor, board-certified or equivalent in internal medicine or clinical immunology. Gastroenterology is a plus.
More than 5 years of relevant experience in immune-driven diseases (Gastroenterology is a plus).
Strong scientific background in clinical research, pharmaceutical experience, or experimental medicine within internal medicine and clinical immunology.
Knowledge of drug development and regulatory processes.
Familiarity with biomarker and precision medicine approaches, novel clinical trial designs, and statistical methods.
About You:
Qualifications:
MD, board-certified or equivalent in internal medicine or clinical immunology. Gastroenterology is a plus.
More than 5 years of relevant clinical, scientific, or industry experience in immune-driven diseases.
Strong academic background with expertise in clinical research and drug development.
Exceptional interpersonal, communication, and leadership skills.
Fluent in English (verbal and written communication).
Why Choose Us?
Growth Opportunities:
A supportive team offering numerous opportunities for career advancement, both locally and internationally.
Rewards and Benefits:
A comprehensive rewards package including high-quality healthcare, wellness programs, and at least 14 weeks’ gender-neutral parental leave.
Commitment to Diversity:
Sanofi is committed to fostering a diverse and inclusive workforce, offering equal opportunities to all applicants.
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