Job Title: Global Clinical Development Strategy Expert
Location: Tokyo, Japan
Job Summary:
Sanofi is seeking a Global Clinical Development Strategy Expert (GCDSE) to lead the design and development of clinical studies for vaccine programs. The GCDSE will be responsible for global ownership of the Clinical Strategy and Clinical Development Plans (CDP), ensuring alignment with regulatory standards, ethical requirements, and the Target Product Profile. This role will also oversee the clinical representation in global project teams and interactions with regulatory and public health agencies.
Key Responsibilities:
CDP Implementation & Clinical Strategy:
Lead the clinical study team and implement clinical activities in vaccine development, registration, and commercialization.
Ensure studies are compliant with ICH-GCP and regulatory standards.
Oversee global consistency in study protocols and safety data quality.
Collaborate with stakeholders across medical affairs, clinical study management, and regulatory affairs.
Regulatory & Scientific Input:
Provide clinical content for regulatory submissions and study documents.
Lead responses to clinical questions from regulatory authorities, including PMDA and NDA.
Support epidemiology studies and provide medical guidance related to safety.
Medical Monitoring & Safety:
Ensure the safety of study subjects, providing medical guidance and overseeing clinical monitoring.
Address potential issues promptly, coordinating with global/regional teams.
Data Interpretation & Publications:
Interpret study results and communicate findings to internal and external stakeholders.
Contribute to scientific publications and present study outcomes at scientific meetings and congresses.
Stakeholder Engagement & Communication:
Build relationships with key stakeholders, including public health agencies and investigators.
Lead communication efforts with global health authorities and scientific communities.
Team Leadership & Mentorship:
Lead and mentor multidisciplinary teams, fostering collaboration and innovation.
Ensure timely and effective reporting of clinical progress to senior management.
Qualifications:
Education: MD, PhD, or PharmD, preferably with a background in Pediatrics, Internal Medicine, Immunology, or Infectious Diseases.
Experience:
3-5 years of pharmaceutical industry experience or 5+ years in clinical trials in an academic environment.
Demonstrated scientific productivity, including publications and research reports.
Expertise in clinical operations, regulatory interactions, and data analysis.
Skills:
Strong leadership, organizational, and communication skills.
Ability to work in a matrixed, cross-cultural environment.
Fluent in English and local language.
Selling Points:
Global Leadership: Lead the clinical strategy and protocol development for vaccine programs worldwide.
Cross-Functional Expertise: Act as the clinical voice in global project teams and regulatory discussions.
Ethics & Innovation: Drive high-standard clinical trials and contribute to global vaccine advancement.
Gujarat :
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