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Global Clinical Development Strategy Expert - Vaccine

5-10 years
Not Disclosed
10 Dec. 10, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Global Clinical Development Strategy Expert - Vaccine
Location: Waltham, MA
Work Model: Hybrid

About the Job
At Sanofi, we are on a mission to stay ahead of infectious diseases, delivering over 500 million vaccine doses every year. Our global teams are advancing new technologies to protect people and foster healthy communities. We are constantly chasing the miracles of science, with a single purpose: to improve lives through progress and innovation.

The Global Clinical Development Strategy Expert (Director Clinical Development) will serve as the clinical/medical/scientific expert in the development of clinical strategies and plans for vaccine programs. This role involves translating target product profiles into feasible Clinical Development Plans (CDP), considering scientific, operational, and resource constraints, while ensuring timely execution. You will lead and manage the global clinical development strategy, offering scientific and clinical leadership for vaccine programs and overseeing their execution in line with regulatory and business needs.

Main Responsibilities

  • Provide scientific and clinical leadership in designing and developing clinical studies and programs for Sanofi Vaccines R&D.
  • Assume global responsibility for the Clinical Strategy and the development and execution of the Clinical Development Plans (CDP) and study protocols.
  • Ensure CDPs align with the Target Product Profile (TPP), Integrated Evidence Generation Plan (IEGP), and global project team strategies, ensuring consistency across regions.
  • Provide expert guidance in clinical and R&D activities, while considering regional and country-specific contexts.
  • Oversee clinical trial safety, ensuring all necessary conditions are met for the safety of participants in vaccine clinical trials.
  • Support regulatory activities including Health Authority meetings, submissions, and CTD (Common Technical Document) submissions.

About You

  • Experience:
    • 5-10 years of pharmaceutical industry experience, particularly in early and late-stage vaccine development, or 5-10 years of experience in conducting early/late-stage clinical trials in an academic environment.
    • Experience in leading clinical trials and programs with a focus on vaccines and infectious diseases.
  • Education:
    • M.D. or equivalent, with completed residency training in a relevant field.
    • Additional training in Infectious Diseases, Geriatrics, Pediatrics, or Internal Medicine, along with expertise in immunology, is preferred.
  • Skills:
    • Strong leadership, communication, and organizational skills.
    • Ability to lead and inspire multidisciplinary and multicultural teams.
    • Proven ability to review and interpret research data critically, with scientific productivity (publications, research reports).
    • Proficiency in written and spoken English.

Why Choose Us?

  • Career Growth: Join a supportive, future-focused team with opportunities to grow and advance your career globally.
  • Comprehensive Rewards: We offer a competitive package that recognizes your contributions and enhances your impact.
  • Health & Wellbeing: Enjoy a range of health benefits, including high-quality healthcare, wellness programs, and 14 weeks of gender-neutral parental leave.

Sanofi is an Equal Opportunity and Affirmative Action employer. We are committed to diversity and inclusion and encourage applicants from all backgrounds to apply.