Global Clinical Development Strategy Expert - Vaccine

Location: Waltham, MA

Work model: Hybrid

About the Job

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

The Director Clinical Development is the clinical/medical/scientific expert who supports the translation of a target product profile into a feasible Clinical Development Plan (CDP), taking into account scientific environment, resource possibilities, clinical feasibility and timely execution. This requires a good understanding of the possibilities and limitations of the operational environment, team leadership skills, communication skills, knowledge of the therapeutic area, ability to understand business needs and how to translate them into feasible operational plans.

• Provide scientific and clinical leadership in the design and development of clinical studies and programs for Sanofi Vaccines R&D.
  
• Have global responsibility and ownership for the Clinical Strategy, the respective Clinical Development Plans (CDP) and study protocols for projects/programs.
  
• Ensure that CDPs are written in accordance with the Target Product Profile (TPP), Integrated Evidence Generation Plan (IEGP) and according to Franchise and Global Project Team strategy and assures global consistency across regions.
  
• Provide clinical and R&D expertise, guidance and direction in the context of the region/country, in which they operate.
  
• Establishes the conditions essential for determining the safety of all subjects involved in Clinical trials for the vaccine development candidates they oversee.
  
• Provide clinical expertise and support to regulatory activities (Health Authority meetings, communications, CTD submissions)
  

• You will lead the clinical study team and as such require leadership skills, communications skills, ability to operate in multidisciplinary and multi-cultural teams, ability to inspire teams.
  
• MD is a minimum scientific qualification with 5-10 years pharmaceutical industry experience preferred, with exposure to diverse array of programs in early and late-stage development or5-10 years or more experience conducting early and late-stage clinical trials in an academic environment
  
• M.D. with completion of an approved residency training program in a related field or equivalent is preferred.
  
• Physician, with training in Infectious Diseases, Geriatrics, Pediatrics, or Internal Medicine in addition to training or experience in immunology, preferred.
  
• Demonstrated scientific productivity (publications, research reports, etc.) and ability to critically review/interpret research data, preferred.
  
• Demonstrated planning, organizational skills, interpersonal, problem solving and excellent written and verbal communication skills.
  
• Written and oral fluency in English required.
  

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.