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Global Clinical Development Strategy Expert

2+ 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

Director, Global Clinical Development Strategy Expert
Location: Swiftwater, PA | Cambridge, MA | Orlando, FL | Morristown, NJ (Flexible US Site)

About the Job
Join a global healthcare leader that is at the forefront of delivering life-saving vaccines. We provide over 500 million vaccine doses annually and are constantly exploring innovative technologies to protect people and foster healthy communities. Our teams are driven by the pursuit of scientific breakthroughs, making a meaningful impact on patients worldwide.

As a Director, Global Clinical Development Strategy Expert, you will lead the design and execution of clinical development plans (CDPs) in alignment with Sanofi Vaccines R&D goals. You will ensure the successful translation of a target product profile into feasible clinical plans, integrating scientific, operational, and business requirements for the development of vaccine candidates.

Main Responsibilities

  • Lead the clinical strategy and development of clinical studies and programs for Sanofi Vaccines R&D.
  • Hold global responsibility for the Clinical Development Plan (CDP), study protocols, and alignment with the Target Product Profile (TPP) and Integrated Evidence Generation Plan (IEGP).
  • Ensure consistency of CDPs across regions while tailoring them to regional or country-specific requirements.
  • Provide clinical expertise and leadership in vaccine safety, ensuring the safety of all trial participants.
  • Collaborate with regulatory teams to provide clinical support for Health Authority meetings, submissions, and communications.
  • Lead cross-functional teams and work with multi-disciplinary and multi-cultural stakeholders to deliver clinical trial objectives.

About You

  • Education: MD with training in Infectious Diseases, Geriatrics, Pediatrics, Internal Medicine, or immunology, with clinical or academic experience in vaccine development.
  • Experience: 5-10 years of pharmaceutical industry experience, ideally with experience in both early- and late-stage clinical trials or significant academic research.
  • Proven scientific productivity and ability to critically interpret research data.
  • Strong leadership, organizational, communication, and interpersonal skills to lead diverse, global teams.
  • Ability to work independently and manage complex projects across cross-cultural teams.

Why Choose Us?

  • Be part of a team bringing life-changing scientific advancements to the world.
  • Unlock opportunities for career growth with flexible paths for promotion and lateral moves, both in the US and internationally.
  • Enjoy a comprehensive rewards package that recognizes your impact, including competitive healthcare, wellness programs, and at least 14 weeks of gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to fostering a diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender identity, sexual orientation, disability, veteran status, or any other characteristic protected by law.