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Senior Clinical Scientist

5+ 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

Senior Clinical Scientist - Lunsekimig Project Team
Location: Cambridge, MA

About the Job
Are you ready to help shape the future of medicine? At Sanofi, we are accelerating drug discovery and development to improve the lives of patients and their families. Your expertise could play a pivotal role in driving this progress.

Our Team
The Lunsekimig project team is part of the Early Development group within the Inflammation & Immunology Therapeutic Area at Sanofi. We are developing a novel pentavalent, bispecific Nanobody aimed at treating asthma and other “Type 2” inflammatory diseases. As we expand into multiple high-impact diseases with several clinical trials scheduled in the next year, we are growing our team to support this exciting growth, including the initiation of phase 3 clinical trials in the respiratory space.

Main Responsibilities
The Lunsekimig team is seeking a highly skilled Senior Clinical Scientist to assist and support the Clinical Research Director (CRD) in contributing to the medical and scientific aspects of clinical studies. This role encompasses operational responsibilities from clinical trial setup to clinical study report creation, in compliance with regulatory and quality processes.

Strategic Clinical Development Plans:

  • Contribute to the preparation and review of study documents requiring scientific input (e.g., protocols, amended protocols, patient information, study reports, and communications to internal/external stakeholders).
  • Support the CRD in providing medical responses to inquiries from Health Authorities, IRBs, investigators, and experts.
  • Contribute to the identification and monitoring of risks, quality tolerance limits, and deviations, supporting the development of the study risk management plan.
  • Assist in preparing presentations for governance committees to endorse clinical strategic plans.
  • Help design and execute clinical studies outlined in the development plan.
  • Support the preparation of key clinical documents such as protocols, informed consent, and benefit-risk assessments.

Team Development:

  • Assist in the onboarding and training of new Clinical Scientists and other team members.
  • Support cross-program strategies and activities in collaboration with the CRD, Clinical Lead, and Global Project Head.
  • Maintain deep scientific and technical expertise in immunology, dermatology, pulmonology, or other disease areas within Immunology and Inflammation.

Skills & Experience (mandatory):

  • Advanced degree preferred (PharmD, PhD, or Biomedical Science Master's is a plus).
  • 5+ years of industry experience, including both research and clinical development.
  • At least 1 year of experience as a Clinical Scientist.
  • Proficiency in interpreting clinical literature and clinical study results.
  • Experience supporting clinical trial preparation and execution.
  • Collaborative and transparent working style, with strong leadership, interpersonal, communication, and presentation skills.

Why Choose Us?

  • 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 promotion or lateral moves, at home or internationally.
  • Enjoy a well-crafted rewards package that recognizes your contributions and amplifies your impact.
  • Take care of yourself and your family with comprehensive health and wellness benefits, including high-quality healthcare, prevention 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 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, affectional or sexual orientation, disability, veteran status, or any other characteristic protected by law.