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Scientific Project Lead

7 days ago

Summit, New Jersey, United States Bristol-Myers Squibb Full time
Pioneering New Treatments in Early Clinical Development

Bristol Myers Squibb is a pioneering pharmaceutical company dedicated to bringing new treatments to patients with serious diseases. We are seeking a highly skilled Early Development Specialist to join our team in Early Clinical Development.

About the Role:

  • We are responsible for designing and delivering clinical studies and programs that bring new treatments to patients with serious diseases.
  • This role supports the Immunology, Cardiovascular, Fibrosis, and Neuroscience teams in implementing all facets of early clinical studies.
  • The ideal candidate will have excellent verbal and written communication skills, be able to effectively collaborate across functions and job levels, and possess a strong sense of teamwork and leadership.

Key Responsibilities:

  1. Maintain a thorough understanding of assigned protocols and protocol requirements.
  2. Plan and lead the implementation of clinical study startup/conduct/close-out activities.
  3. Evaluate innovative trial designs in collaboration with the study physician.
  4. Manage protocol and ICF development process (e.g., documents and amendments).
  5. Serve as primary contact for site-facing activities such as training and support for clinical questions.
  6. Conduct and oversee activities related to data generation and validation.
  7. Develop clinical narrative plan and review clinical narratives.
  8. Provide information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
  9. Review/develop site and CRA training materials and presentation at SIV and Investigator meetings.
  10. Author/review clinical study reports (CSRs) and clinical portions of Regulatory Documents.
  11. Collaborate and serve as primary liaison between external partners for scientific advice.
  12. Author/review abstracts, presentations, and manuscripts for external publications.

Requirements:

  • Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).
  • 1+ years experience in clinical science and clinical research.
  • Proficient hands-on knowledge and experience in clinical development process.
  • Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.