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Clinical Scientist/Senior Clinical Scientist
Immunology
Posted on 9/1/2022
INACTIVE
Locations
Summit, NJ, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Google Cloud Platform
Leadership
Management
Research
Writing
PowerPoint/Keynote/Slides
Word/Pages/Docs
Requirements
  • Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred)
  • For Clinical Scientist minimum 2 years of experience in clinical science, clinical research, or equivalent
  • For Senior Clinical Scientist minimum 5+ years of experience in clinical science, clinical research, or equivalent
  • Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
  • Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
  • Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
  • Excellent verbal, written, communication and interpersonal skills
  • Must be able to effectively communicate and collaborate across functions and job levels
  • Ability to assimilate technical information quickly
  • Routinely takes initiative
  • Detail-oriented
  • Strong sense of teamwork; ability to lead matrix team activities
  • Proficient in Medical Terminology and medical writing skills
  • Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
  • Proficient critical thinking, problem solving, decision making skills
  • Understanding of functional and cross-functional relationships
  • Commitment to Quality
  • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism
  • Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)
  • Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools
Responsibilities
  • Responsible for implementation, planning, and execution of assigned clinical trial activities
  • Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision
  • Provides scientific and clinical leadership to clinical scientists on study team (matrix leadership)
  • May support clinical development planning in collaboration with Early Clinical Development physician(s)
  • Maintain a thorough understanding of assigned protocols and protocol requirements and educate team members
  • Plan and lead the implementation of clinical study startup/conduct/close-out activities as applicable
  • Evaluate innovative trial designs in collaboration with the study physician
  • Manage protocol and ICF development process (e.g., documents and amendments) with minimal guidance; includes writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality in collaboration with Medical Writing. Present to governance committee and early clinical development team meetings as required
  • Serve as primary contact for site-facing activities such as training and support for clinical questions
  • Conduct and oversee activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review
  • Identify clinical data trends; provide trends and escalate questions to study physician
  • Develop clinical narrative plan and review clinical narratives
  • Provide information required by Protocol Manager for development of trial budget, CRO scope of work, etc
  • Review/develop site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., safety review) activities
  • Author/review clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR, regulatory responses)
  • Collaborate and serve as primary liaison between external partners for scientific advice
  • Author/review abstracts, presentations, and manuscripts for external publications
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company Overview
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.