Senior Clinical Scientist, Late Clinical/Global Drug Development

Location
Princeton, NJ, United States
Posted
Sep 19, 2020
Ref
R1527891
Required Education
Doctorate/PHD/MD
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

SUMMARY: Responsible for implementation, planning, and execution of assigned clinical trial activities; Serves as a Clinical Trial Lead for one or more trials

JOB DESCRIPTION
  • Successfully lead, plan, and execute trial level activities for multiple trials with minimal to moderate level of supervision
  • Provide scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership)
  • Co-Lead study team meetings in partnership with GDO protocol manager; and collaborate with cross functional study team members
  • May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning)
  • Responsibilities include, but are not limited to:
  • Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
  • Plan and lead the implementation all study startup/conduct/close-out activities as applicable
  • Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
  • Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
  • Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
  • Develop clinical narrative plan; review clinical narratives
  • Clinical data trend identification; provide trends and escalate questions to Medical Monitor
  • Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
  • Site-facing activities such as training and serving as primary contact for clinical questions
  • Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)
  • Evaluation of innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)
  • Collaborate and serve as primary liaison between external partners for scientific advice


JOB REQUIREMENTS
  • Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
  • 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 team activities
  • Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
  • 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)
  • Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
  • 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; 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
  • Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred); 5+ years of experience in clinical science, clinical research, or equivalent


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.