Senior Clinical Scientist, Late Clinical/Global Drug Development

Location
Princeton, NJ, United States
Posted
Sep 21, 2020
Ref
R1527889
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

Evaluation of innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)

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)

Site-facing activities such as training and serving as primary contact for clinical questions

Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team

Clinical data trend identification; provide trends and escalate questions to Medical Monitor

Develop clinical narrative plan; review clinical narratives

Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.

Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities

Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)

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.