Senior Clinical Scientist
Bristol Myers Squibb
full-time
Posted on:
Location Type: Office
Location: Princeton • New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $224,610 - $272,178 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Serve as a subject matter expert for the development, conduct and regulatory submission of clinical studies including but not limited to Protocol development
- Clinical data review
- Data interpretation; review and validation of CSRs
- Regulatory requirements and documents (e.g., IB, submissions, etc)
- Site/KOL engagement strategies and implementation
- Harmonization of standards across programs and/or indications (e.g. data standards, programming specifications, statistical analysis plans)
- Ensure lessons learned are communicated across teams and ensure alignment so that unnecessary amendments are avoided and to align with asset/TA-level protocol elements
- May serve as Trial Lead for complex clinical studies
- May present data/information to internal and external stakeholders including investigators and study staff
- Independently, proactively, and consistently develop, enact, and share best practices
- Clinical oversight of study data, specifically, leverages best practices to guide the CS team(s) in: understanding interdependencies of CRFs data conventions/ rules data review tools and visualizations; collaboration with DM and Programming
- Serve as peer coach or mentor
- Actively participate and demonstrate clinical leadership in study team meetings and other cross-functional meetings as warranted
- Plan execution of deliverables and anticipate future work/identification of issues, and remediation activities
- Partner with CCOE Clinical Capabilities Team to represent CS function in cross functional activities, support or lead process improvement and departmental training activities
Requirements
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)
- 10+ years of experience in Clinical R&D roles/responsibilities, including functioning in a matrix environment
- Recognized as a Therapeutic Area and/or Functional expert
- Advanced knowledge of GCP/ICH, overall drug development process from discovery to registration, study design, statistics, clinical operations, regulatory environment
- Advanced verbal, written, communication and interpersonal skills. Must be able to effectively collaborate across all functions and all job levels
- Ability to assimilate technical information quickly
- Demonstrated ability to influence within study team, TA, department, functions
- Leadership presence and strong presentations skills
- Proactive / Drive for results
- Proficiency in leading teams and activities
- Advanced knowledge and skills to support scientific data review, trend identification, data interpretation, and reporting
- Advanced knowledge of the therapeutic area
- Advanced critical thinking, problem solving, decision making skills
- 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)
- Advanced planning/project management skills (ability to develop short to long-range plans that are realistic and effective in meeting goals)
Benefits
- Medical, pharmacy, dental and vision care.
- Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
- Financial well-being resources and a 401(K).
- Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
- Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
- Parental, caregiver, bereavement, and military leave.
- Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
- Other perks like tuition reimbursement and a recognition program.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical study developmentclinical data reviewdata interpretationregulatory submissionsprotocol developmentstatistical analysis plansGCPICHdrug development processscientific data review
Soft skills
communication skillsinterpersonal skillsleadership presenceproblem solvingcritical thinkinginfluencecollaborationproactiveadaptabilityplanning
Certifications
MDPhDPharm DMSRN