Senior Principal Scientist, Clinical Research, Immunology
MSD
Clinical Scientist, Cell Therapy
Bristol Myers Squibb
full-time
Posted on:
Location Type: Hybrid
Location: Madison • New Jersey, Washington • 🇺🇸 United States
Visit company websiteSalary
💰 $150,770 - $200,974 per year
Job Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct.
- May serve as Clinical Trial Lead for one or more trials.
- May lead or support trial level activities for one or more trials with the necessary supervision.
- May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members.
- Collaborate and liaise with external partners (e.g., KOLs).
- Seek out and enact best practices with instruction.
- Provide regular and timely updates to manager/management as requested.
- Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required.
- Conduct literature review.
- Submit clinical documents to TMF.
- Develop site and CRA training materials and present these at SIVs and Investigator meetings.
- Review clinical narratives.
- Monitor clinical data for specific trends.
- Develop Data Review Plan in collaboration with Data Management.
- Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
- Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission).
Requirements
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred).
- Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
- Ability to understand assigned protocol(s) and their requirements.
- Basic knowledge skills to support program-specific data review and trend identification.
- Intermediate medical writing skills and medical terminology.
- Basic planning/project management skills (develop short range plans that are realistic and effective).
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 trial designclinical trial executionprotocol developmentICF document developmentdata review plan developmentmedical writingstatistical analysistrend identificationGCPICH
Soft skills
collaborationcommunicationleadershipproject managementplanninginterpersonal skillspresentation skillsorganizational skillsproblem-solvingadaptability
Certifications
MDPhDPharm DMSRN
