Clinical Scientist, Early Development

Bristol Myers Squibb•Madison, CA

2d•$150,770 - $210,110

About The Position

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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. Read more: careers.bms.com/working-with-us . The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs. 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).
Appropriate for new entrance to pharma (post fellowship/ new to industry)
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)
Detail-oriented with commitment to quality
Basic knowledge of disease area, compound, current clinical landscape
Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
Intermediate critical thinking and problem-solving skills
Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)
Domestic and International travel may be required.

Responsibilities

Design and execution of assigned clinical trial activities
Work closely with clinical team members within the assigned project to execute activities associated with the conduct
Serve as Clinical Trial Lead for one or more trials
Lead or support trial level activities for one or more trials with the necessary supervision
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.)

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume