Bristol Myers Squibb Company

Clinical Scientist Cell Therapy

Location
Celgene, NJ, United States
Posted
Sep 13, 2020
Ref
R1523168
Required Education
Doctorate/PHD/MD
Position Type
Full time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Position Summary / Objective

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

Position Responsibilities

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.)

Degree 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)

Experience Requirements

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)

Key Competency Requirements

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)

Travel Required

Domestic and International travel may be required.

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 the resources to pursue their goals, both at work and in their personal lives.