Clinical Scientist Late Development/Global Drug Development

Profile

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.

Summary

Work closely with clinical team members within the assigned project to execute assigned activities associated with the conduct of a clinical trial

May lead or support trial level activities for one or more trials with a moderate to high level of supervision.

Responsibilities include, but are not limited to:

Literature review

Support the development of Protocol and ICF documents / amendments

Submission of clinical documents to TMF

Support the development of site and CRA training materials

Review clinical narratives

Review clinical data, issue and resolve data queries

Review clinical data for specific trends as instructed

Review and validation of Clinical Study Reports with guidance

Review of annual reports (e.g., annual safety reports, Investigator Brochures, etc)

Support study committee (e.g., DMC) logistics and presentation development

Attend study team meetings and collaborate cross functionally with study team members

Interface with others for scientific and functional guidance

Seek out and enact best practices with instruction

Provide regular and timely updates to manager

Job Requirements

Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations

Ability to understand assigned protocol(s) and their requirements

Detail-oriented with commitment to quality

Basic knowledge and skills to support program specific data review and trend identification

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 medical writing skills and medical terminology

Intermediate critical thinking & 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)

Basic planning/project management skills (develop short range plans that are realistic and effective

Moderate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)

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)

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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com