Senior 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.

Position Summary / Objective

Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more trials

Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision

Provides scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership)

Co-Leads study team meetings in partnership with GDO protocol manager; and collaborate with cross functional study team members

May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning)

Position Responsibilities

Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members

Plan and lead the implementation all study startup/conduct/close-out activities as applicable

Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)

Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)

Site-facing activities such as training and serving as primary contact for clinical questions

Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team

Clinical data trend identification; provide trends and escalate questions to Medical Monitor

Develop clinical narrative plan; review clinical narratives

Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.

Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities

Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)

Collaborate and serve as primary liaison between external partners for scientific advice

Degree Requirements

Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)

Experience Requirements

5 years of experience in clinical science, clinical research, or equivalent

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

Proficient knowledge and skills to support program specific data review, trend identification, data interpretation

Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees

Key Competency Requirements

Excellent verbal, written, communication and interpersonal skills

Must be able to effectively communicate and collaborate across functions and job levels

Ability to assimilate technical information quickly

Routinely takes initiative

Detail-oriented

Strong sense of teamwork; ability to lead team activities

Proficient in Medical Terminology and medical writing skills

Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)

Proficient critical thinking, problem solving, decision making skills

Understanding of functional and cross-functional relationships

Commitment to Quality

Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism

Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)

Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting 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.

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