Clinical Scientist Team Lead

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.

The Clinical Scientist Team Lead reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs.

Position Summary / Objective

Leads the Clinical Science team in the planning and execution of clinical trial activities to support the Clinical Development Plan for the disease/indication team

Manages and supervises a team of senior and junior Clinical Scientists to execute trial level activities for multiple trials

Ensures consistency across studies and provide oversight of all clinical studies within assigned area

May serve as a Clinical Trial Lead or Co-Lead as needed

May represent the Clinical Scientist function in various process improvement initiatives and/or cross functional activities

Serves as a key cross functional collaborator; initial point of escalation cross functions

Position Responsibilities

Collaborate with Program Lead Scientist and Clinical Development Lead to support development of clinical development and lifecycle planning

Lead implementation of assigned clinical development and/or lifecycle plans

Maintain an advanced understanding of all protocols within assigned Program

Provide scientific and clinical leadership to support all activities to advance the assigned plans; Provide program/study/therapeutic area/skills training to team members

Represent Clinical Scientist Team on the Development Team as appropriate/requested

Support resourcing and budget planning activities for team

Review and present data and information to external investigators and internal stakeholders as needed

Identify and liaise with internal and external collaborators independently and oversee collaboration between clinical scientist and external partners for scientific advice

Lead proactive risk identification and mitigation at indication level; provide progress reports and risk assessment updates to Sr. Management

Author/Review abstracts/publications

Oversee, contribute to, and ensure quality execution of deliverables for all phases of assigned trials (start up/conduct/closure), through activities such as:

Evaluation of innovative trial designs

Protocol and ICF development

Site-facing activities

CRA training materials

Data quality activities; ensure consistent, quality data review across trial teams

Investigator Meetings, SIVs, Advisory Board, and Study committee (e.g., DMC) activities

Clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)

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

Experience in driving, managing and collaborating in a team/matrix work environment

Recognized internally and externally as a Therapeutic Area and Functional expert

Key Competency Requirements

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

Ability to plan and manage

Advanced ability to analyze, interpret, and present data

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

Advanced knowledge of indication, therapeutic area, compound(s), competitive landscape and health authority requirements

Advanced medical writing and presentation skills

Ability to self-supervise, and act independently to identify/resolve program level issues

Proficient critical thinking, problem solving, decision making skills

Effective planning and time management

Advanced verbal, written and interpersonal skills (communication skills)

Adaptable and analytical

Strong presentation skills / leadership presence

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