Clinical Science Lead - Brisbane, United States - Bristol-Myers Squibb

Bristol-Myers Squibb

Verified Company

Brisbane, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Working with Us
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 rich in diversity.

Take your career farther than you thought possible.

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

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

Key Responsibilities

Collaborate with Clinical Science Program Lead 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 Science Team on the Program 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
Sitefacing 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)

Qualifications & Experience

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 selfsupervise, 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 daytoday challenges with confidence and professionalism
Proficient planning/project management skills (ability to develop short to midrange 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
Domestic and International travel may be required