Clinical Science Lead

2 weeks ago

Brisbane, United States Bristol-Myers Squibb Full time

**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
- 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)

**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 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
- Domestic and International travel may be required

**For California based role**

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