- 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
- 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)
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)
- 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
- 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
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Clinical Science Lead - Cambridge Crossing, United States - Bristol Myers Squibb
Description
Working with UsChallenging. 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.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 with the resources to pursue their goals, both at work and in their personal lives.
Read more:
The Clinical Science Lead reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs.
The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.
For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.
For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
