Clinical Science Team Lead

Profile

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Job Title

Team Lead Clinical Scientist

Division

R&D / Global Drug Development

Location

Princeton Pike or Summit or San Diego

Grade

D08

Direct Reports

Yes

Direct Manager

Clinical Scientist Program Lead, Gastroenterology & Neurology

Functional Area Description

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.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Company: Bristol-Myers Squibb

Req Number: R1527647_EN

Updated: 2020-07-13 00:00:00.000 UTC

Location: San Diego,California

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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

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