Clinical Scientist Team Lead, Cellular Therapy Process

Bristol Myers Squibb New York City , NY 10008

Posted 3 weeks ago

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.

Division

R&D / Global Drug Development

Cell Therapy

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.

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Clinical Scientist Team Lead, Cellular Therapy Process

Bristol Myers Squibb