Clinical Science Program Lead - Cellular Therapy

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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


Partners with Clinical Scientist Head to plan, lead, and advance programs and talent
Serves as a member of the Clinical Science Leadership Team and Development Team
Supports resource forecasting, talent development, succession planning and retention strategies
Defines and standardizes best practices and development opportunities for the scientist team
Builds a collaborative, supportive learning environment
Ensures and contributes to a consistent and high level of training for Clinical Scientists across the department with respect to relevant scientific data and knowledge, including SOPs and Working Practices
May serve as a delegate of Clinical Scientist Head as needed
Partners with the Clinical Development Lead accountable for the assigned program; supports activities required to develop clinical development and lifecycle management plans

Leads/manages a team or complex scope of work to ensure high quality delivery of innovative protocols and data packages for CSRs and Regulatory Filings
Oversees all clinical studies within assigned program(s) to ensure consistency across program(s)
Ensures high quality and timely delivery of protocols and data; implements quality assurance plans
Maintains an advanced understanding of the status of all trial activities within assigned Program
Provides scientific and clinical leadership to support the team; provide program/study/therapeutic area/skills training to team members
Attends Development Team meetings as needed
Leads resourcing and budget planning activities for team
Holds accountability for the performance and professional development of Clinical Scientist team
Leads proactive risk identification and mitigation plans; provides progress reports and risk assessment updates to Sr. Management
Reviews and approves clinical contributions to all trial documents / abstracts / publications
Reviews, audits, and presents data and information to internal leaders and external investigators
Serves as a key cross functional collaborator; represents the Clinical Scientist function in various process improvement initiatives and/or cross functional activities
Collaborates to support incoming asset and/or business development activities (i.e., due diligence)

Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)

15 years of experience in clinical science, clinical research, or equivalent within the hematology/oncology space
Experience and demonstrated proficiency in managing direct/indirect employees and leading teams

Demonstrates deep understanding Clinical Research and Development in hematology/oncology. Experience with cellular therapy, bone marrow transplant or gene therapy a plus.
Advanced knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
Recognized internally and externally as a Functional/Technical expert
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
Ability to self-supervise, and act independently to identify/resolve program level issues
Proficient critical thinking, problem solving, decision making skills
Advanced oral and written communication skills, including medical writing, presentations to large groups, facilitation of interactive discussions and 1:1 discussion with internal and external thought leaders
Strong leadership presence
Expert financial acumen
Commitment to Quality
Adaptable / Flexible
Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally
Promotes a culture of scientific excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality and effective communication
Anticipates needs, assesses and manages business and organizational risks


Domestic and International travel may be required.

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 the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1525403_EN

Updated: 2020-05-15 00:00:00.000 UTC

Location: Jersey City,New Jersey

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.

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