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.
This position manages the Biometric processes of drug development projects including key aspects such as clinical trials reporting and regulatory filing activities. This position is responsible for the strategic planning and execution of GBS deliverables on one or more development projects, including program planning, project management, oversight and coordination of internal GBS resources and vendor activities, metrics tracking and compliance with regulatory requirements/guidelines and corporate/departmental policies, procedures and standards. This role has significant interfaces within GBS, with external vendors, and the cross-functional Development Team. This role reports to a D7.2 PE lead.
Provides leadership for ensuring quality in the planning and execution of the GBS project team’s work
Utilizes project management competencies to support the GBS project team including:
Drives the development and maintenance of the Development Team’s Book of Work
Develops, gains alignment and implements project plans (e.g. activities, deliverables, timelines, resources, work assignments) that are aligned with the Development Team’s approved objectives and timelines with input from GBS Lead and functional managers.
Tracks progress against plans, collects metrics data, and proactively identifies operational risks/issues and remediation
Represents GBS project team at Study Steering Committee meetings and project planning/tracking meetings
Manages relationships and interactions with GBS vendors at the project level including:
Develops, reviews and gains approval of outsource contract documents (e.g., request for proposals, work orders, change orders)
Monitors vendor performance and proactively identifies issues and risks with their work. When necessary, escalates issues and risks to the Planning and Business Operations group for action.
Coordinates the review and acceptance of vendor deliverables and approves vendor invoices for payment
Provides feedback on vendor performance and contributes to “Lessons Learned” for community of PE Leads contributing to an environment of continuous improvement
Provides timely coaching to team members and performance feedback to functional managers
Ensures project team is compliant with regulatory requirements and guidance, corporate and departmental procedures and standards. Identifies potential compliance issues within GBS project team (e.g. knowledge gaps) and partners with functional management to remediate
Serves as Co-Lead for the Data Team; participates in CDT
Educates self and others about the clinical aspects of the asset and the core operational issues.
Acts as a key project team interface back into the GBS PBO organization (metrics, resources, vendor relationships)
Supports, contributes to, and potentially leads continuous improvement initiatives.
May potentially manage and develop other PE leads as direct reports.
The PE Lead will provide focused attention on critical planning and drive the efficient execution of the GBS project team’s work. This person will enable the success of the GBS project team by:
planning and management of project deliverables, GBS resources and the project Book of Work
ensuring compliance with regulatory guidelines and BMS/GBS policies and standards
ensuring alignment and transparent communication of scope and status of GBS work to project specific business partners (e.g. GCR, Development Lead, GMA)
enhancing the effectiveness and value of our vendors by adhering to GBS standards for managing vendor interactions
Effectively demonstrates fully functioning capability in the follow areas:
BMS Core Behaviors
Develops and Energizes People
GBS Leadership Success Factors
Leading and Managing Change
Influence and Impact Relationships
Building a Learning Environment
Managing and Developing Performance
Graduate degree and/or relevant experience in statistics, biostatistics, mathematics, computer science or business administration
>7 years of Pharmaceutical/R&D or other related experience in a regulated environment
Experience managing the programming and/or statistical aspects of clinical trials reporting for regulatory filings and market access
Vendor management experience
Functional Success Criteria
Statistical, medical, and clinical trials knowledge
Project management skills
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.