|Category||Project Management||Job type||Full-Time|
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 ofBDS deliverables on one or more development projects, including program planning, project management, oversight and coordination of internalBDS 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 BDS, with external vendors, and the cross-functional Development Team. This role reports either to the Head of Planning and Vendor Management or a D7.2 or D8 PE lead.
Provides leadership for ensuring quality in the planning and execution of the BDS project team's work
Utilizes project management competencies to support the BDS 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 BDS Lead and functional managers.
Tracks progress against plans, collects metrics data, and proactively identifies operational risks/issues and remediation
Represents BDS project team at Study Steering Committee meetings and project planning/tracking meetings
Manages relationships and interactions with BDS 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 BDS 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 BDS 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 BDS project team's work. This person will enable the success of the BDS project team by:
Planning and management of project deliverables, BDS resources and the project Book of Work
Ensuring compliance with regulatory guidelines and BMS/BDS policies and standards
Ensuring alignment and transparent communication of scope and status of BDS work to project specific business partners (e.g. GCR, Development Lead, GMA)
Enhancing the effectiveness and value of our vendors by adhering to BDS standards for managing vendor interactions
Effectively demonstrates fully functioning capability in the follow areas:
BMS Core Behaviors
Develops and Energizes People
BDS 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
Stakeholder Area of Focus
Represents BDS at SSC
Participates in CDT
Co-Lead of Data Team
BDS Lead and functional managers
Contributes to identifying and managing project resources and make assignments
Partners for coaching and feedback
BDS project team
Prioritizes BDS tasks and assigns resources to tasks
Recommends and gains agreement on approaches to remediate deviations from approved project plans
Study Steering Committee
A point of contact for communication with project team
Receives global resource allocation and prioritization of work at the enterprise level
Provides updates, escalation, status and metrics.
Provides vendor contract information, vendor assessment and issue escalation
Day-to-day management and monitoring progress against timelines
Provides feedback on performance
Coordinates review and acceptance of deliverables
Approves invoices for payment
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.