Bristol-Myers Squibb Company

P&E Lead

Princeton, NJ, US
May 14, 2018
Required Education
Position Type
Full time

Wallingford Transition

Planning and Execution Lead, Global Biometric Sciences

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 either to the Head of Planning and Vendor Management or a D7.2 PE lead.

Primary Responsibilities:
• 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:
o Drives the development and maintenance of the Development Team's Book of Work
o 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.
o Tracks progress against plans, collects metrics data, and proactively identifies operational risks/issues and remediation
o 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:
o Develops, reviews and gains approval of outsource contract documents (e.g., request for proposals, work orders, change orders)
o 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.
o Coordinates the review and acceptance of vendor deliverables and approves vendor invoices for payment
o 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

Success Factors:
Effectively demonstrates fully functioning capability in the follow areas:

BMS Core Behaviors:
o Leads Strategically
o Drives Performance
o Innovates
o Embraces Teamwork
o Communicates Directly
o Develops and Energizes People

GBS Leadership Success Factors:
o Leading and Managing Change
o Influence and Impact Relationships
o Decision Making
o Building a Learning Environment
o Emotional Intelligence
o Managing and Developing Performance

Note: Please refer to ancillary document for definitions and descriptions of aforementioned success factors

• 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:
o Statistical, medical, and clinical trials knowledge
o Project management skills

Primary Stakeholders:
Stakeholder Area of Focus
Development Team • Communicates GBS project BoW status
• Represents GBS at SSC
• Participates in CDT
• Co-Lead of Data Team
GBS Lead and functional managers • Validates project plan and deliverables
• Contributes to identifying and managing project resources and make assignments
• Partners for coaching and feedback
GBS project team • Develops and communicates work plan and status
• Prioritizes GBS tasks and assigns resources to tasks
• Recommends and gains agreement on approaches to remediate deviations from approved project plans
Study Steering Committee • Communicates project status and ensures any issues identified are tracked to resolution
PBO • 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
Vendor staff • Primary project team communication
• Day-to-day management and monitoring progress against timelines
• Provides feedback on performance
• Coordinates review and acceptance of deliverables
• Approves invoices for payment