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.
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 BDS deliverables on one or more development projects, including program planning, project management, oversight and coordination of internal BDS 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
gt;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
Development Team • Communicates BDS project BoW status
Represents BDS at SSC
Participates in CDT
Co-Lead of Data Team
BDS Lead and functional managers • Validates project plan and deliverables
Contributes to identifying and managing project resources and make assignments
Partners for coaching and feedback
BDS project team • Develops and communicates work plan and status
Prioritizes BDS 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
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
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.
**Company:** Bristol Myers Squibb
**Req Number:** R1531948
**Updated:** 2021-09-18 02:45:29.035 UTC
**Location:** San Diego,California
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.