Company name
Bristol-Myers Squibb Company
Location
Princeton, NJ, United States
Employment Type
Full-Time
Industry
Manager, Pharmaceutical
Posted on
Jun 11, 2020
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.
Purpose
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.
Primary Responsibilities
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.
Impact
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
Success Factors
Effectively demonstrates fully functioning capability in the follow areas:
BMS Core Behaviors
Leads Strategically
Drives Performance
Innovates
Embraces Teamwork
Communicates Directly
Develops and Energizes People
BDS Leadership Success Factors
Leading and Managing Change
Influence and Impact Relationships
Decision Making
Building a Learning Environment
Emotional Intelligence
Managing and Developing Performance
Education/Experience
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
Primary Stakeholders
Stakeholder Area of Focus
Development Team
Communicates BDS project BoW statusRepresents BDS at SSCParticipates in CDTCo-Lead of Data TeamBDS Lead and functional managers
Validates project plan and deliverablesContributes to identifying and managing project resources and make assignmentsPartners for coaching and feedbackBDS project team
Develops and communicates work plan and statusPrioritizes BDS tasks and assigns resources to tasksRecommends and gains agreement on approaches to remediate deviations from approved project plansStudy Steering Committee
Communicates project status and ensures any issues identified are tracked to resolutionA point of contact for communication with project teamReceives global resource allocation and prioritization of work at the enterprise levelProvides updates, escalation, status and metrics.Provides vendor contract information, vendor assessment and issue escalationVendor staff
Primary project team communicationDay-to-day management and monitoring progress against timelinesProvides feedback on performanceCoordinates review and acceptance of deliverablesApproves invoices for paymentBristol-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: R1523182_EN Updated: 2020-03-17 00:00:00.000 UTC Location: Princeton,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.
Company info
Bristol-Myers Squibb Company
Website : http://www.bms.com