Job Details

Associate Director, Planning & Execution Lead, Global Biometric Sciences

Clinical Dev

icon-location-marker Princeton - NJ - US
Posted 54 days ago Full_time R1547184

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.

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 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 to a Director level 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

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

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 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
      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

#GBDS

#GBDSP&E

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. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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