Contact: Linda Aronova – laronova@penfieldsearch.com

Primary Responsibilities: Provides leadership for ensuring quality in the planning and execution of the GBDS project team’s work

• Utilizes project management competencies to support the GBDS 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 GBDS Lead and functional managers.
• Tracks progress against plans, collects metrics data, and proactively identifies operational risks/issues and remediation
• Represents GBDS project team at Study Steering Committee meetings and project planning/tracking meetings
• Manages relationships and interactions with GBDS 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 GBDS 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 GBDS 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 GBDS project team’s work. This person will enable the success of the GBDS project team by:

• Planning and management of project deliverables, BDS resources and the project Book of Work
• Ensuring compliance with regulatory guidelines and company/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

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