Director / Sr. Director Product Team Leader

BRIS 1.015

Summary

The Product Team Leader (PTL) will have responsibilities for leading an interdisciplinary product team in driving the creation and execution of the global development plan. In this role, the PTL will expected to drive the execution of deliverables across all functional areas involved in the Project Team

Responsibilities

• Direct the development of innovative product team strategies and plans to maximize the likelihood of clinical, regulatory, and commercial success
• Foster positive and effective working relationships between product team members
• Communicates program team-level changes and request for changes through appropriate escalation
• Responsible for program operating budgets within the team including the monitoring and control of team-level expenditures and variances to budget
• Regularly interface with the UNITY Executive team and potential collaborators to provide project updates and strategy recommendations
• Lead in the analysis and interpretation of data and reporting of results
• Responsible for program timelines and program status reporting
• Proactively identify project issues before they arise and develop contingency plans
• Conducts program-level risk planning, management and mitigation
• Interact with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders
• Collaborate with any development partners to ensure aligned strategies and systems that allow for holistic data analysis as well as global health authority reporting requirements

REQUIREMENTS:

• Previous experience with program leadership, management systems, and methodology
• Multi-faceted background with experience working with functions from multiple groups including Research, Development, CMC, Commercial/Marketing, Regulatory, Safety Pharmacology, Toxicology
• Familiarity with Health Authorities and regulatory filings
• Comprehensive knowledge in the overall pharmaceutical drug development process, from discovery through post-marketing authorization
• Demonstrated ability to systemically move diverse teams to decisions and recommendations and drive resolution of issues while maintaining positive working relationships across functions