Senior Director managing execution of clinical trial programs to advance gene therapy. Leading clinical operations, ensuring strategic execution, and mentoring clinical teams across multiple clinical programs.
JJ
Hybrid Director, Trials and Research Excellence – Global Medical Affairs
Posted last month
About the role
- Director of Trials and Research Excellence at Johnson & Johnson focusing on evidence generation plans. Collaborates globally to implement medical affairs standards and optimize research activities.
Responsibilities
- Driving delivery of Worldwide Integrated Evidence Generation Plans (WWIEGP) and studies
- Implement and maintain, in collaboration with cross functional and regional partners, WW Research Standards, processes, and templates for strategy and planning of Interventional & Non-Interventional Prospective Medical Affairs Research Studies
- Support implementation of WW Standards through partnership with disease area aligned Medical Affairs Research Teams (MARTs) and input to the supporting operating model
- Support WWIEGP annual process as well as ongoing portfolio study management
- Proactively identify and manage issues that impact budget, timelines or quality delivery of evidence generation projects
- Deliver corrective plans/approval for adjustment
- Execute metrics to track and communicate medical and business impact of WW IEGP Enabling Capabilities
- Identify key areas for artificial intelligence in enhancing and enabling worldwide evidence generation activities
- Ensure AI and other solution developments and successful implementation through roll out of relevant training to J&J Medical Affairs Worldwide Governance
- Support optimization of WW IEGP prioritization criteria and assessment process
- Partner with relevant legal/HCC functions to review and revise or create new Evidence Generation SOPs
- Partner with PADU to create metrics to monitor IEGP study milestones and ensure studies conducted to optimal speed and cost efficiency
Requirements
- Minimal of a master's degree or higher Degree, PhD or MD
- 5+ years of relevant experience in a medical/clinical or scientific environment/ pharmaceutical experience
- Previous experience of designing and achieving approval of clinical trials, developing and executing evidence generation plans
- Previous Medical Affairs experience preferred
- Demonstrated AI capabilities and previous experience of deploying technology solutions
- Demonstrated leadership ability to successfully work across functional and geographic boundaries, preferably across multiple countries/market types/access models is required.
- Strong collaboration/matrix management, influencing, strong communication skills (both written and oral)
- Process excellence, project management and strong organizational skills required
- Demonstrated learning agility and the ability to effectively influence portfolio strategies based on insights and foresights to future scientific direction is required
- Understanding of Pharma R&D process in high innovation environment is required
- Proven strategic thinking and strategic commercial skills across product and lifecycle is required
- Global mindset with proven ability to partner cross culturally and regionally is required
- Ability to drive projects forward to completion through planning and organizational skills
- Approximately 10% Travel Domestic and International
- 3 years people management experience is required
Benefits
- Inclusive work environment
- Career development opportunities
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Degree requirement
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