Therapeutic Strategy Director – Early Clinical Development

About the role

IQVIA's Early Clinical Development is a core, complex focus, and the Therapeutic Strategy Leader (TSL) acts as the scientific and strategic lead for sponsors, from First-in-Human and dose-finding through Phase IIa studies. Working from home in the USA, the TSL designs differentiated development strategies, leads proposal development and cross-functional teams, and takes ownership of high-level client relationships, working closely with the sales and account team.

Key responsibilities

• Lead proposal development through to award, using IQVIA's medical, scientific, operational and data science experts to define the optimal solution and project design.
• Advocate IQVIA's Connected Intelligence solutions and propose stand-alone programs, RFIs, capabilities and early engagement opportunities.
• Create innovative therapeutic and operational strategies that differentiate IQVIA from competitors, working with internal and pre/post-award teams.
• Analyze data on protocol feasibility, risk management, competitive landscape, country and site distribution, site and patient recruitment, monitoring and vendors.
• Support sales in client and bid defense meetings, train the project team, and attend and present at client and bid defense meetings.
• Recommend site, country and patient recruitment strategies for early-phase studies and leverage ECD networks, Phase I units and specialist investigators.
• Translate the sold strategy to the delivery team and give post-award guidance when studies require strategy changes.

Required profile

• Bachelor's degree in life sciences, advanced degree preferred, with extensive knowledge of early clinical development across multiple therapeutic areas.
• 10+ years of global clinical research experience, including hands-on Phase I operational delivery and/or drug development.
• Extensive experience in Clinical Operations and Clinical Project Management.
• Experience in early clinical development, including first-in-human, dose-finding, healthy volunteer and in-patient Phase I studies.

Required skills

• Broad protocol and therapeutic knowledge, and comprehensive understanding of the biopharma industry and drug development lifecycle.
• Strong leadership, critical thinking and ability to lead a virtual team in a matrix organization with minimal supervision.
• Ability to work in situations with unclear specifications and to support other therapeutic areas when needed.
• Confident use of databases and the internet to research opportunities and stay current on therapeutic and competitive knowledge.