Therapeutic Strategy Director – Early Clinical Development

Job Overview

Early Clinical Development is a core, complex focus at IQVIA, requiring deep expertise and integrated data-driven strategies. The Therapeutic Strategy Leader (TSL) serves as the scientific and strategic lead responsible for designing differentiated development strategies for sponsors from First-in-Human (FIH), dose-finding, biomarker development, through Phase IIa studies. The role combines therapeutic expertise, clinical development knowledge, operational strategy, and business development support.

The ideal candidate is an experienced, consultative leader responsible for driving early engagement and proposals aligned with client needs in collaboration with the business development and other stakeholders. TSL will serve as a therapeutic and operational strategy expert throughout the new business and program/project delivery lifecycle to increase IQVIA's therapeutic market share with early engagement and innovative strategic responses to proposals.

Responsibilities

Business Growth and Client Engagement: Leverage IQVIA medical, scientific, operational and data science experts to determine the optimal solution, project design and lead a cross-functional team in proposal development through to award. Assigned to take ownership of developing client-centric solutions, designing both strategic and methodological approaches to ensure that IQVIA secures client projects. Champion and advocate the IQVIA Connected Intelligence solutions and include existing and new innovative solutions as applicable and appropriate through the sales process.

Strategy Development: As a leader of the pre-award strategy team, TSL is accountable and responsible for creation of innovative, effective, and compelling therapeutic and operational strategies that client differentiates IQVIA from its competitors. Work with key internal stakeholders and pre/post-award teams to analyze information and data that enables development of efficient and feasible delivery solutions. This may include, but is not limited to, protocol feasibility and risk management, assessment and management of the competitive landscape, optimal country and site distributions, site and patient recruitment strategies, monitoring and vendor strategies.

Actively support Sales in the preparation and conduct of client and bid defense meetings e.g. training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys project strategy and critical win themes. Attend and present at client meetings, or bid defense meetings, as required. Recommend site, country, and patient recruitment strategies appropriate for early-phase studies. Leverage ECD networks, Phase I units, specialist investigators, and therapeutic expertise to improve execution.

Strategy Translation and Post Award Support: Translate the sold strategy to the delivery team and be an available resource for the delivery team when changes to strategy are required. Provide post award strategy guidance and support to delivery teams if in-flight studies require changes to strategy.

Required Knowledge, Skills and Abilities

• Remain up to date with knowledge and information that supports effectiveness as a Therapeutic Strategy Lead e.g. understanding IQVIA's services, tools and product offerings, status and trends in early clinical development, innovations and advances in clinical trial methodology, and business intelligence.
• Broad protocol and therapeutic knowledge.
• Comprehensive global knowledge, awareness, and practical understanding of the biopharma industry, drug development lifecycle and operational clinical trial delivery.
• Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic areas.
• Strong leadership skills, critical thinking, ability to work with minimal supervision, and lead a virtual team in a matrix organization.
• Flexible and able to work in situations where specifications may or may not be well defined and willing to support work in other therapeutic areas when required.
• Confident and capable in the use of technology, applications, and other media e.g. databases and internet to research new opportunities, maintain currency of therapeutic and operational knowledge, and competitive landscape.

Minimum Required Education and Experience

• Bachelor's Degree in life sciences, advanced degree preferred, with extensive knowledge of Early Clinical Development in multi therapeutic areas.
• 10 years and above global clinical research experience, including hands on Phase I operational delivery and/or drug development experience.
• Proven track record in operational delivery and/or drug development; or equivalent combination of education, training and experience.
• Must have extensive experience with Clinical Operations and Clinical Project Management.
• Experience in early clinical development is required, including—but not limited to—areas such first-in-human, dose-finding, healthy-volunteers and in patient Phase I studies.