Program Lead, Clinical Delivery - FSP

When our values align, there's no limit to what we can achieve. At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Job Overview

The purpose of the Program Lead, Clinical Delivery is to lead the creation and execution of the exploratory and biopharmaceutics clinical development plans at a molecule level, with technical leadership and operational oversight of clinical research trials within the development plan.

The Program Lead, Clinical Delivery is responsible for planning and delivering exploratory and biopharmaceutics clinical trial and submission milestones on time and on budget throughout the molecule lifecycle.

The Program Lead, Clinical Delivery is responsible for all aspects of global clinical trial operations within the plan, as the single operational point of contact for trials from design through execution, including timeline creation and management, outsourcing plan, vendor management (including oversight of the operational deliverables), and budget management.

The Program Lead will seek knowledge from internal and external sources and use this information to shape development plans and continuous improvement opportunities. 1.

Scientific and Therapeutic Area Expertise Leads the development of the clinical asset strategy for phase 1 leveraging quality decision making principles. Understands assigned therapeutic area including trial designs, risks and execution challenges and best practices.

Provides consultation to the project team for clinical and regulatory documents such as study protocols, Investigator Brochures (IBs), risk prof