Senior Director, Head of Clinical Programs

Role Overview

• The Senior Director, Clinical Programs provides strategic leadership and oversees global clinical development operations for designated programs and assets within the Therapeutic area.
• This role involves building strong relationships with internal and external stakeholders, ensuring alignment with senior leaders, and leveraging clinical and regulatory intelligence to drive innovation.
• The Senior Director is responsible for the overall CRO & Clinical Partnership strategy, leading clinical development aspects of Due Diligence, Integration, and Business Development, and overseeing multiple programs.

Requirements

• 18+ Years experience in Clinical Operations managing global clinical studies/programs across therapeutic areas.
• Skilled at clinical project management across multiple projects in a fast-paced environment, including ability to develop robust study budget.
• Intimate knowledge of ICH
• Good Clinical Practice (GCP) and other worldwide regulations applicable to the conduct of clinical research.
• Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations.
• Experienced in key Clinical Operations principles, concepts, practices, standards, processes, and tools.
• Experience in outlining Clinical operations strategy and ensuring effective delivery.
• Effectively transitions between strategy and operational execution, with the adaptability to modify plans as required based on changes in priority.
• Experience in building high performing teams through talent development and coaching, developing honest relationships, and generating trust by demonstrating consistency between words and actions.
• Experienced in working with multidisciplinary groups and ability to work within a globally located cross functional and cross-cultural team environment.
• Significant experience in managing and developing relationships with Service Providers used to support execution of clinical research (e.g., Contract Research Organisations (CROs)), as well as in working in a hybrid outsourcing model with strategic providers (FSO/FSP model).
• Capable of addressing issue escalation and governance needs between internal and external teams in a partnership manner.
• Experience in compiling and overseeing clinical study budgets, including benchmarking study/site costs and financial control criteria related to purchase orders, invoice checking, and milestone deliverables defined in clinical trial agreements and/or CRO service agreements (SOW).

Tech Stack

• Google Cloud Platform

Benefits

• Our teams are passionate about what they do because they care about making a difference in patients’ lives.
• We invest in our employees to support life-changing projects that create positive impact for patients and society.