Head, Program and Study Management - Non-Oncology

Responsibilities Contribute to the development and execution of the GCTO vision, strategy, and goals. Serve as the GCTO point of accountability for the assigned TA(s). Translate scientific and TA objectives into robust operational strategies. Full accountability for the operational planning, execution, and delivery of the clinical program portfolio. Ensure proactive cross-functional collaborations to develop robust trial delivery strategies. Provide senior oversight for all phases of clinical trial management. Drive alignment of CtQ factors at program level. Act as the primary escalation point for resolving complex operational issues. Ensure all activities are conducted in compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable global regulatory requirements. Build organizational talent and create a work environment for teams and individuals to reach their full potential. Champion the modernization of clinical trial operations. Requirements Bachelor's degree required with a concentration in a scientific-related discipline strongly preferred. Advanced scientific degree (Master's, PharmD, PhD) in life sciences, medicine, or a related field strongly preferred. Minimum of 12 years of progressive experience in the pharmaceutical, biotechnology, or CRO industry, with a primary focus on clinical trial operations and drug development. Demonstrated track record of single-point accountability for the successful execution of clinical programs, including pivotal registration trials and regulatory submissions. Proven history of building robust talent pipelines, implementing structured mentorship/rotational programs, and cultivating future directors and program leaders. Expertise in the designated TA with understanding of the specific operational challenges of the TA. Proven experience implementing digital solutions (AI, automation and predictive analytics) to modernize clinical operations. Demonstrated success managing organization budgets, optimizing resource allocation, and reducing costs while accelerating cycle times. Strong knowledge of GCP/ICH and global regulatory expectations. Exceptional executive presence with the ability to break down silos, influence without direct authority, and drive alignment across complex global R&D teams. Core Competencies Demonstrates expertise in clinical trial operations and drug development, with a strong focus on compliance with GCP/ICH guidelines and global regulatory requirements. Proven ability to lead cross-functional teams, drive operational strategies, and modernize clinical operations through digital solutions. Highest-signal resume keywords Clinical Trial Operations Regulatory Submissions GCP/ICH Compliance Digital Solutions Implementation Talent Development ATS Optimization Keywords Hard Skills Clinical Program Management Operational Planning Budget Management Resource Allocation Predictive Analytics Soft Skills Executive Presence Influencing Without Authority Cross-Functional Collaboration Mentorship Industry Keywords Pharmaceutical Industry Biotechnology CRO Industry Life Sciences Tools & Technologies AI Solutions Automation Tools #J-18808-Ljbffr Jobtailor