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