Director, GCO Clinical Program Lead (GCPL)
J
JobgetherClinical Operations
Remote work environment within the United StatesFull-TimeDirector
SalaryAnnual base salary: $171,900–$231,900
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Job Details
- Experience
- 10+ years of experience in the clinical trial industry
- Required Skills
- Stakeholder managementBudgeting
Requirements
- Bachelor’s degree or higher in a scientific, healthcare, or related discipline.
- 10+ years of experience in the clinical trial industry.
- Extensive experience managing the full lifecycle of multi-region or multinational clinical trials.
- Demonstrated experience in both clinical program management and people leadership.
- Deep knowledge of ICH/GCP guidelines and applicable clinical research and regulatory requirements.
- Experience managing complex programs across multiple countries, functions, vendors, and stakeholder groups.
- Strong leadership and coaching capabilities, with a demonstrated ability to build high-performing teams.
- Excellent strategic thinking, analytical, organizational, and problem-solving skills.
- Strong executive communication and stakeholder-management skills.
- Experience with MS Office, project planning applications, and Clinical Trial Management Systems (CTMS).
- Ability to balance long-term program strategy with hands-on operational oversight.
- Willingness and ability to travel domestically and internationally, up to approximately 20%.
Responsibilities
- Provide strategic operational leadership for designated global clinical development programs, overseeing study delivery, performance, quality, timelines, budgets, and operational KPIs.
- Lead, develop, mentor, and retain Global Clinical Study Managers, including hiring, onboarding, performance management, resource planning, and career development.
- Serve as the primary escalation point for complex study and compound-related issues, driving timely and effective resolution.
- Partner with program and franchise leadership to establish clinical operations strategies, priorities, standards, and performance measures.
- Represent Clinical Operations in governance forums and provide operational insight that informs program strategy and execution plans.
- Support KOL engagement activities and act as a clinical operations spokesperson.
- Evaluate strategic feasibility and budget estimates, ensuring appropriate resources and study structures are established.
- Oversee the creation, review, and maintenance of compound-level and study documentation, including investigator materials, safety reports, and protocols.
- Conduct regular program reviews to assess study progress, risks, budgets, timelines, and quality indicators.
- Support vendor selection, governance, performance management, and global vendor strategy.
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