This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Clinical Operations based in the United States.
This senior leadership role sits at the center of clinical development execution, overseeing the operational strategy and delivery of early-phase clinical studies.
You will drive end-to-end clinical operations activities, ensuring studies are executed efficiently, compliantly, and aligned with sponsor objectives.
The role combines strategic oversight with hands-on leadership across CROs, vendors, and cross-functional study teams.
You will play a critical part in shaping study design inputs, operational planning, and executional excellence across Phase I programs.
A strong focus is placed on quality, regulatory compliance, and alignment with ICH/GCP and global regulatory standards.
You will collaborate directly with sponsors, internal stakeholders, and external partners to ensure timelines, budgets, and deliverables are met.
This is a high-impact role where your leadership directly influences the success of early clinical development programs.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Clinical Operations based in the United States.
This senior leadership role sits at the center of clinical development execution, overseeing the operational strategy and delivery of early-phase clinical studies.
You will drive end-to-end clinical operations activities, ensuring studies are executed efficiently, compliantly, and aligned with sponsor objectives.
The role combines strategic oversight with hands-on leadership across CROs, vendors, and cross-functional study teams.
You will play a critical part in shaping study design inputs, operational planning, and executional excellence across Phase I programs.
A strong focus is placed on quality, regulatory compliance, and alignment with ICH/GCP and global regulatory standards.
You will collaborate directly with sponsors, internal stakeholders, and external partners to ensure timelines, budgets, and deliverables are met.
This is a high-impact role where your leadership directly influences the success of early clinical development programs.
Accountabilities:
- Lead clinical operations and study management activities across Phase I clinical development programs.
- Oversee CRO and vendor selection, including scope development, budgets, timelines, and contractual agreements.
- Provide strategic and operational oversight of clinical trial execution from start-up through database lock and reporting.
- Ensure studies are conducted in compliance with SOPs, ICH/GCP guidelines, and applicable regulatory requirements.
- Collaborate with QA teams to support audits, review quality systems, and maintain inspection readiness.
- Drive study planning activities including timelines, metrics, resource allocation, and budget oversight.
- Review and contribute to key clinical study documents such as protocols, IBs, INDs, and informed consent forms.
- Manage vendor performance, invoices, and change orders while ensuring alignment with project objectives.
- Oversee data quality processes including discrepancy management and eCRF review.
- Contribute to clinical operations quality systems, SOP development, and process improvements.
- Provide leadership, mentoring, and communication across study teams and stakeholders to ensure project alignment and execution.
- Bachelor’s degree in life sciences or related scientific discipline required; advanced degree preferred.
- 15+ years of experience in clinical research, CRO, pharmaceutical, or biotechnology environments.
- Strong expertise in Phase I clinical development and early clinical operations.
- Proven experience managing CROs, vendors, and cross-functional clinical study teams.
- Deep knowledge of ICH/GCP guidelines, regulatory requirements (FDA, EMA), and clinical compliance standards.
- Experience with clinical trial budgets, contracts, vendor agreements, and financial oversight.
- Strong leadership skills with the ability to manage complex, multi-disciplinary programs.
- Excellent communication, stakeholder management, and cross-functional collaboration skills.
- Strong analytical thinking, problem-solving ability, and attention to detail in fast-paced environments.
- Proficiency in MS Office and familiarity with project management tools and clinical systems.
- Preferred: prior experience managing direct reports and developing SOPs or clinical quality systems.
- Competitive executive-level compensation package (aligned with experience and market standards)
- Comprehensive medical, dental, and vision insurance coverage
- Retirement savings plan with employer contributions
- Paid time off, holidays, and flexible work arrangements
- Career development opportunities within a global clinical research environment
- Exposure to innovative early-phase drug development programs
- Collaborative, science-driven, and mission-focused work culture
- Opportunities to work with leading sponsors and global clinical stakeholders