About this role
Job title: Senior Director Clinical Operations - Home Based (US)
About the Role The Senior Director, Clinical Operations is a senior leadership position responsible for the strategic planning, tactical execution, and day-to-day management of clinical investigations involving human subjects. The role ensures compliance with corporate objectives, regulatory requirements, and global standards such as ICH-GCP, Good Clinical Practice, and local regulations.
What You'll Do
- Develop and execute operational plans for assigned clinical trials, aligning with budget, timelines, and SOPs.
- Oversee recruitment, completion, and budgeting of R&D-sponsored trials within timelines.
- Oversee local CRAs and vendor oversight for sponsored trials.
- Plan and execute clinical trial goals, ensuring compliance with quality and timelines.
- Represent local regions in global study team meetings, providing feedback and insights.
- Ensure timely submission and approval of ethical and administrative submissions for in-house studies.
- Monitor site performance, feasibility, and study execution for assigned trials.
What We're Looking For
- Bachelor's degree in life sciences or related field (advanced degree preferred).
- Extensive experience in clinical operations within pharmaceutical, biotechnology, or CRO industries.
- Ability to manage complex, multi-site trials across global regions.
- Proven track record of leading and managing clinical trials from start to finish.
- Non-malignant hematology experience; Von Willebrand disease experience required.
- Strong understanding of regulatory requirements and GCP guidelines.
- Excellent communication, leadership, and problem-solving skills.
- Willingness to travel approximately 20%.
- Must be legally authorized to work in the United States without sponsorship for employment visa status.
Compensation & Benefits
- Competitive salary and benefits. Benefits include: annual leave entitlements, health insurance offerings to suit you and your family’s needs, retirement planning offerings, Global Employee Assistance Programme LifeWorks (24-hour access to a global network of over 80,000 independent professionals), life assurance, flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.