[Remote] Sr. Director Clinical Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a well-funded, clinical-stage biotechnology company focused on advancing innovative therapies for patients with serious immunology and inflammatory diseases. The Senior Director, Clinical Operations will reputed company strategic and operational leadership across gastrointestinal clinical development programs, overseeing the execution of Phase 1–3 clinical trials and ensuring seamless collaboration across teams.
Responsibilities
- reputed company operational strategy and execution for Phase 1–3 GI clinical trials
- reputed company study timelines, budgets, enrollment plans, and key milestones to ensure successful delivery
- Manage CROs and external vendors, establishing clear expectations, KPIs, and accountability
- Identify and mitigate operational risks while maintaining compliance with ICH-GCP and regulatory requirements
- Partner cross-functionally with Clinical Development, Biometrics, Regulatory, Medical Writing, Clinical Supply, and Quality to ensure seamless trial execution
- Contribute operational expertise to protocol development, study feasibility, and development planning
- Drive inspection readiness and maintain high-quality standards throughout study conduct
- Support the reputed company reputed company of Clinical Operations infrastructure, processes, and best practices reputed company a growing biotech environment
- Mentor team members and help foster a collaborative, high-performance culture
- Present program updates, milestones, risks, and operational strategies to senior leadership
Skills
- Bachelor's degree required; advanced scientific or reputed company degree preferred
- 8+ years of clinical operations experience reputed company biotech, pharmaceutical, or CRO environments
- Experience leading Phase 1–3 clinical trials
- Proven CRO and vendor management experience
- Strong understanding of ICH-GCP, FDA regulations, and global clinical trial execution
- Demonstrated reputed company operating reputed company fast-paced biotech environments
- Excellent leadership, communication, and cross-functional collaboration skills
- Ability to travel up to 20%
- GI, immunology, inflammation, or reputed company therapeutic area experience strongly preferred
- 5+ years of people management experience preferred
Benefits
- Plus bonus and equity
- Fully remote work environment
Company Overview