Associate Director / Director, Clinical Operations
Location: Hybrid - Maryland
We are partnering with an innovative oncology biotechnology company seeking an Associate Director / Director, Clinical Operations to lead and drive clinical programs from pre-IND through all phases of development.
This role will provide strategic and operational leadership across clinical studies, partnering closely with cross-functional teams to ensure successful trial execution while supporting process improvements and operational excellence.
Key Responsibilities
- Lead and oversee global clinical studies from start-up through completion
- Develop and execute clinical operational strategies alongside Clinical and Project Leads
- Manage study timelines, budgets, resources, vendors, and CRO relationships
- Lead cross-functional collaboration across Clinical, Regulatory, Medical, Quality, Finance, and related teams
- Mentor and develop Clinical Operations team members
- Drive study start-up activities, patient recruitment initiatives, and operational process improvements
- Monitor study progress, milestones, and financial performance while ensuring compliance and inspection readiness
What We're Looking For
- Bachelor's degree (or equivalent) with 8+ years of biotech/pharma experience
- 4+ years of clinical project management experience (level determined by experience)
- Strong understanding of ICH, GCP, and regulatory requirements
- Experience working in cross-functional matrix environments
- Life sciences or medical background required
- Oncology experience preferred
- Previous CRA experience highly desirable
Up to 20% travel required
#J-18808-Ljbffr