Associate Director of Clinical Operations – Hematology-Oncology Specialist
Location: Hybrid
Company: Rapidly Growing Biotech Innovating Oncology Therapies
Contract: 6–12 Months (40 hours per week)
Barrington James is partnering with a dynamic biotech company dedicated to advancing oncology therapies. We are seeking a skilled and experienced Associate Director of Clinical Operations to lead Hematology-Oncology (Hem-Onc) studies across all phases of research. This is an opportunity to play a pivotal role in shaping clinical strategy and driving excellence in execution.
Position Summary
As the Associate Director of Clinical Operations, you will oversee multiple studies within the Hem-Onc therapeutic area. This role involves leading clinical trials from start-up to completion, managing cross-functional teams, and ensuring seamless coordination with CROs and vendors. You will also be responsible for clinical operations strategy, ensuring quality and compliance, and driving timely project execution.
Key Responsibilities
- Clinical Oversight: Lead clinical operations for Phase I-IV trials, ensuring protocol adherence and operational excellence.
- Timeline & Quality Management: Maintain oversight of study timelines, deliverables, and quality metrics.
- Vendor Management: Support the selection, oversight, and management of CROs and vendors to optimize performance.
- Feasibility & Capability Assessments: Oversee site feasibility evaluations in collaboration with the CRO and cross-functional teams.
- Risk Mitigation: Proactively identify potential risks and develop robust mitigation plans.
- Budget Oversight: Manage clinical operations budgets, including forecasting, internal reporting, and invoice reviews to ensure alignment with scopes of work.
- Leadership: Manage, mentor, and develop team members, ensuring alignment with organizational policies and regulatory requirements.
- Quality Assurance: Review quality reports, investigate action items, and oversee remediation efforts as needed.
Qualifications
- Education: Bachelor's degree or higher in a life sciences discipline or related field.
- Experience:
- 15+ years in clinical research, with at least 5 years in operations management.
- Demonstrated expertise in Hematology-Oncology clinical studies.
- Knowledge: In-depth understanding of GCP and ICH guidelines.
- Skills: Strong leadership, team management, and communication abilities.
- Flexibility: Willingness to travel as required.
Ready to Make an Impact?
If you’re a leader with a passion for advancing oncology therapies, we’d love to hear from you! Apply today or send your updated CV directly to me at the email address below.