Director / Senior Director, Clinical Operations
Our client is working with cytokine therapeutics for transformational immunotherapies in oncology and autoimmune disease. As the company progresses multiple programs through early- and mid-stage clinical development, they are seeking an experienced Clinical Operations leader who can step in seamlessly, own execution, and elevate operational excellence across their portfolio.
This Director / Senior Director–level Clinical Operations leader will play a critical role in driving study planning, oversight, vendor management, trial execution, and cross-functional alignment. Thorough Group is proud to support our client in identifying a seasoned professional who thrives in dynamic biotech settings, brings structure to ambiguity, and ensures programs advance with precision, quality, and urgency.
Key Responsibilities:
Clinical Trial Leadership
- Lead global clinical trial execution across Phase I–II programs, ensuring timelines, quality, budget, and compliance targets are consistently achieved.
- Provide hands-on oversight of key study activities including startup, enrollment strategy, monitoring, safety reporting, data review, and study close-out.
- Serve as the operational point of contact for internal teams, investigators, and external partners.
CRO & Vendor Oversight
- Manage CROs and critical vendors, ensuring deliverables, KPIs, and quality metrics are met.
- Lead vendor governance meetings and proactively address risks, resourcing, and performance gaps.
- Support contract reviews, SOW development, and budget planning.
Cross-Functional Collaboration
- Partner closely with Clinical Development, Biometrics, Regulatory, CMC, Clinical Supply, Quality, and Medical Monitor functions to align on strategy, timelines, and operational execution.
- Facilitate communication flow between internal and external stakeholders to ensure issues are rapidly identified and resolved.
Operational Excellence & Inspection Readiness
- Drive operational discipline through robust documentation, audit-ready processes, and GCP-compliant execution.
- Contribute to process optimization, study-level governance, risk assessment, and continuous improvement initiatives.
- Anticipate inspection risks and ensure ongoing readiness.
Strategic Input & Planning
- Provide strategic input on program development plans, feasibility, site strategy, and operational forecasting.
- Support scenario planning and mitigation strategies for enrollment, site performance, supply chain, and vendor dependencies.
Qualifications
- 10+ years of Clinical Operations experience within biotech or pharmaceutical companies, with recent leadership in early-phase development.
- Proven track record overseeing global clinical trials, managing CROs, and leading cross-functional execution.
- Deep knowledge of GCP, ICH guidelines, and global regulatory expectations.
- Ability to operate autonomously, make informed decisions, and manage multiple priorities in a fast-moving environment.
- Strong communicator with exceptional organizational skills and a collaborative mindset.
- Experience in oncology, immunology, or biologics strongly preferred.