Associate Director of Clinical Operations

*** AD of Clinical Operations Opportunity - Boston ***

QP Group has been exclusively partnered with a global Phase 3 Oncology biotech who are developing new cancer therapeutics with it's lead program in head and neck cancer.

• Lead Sponsor-side clinical operations for the global Phase 3 study and other assigned programs, with responsibility for high-quality, timely execution from study start-up through closeout.
• Lead Sponsor oversight of CROs and specialized vendors, serving as the primary operational contact and ensuring accountability for timelines, quality, monitoring, deliverables, budgets, contractual commitments, and timely resolution of study and site issues.
• Drive study planning and execution, including operational feasibility, integrated study plans, timelines, milestones, metrics, critical paths, risk management, decision tracking, and timely escalation and resolution of operational issues.
• Lead global country and site execution, including country and site selection, feasibility, qualification, activation, enrollment planning, site performance and remediation, while building effective relationships with investigators and site teams.
• Translate the protocol into effective operational execution, ensuring alignment of the protocol and Schedule of Activities across eCRFs, IRT, laboratory, imaging, radiotherapy, pharmacy, pathology, biomarker, safety, and data-management plans and systems.
• Partner closely across Clinical Development, Medical, Clinical Science/Translational Medicine, Safety, Data Management, Biostatistics, Regulatory, Quality, and CMC/Clinical Supply, ensuring coordinated execution and timely operational implementation of medical, scientific, safety, and functional decisions.

• 7+ years of clinical operations experience in biotechnology or biopharma, with significant responsibility for global clinical trials. Direct leadership experience in a global Phase 3 oncology study is strongly preferred.
• Demonstrated experience successfully managing outsourced CRO-led clinical trials and specialized vendors, ideally within a small or emerging biotechnology company.
• Strong oncology experience preferred. Experience in head and neck cancer, neuro-oncology/GBM, immuno-oncology, or complex multimodality trials is particularly valuable.
• Strong working knowledge of ICH/GCP, global regulatory requirements, risk-based quality management, and current ICH E6 principles, with experience supporting audits, inspections, and regulatory filings.
• Familiarity with clinical data review and major clinical trial systems, including EDC, CTMS, eTMF, IRT, eCOA, and safety/data-review platforms.
• BS/BA/RN in a life science or health-related field preferred; an advanced degree is desirable. Ability to travel up to 25% domestically and internationally.