Director Clinical Operations

Kennedy Bond; Boston (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Kennedy Bond is partnering with a clinical-stage precision oncology biotech to recruit an Associate Director or Director, Clinical Operations. You will join a growing Clinical Operations team and own global oncology studies across strategy and delivery.

This role requires leadership of CROs and vendors, with strong regulatory knowledge and cross-functional collaboration across Regulatory, Data Management, Biostatistics, and Clinical Development. Boston-area preferred.

Qualifications

• 8+ years of experience in Clinical Operations across biotech/pharma/CRO environments.
• Experienced in leading global oncology clinical trials and study delivery.
• Strong knowledge of ICH-GCP and global regulatory requirements.

Responsibilities

• Lead global oncology clinical trials from study start-up through closeout.
• Own the operational strategy and delivery of assigned studies.
• Serve as Clinical Operations point of contact across internal teams, CROs and vendors.
• Manage CRO and vendor performance across timelines, budgets and quality.
• Identify study risks and develop mitigation strategies.
• Track study KPIs and risk-based quality management.
• Collaborate with Clinical Development, Regulatory, Data Management and Biostatistics.

Skills

Clinical Operations

Global oncology trials

Vendor management

Regulatory compliance

Job description

Kennedy Bond is partnering with a clinical-stage precision oncology biotech on a retained search for an Associate Director or Director, Clinical Operations.

This individual will join a growing Clinical Operations team and take ownership of global oncology studies as the company continues to advance multiple programs through clinical development. The role will have significant responsibility across study strategy, operational delivery, CRO and vendor oversight, and cross-functional collaboration.

Candidates based in the Greater Boston area or across New England are strongly preferred.

Key Responsibilities:

• Lead global oncology clinical trials from study start-up through closeout
• Own the operational strategy and delivery of assigned clinical studies
• Serve as the primary Clinical Operations point of contact across internal teams, CROs, and external vendors
• Manage CRO and vendor performance across timelines, budgets, quality, and study deliverables
• Identify study risks proactively and develop appropriate mitigation strategies
• Track study performance through KPIs, metrics, and risk-based quality management
• Partner closely with Clinical Development, Regulatory, Data Management, Biostatistics, and other cross-functional stakeholders
• Contribute to regulatory submissions, audits, inspections, and inspection readiness activities

Requirements:

• 8+ years of experience within Clinical Operations across biotech, pharmaceutical, and/or CRO environments
• Strong experience leading global oncology clinical trials
• Demonstrated experience managing CROs and vendors within an outsourced clinical development model
• Strong knowledge of ICH-GCP, FDA regulations, EU CTR, and global clinical trial requirements
• Experience working within a clinical-stage biotech environment is strongly preferred
• Experience supporting inspection readiness activities

This is an opportunity to join a well-funded precision oncology biotech at an important stage of development, with the ability to take meaningful ownership of clinical programs and work closely with a highly experienced team as the pipeline continues to progress.