Kennedy Bond · 2 months ago
Senior Director Clinical Operations
United States
Full-time
Remote
Director/Executive
8+ years expKennedy Bond is a cutting-edge biopharmaceutical company seeking a Clinical Operations Manager / Director to oversee and execute clinical trials across their portfolio. This role involves planning, managing, and executing clinical trials while ensuring adherence to timelines, budget, and regulatory requirements, working closely with various teams and partners to achieve successful trial outcomes.
Staffing & Recruiting
Hiring Manager
Melissa Mallison (Assoc CIPD)
Responsibilities
Oversee clinical trial operations from start-up through closeout for Phase I–III studies
Develop and manage trial budgets, timelines, and resource plans, ensuring efficient use of internal and external resources
Select, manage, and oversee CROs, vendors, and study sites to ensure high-quality data collection and patient safety
Collaborate with cross-functional teams (clinical development, regulatory, medical affairs, biostatistics) to align operational strategies with program goals
Implement and monitor risk-based monitoring and quality management plans to ensure compliance with GCP, SOPs, and global regulatory requirements
Provide leadership and mentorship to clinical operations staff, promoting a culture of excellence, accountability, and continuous improvement
Prepare operational reports, status updates, and presentations for senior leadership and external stakeholders
Qualification
Required
Bachelor's or advanced degree (BS, MS, RN, PharmD) in life sciences, nursing, or a related field
8–12+ years of progressive experience in clinical operations within biotech, pharma, or CRO
Proven experience managing global clinical trials and working with multi-site, multi-country studies
Strong knowledge of GCP, ICH guidelines, FDA/EMA regulations, and clinical trial compliance standards
Experience managing vendors, CROs, and site relationships effectively
Excellent organizational, analytical, and communication skills
Ability to work independently and lead cross-functional teams in a fast-paced, results-oriented environment
Preferred
Experience with eTMF, CTMS, and clinical trial systems
Company
Kennedy Bond
Kennedy Bond specializes in the life sciences search space, forming strategic partnerships with Biotech, Pharmaceutical companies, consulting firms and VC firms across the United States.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase