Director of Clinical Operations (Boston)

Director of Clinical Operations
Onsite-4 days a week (Boston, MA)
$200,000-$230,000
Position Summary
Reporting directly to the Chief Medical Officer, the Director of Clinical Operations will lead the planning, execution, and oversight of our oncology clinical trials. This role combines strategic leadership with hands-on operational management, ensuring studies are delivered on time, on budget, and in compliance with regulatory and Good Clinical Practice (GCP) standards. The ideal candidate will be a skilled communicator and collaborator, comfortable working with both internal leadership and external partners.
Key Responsibilities

• Lead and manage daily operations of clinical studies, including protocol development and preparation of study documentation.
• Collaborate closely with the CMO and R&D teams to integrate scientific and clinical insights into trial design and execution.
• Design and implement operational strategies aligned with study goals, timelines, budgets, and resource needs.
• Drive the development and submission of clinical components for regulatory filings.
• Author or review clinical trial protocols, investigator brochures, informed consent forms, clinical study reports, and other core documents.
• Oversee site selection, vendor engagement, and feasibility assessments to ensure successful study implementation.
• Manage CROs, clinical trial sites, and other external partners to maintain study quality and performance.
• Monitor trial progress, data integrity, and safety reporting, including adverse event tracking.
• Foster strong partnerships with external vendors and internal teams to address challenges proactively and meet milestones.
• Support the development of scalable operational infrastructure to ensure audit and inspection readiness.
• Ensure strict adherence to regulatory requirements and GCP guidelines.
• Lead cross-functional teams to achieve trial objectives and resolve operational barriers.

Qualifications & Experience

• Bachelor's or Master's degree in a scientific discipline with 10+ years in clinical operations.
• At least 5 years of experience in early-phase oncology (Phase 1-2), including contributions to IND submissions.
• Preferably experienced in protein-based therapeutics.
• Proven leadership in managing complex clinical programs and cross-functional initiatives.
• Deep understanding of oncology clinical trial execution, including endpoint strategy and data quality management.
• Expertise in project planning, budgeting, and resource coordination.
• Strong knowledge of clinical trial regulations, GCP, GLP, and GMP standards.
• Demonstrated experience in regulatory submissions and inspection readiness.
• Skilled in developing SOPs and operational metrics for clinical trial management.
• Effective communicator with strong organizational and problem-solving abilities.
• Collaborative, proactive leader capable of guiding diverse teams in a fast-paced environment.

• This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

INDBH #J-18808-Ljbffr