Director of Clinical Operations

Job Title: Director of Clinical Operations

Job Number: 36308

Location: Cambridge, MA

Job Description

In this role you will lead the planning, execution, and oversight of oncology clinical trial programs.  

Responsibilities

• Direct and manage the daily clinical operations of the company’s research programs, including contributions to protocol development and key study documentation.

• Collaborate closely with the CMO and R&D team to gather and integrate scientific and medical insights that inform clinical development strategies, study designs, and protocol content.

• Design and execute operational strategies for clinical trials, encompassing timelines, budgets, and resource planning.

• Provide oversight and guidance in preparing the clinical sections of regulatory submissions.

• Contribute to the creation of clinical documents such as protocols, Investigator’s Brochures (IBs), Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and related materials.

• Lead protocol implementation efforts, ensuring coordination with vendors and clinical sites, and confirming the operational feasibility of study designs.

• Support the evaluation, selection, and oversight of Clinical Research Organizations (CROs), investigators, and clinical sites.

• Supervise data management processes, including the monitoring, documentation, and reporting of adverse events.

• Foster strong working relationships with CROs, vendors, and clinical sites to meet study milestones while proactively identifying and addressing risks or issues.

• Contribute to building and maintaining a robust clinical operations infrastructure that ensures ongoing inspection readiness.

• Ensure adherence to regulatory requirements, industry standards, and Good Clinical Practice (GCP) guidelines.

• Lead cross-functional teams to manage clinical trial timelines and ensure the successful execution of deliverables.

Required Skills

• Bachelor’s, Master’s, or advanced degree in a scientific discipline with 10+ years of experience in clinical operations.

• At least 5 years of hands-on experience in early-phase (Phase 1–2) oncology drug development, including direct involvement in IND preparation and submission activities; experience with protein therapeutics is preferred.

• Proven track record of leading complex clinical programs and cross-functional initiatives, with expertise in both short- and long-term operational planning, governance, and oversight.

• Strong background in managing oncology clinical trials, with a deep understanding of oncology-specific endpoints and strategies to maintain data integrity.

• Demonstrated ability to manage multiple high-priority projects simultaneously, including budgeting and prioritization.

• Thorough knowledge of industry standards, regulatory expectations, and clinical development guidelines.

• Skilled in preparing for and supporting regulatory submissions and inspections.

• Comprehensive understanding of GCP, GLP, and GMP regulations and their application in clinical development.

• Experience in developing and implementing Clinical Operations standard operating procedures (SOPs) and performance metrics.

• Exceptional leadership capabilities with a proven ability to guide, motivate, and support cross-functional teams.

• Strong interpersonal, communication, organizational, and problem-solving skills.