Director of Clinical Operations - Astrix : Job Details

Join to apply for the Director of Clinical Operations role at Astrix

16 hours ago Be among the first 25 applicants

Join to apply for the Director of Clinical Operations role at Astrix

Get AI-powered advice on this job and more exclusive features.

Position SummaryReporting 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.

Director of Clinical OperationsOnsite-4 days a week (Boston, MA)$200,000-$230,000Position SummaryReporting 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.

• 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

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  IT Services and IT Consulting

Referrals increase your chances of interviewing at Astrix by 2x

Sign in to set job alerts for Director Clinical Operations roles.

Director / Sr Director, Clinical Business Operations

Boston, MA $175,000.00-$190,000.00 2 weeks ago

Boston, MA $208,200.00-$327,140.00 2 days ago

Senior Director, Clinical Operations/Development

Head (Executive Director) Rare Disease, US Medical Affairs

Boston, MA $260,000.00-$285,000.00 2 weeks ago

Senior Director, Clinical Business Operations

Associate Director, Clinical Business Operations

Director, Clinical Operations, Oblenio Bio

Cambridge, MA $225,000.00-$245,000.00 3 days ago

Associate Director, Clinical Business Operations

Senior Director, Head of In-Country Clinical Study Operations Americas

Regional Director of Clinical Operations

Sr. Director Clinical Operations/Program Lead 2074235

Director/Sr. Director, Clinical Operations

Concord, MA $120,000.00-$140,000.00 2 weeks ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.