Senior Director, Clinical Operations & Trials Leadership

Jobtailor; Massachusetts; On-site; USD 150,000 - 210,000; Full time

Job summary

Jobtailor is seeking a senior Clinical Operations leader to manage trials across the product life cycle, from study planning through close-out, in Massachusetts.

You will provide leadership, strategic oversight, and guidance to Clinical Operations, establish performance indicators, and coordinate with CROs, Biometrics, and regulatory teams.

This role demands 10+ years in global drug development, NDA filings, protocol and SOP development, and a proven ability to deliver on time and on budget.

Qualifications

• Bachelor’s in Life Sciences, Nursing Licensure, or Pharmacy required.
• Minimum 10 years in clinical operations development and strategic planning.
• Experience with pivotal, multi-site, multinational trials.
• Experience with global drug development and NDA filing.
• Advanced degree (MS or PharmD) preferred.

Responsibilities

• Manage clinical trials and programs across the product life cycle.
• Create, execute, and manage clinical trial processes from planning through close-out.
• Provide leadership, strategic oversight, and guidance to Clinical Operations.
• Establish performance indicators for successful trial execution.
• Coordinate with CROs, Biometrics, and regulatory teams to ensure timely deliverables.
• Lead, mentor, and develop Clinical Operations staff.
• Oversee SOPs, ICH-GCP compliance, and patient safety standards.
• Assist with regulatory submissions, dossiers, and interactions with FDA/EMA.
• Interact with investigators and sites to maintain trial progress and quality.

Skills

Clinical Trial Processes

Study Planning

Protocol Development

SOP Development

Regulatory Submissions

Data Cleaning

Database Locking

Clinical Study Reports

NDA Filing

Investigator Budget Management

Leadership

Mentoring

Communication

Team Collaboration

Problem Solving

Education

Bachelor’s in Life Sciences

Nursing Licensure

Advanced degree (MS or PharmD) preferred

Job description

Jobtailor is seeking a senior Clinical Operations leader to manage trials across the product life cycle, from study planning through close-out, in Massachusetts.

You will provide leadership, strategic oversight, and guidance to Clinical Operations, establish performance indicators, and coordinate with CROs, Biometrics, and regulatory teams.

This role demands 10+ years in global drug development, NDA filings, protocol and SOP development, and a proven ability to deliver on time and on budget.