Executive Director – Operations Lead

Jobtailor

Massachusetts

On-site

USD 150,000 - 210,000

Full time

3 days ago

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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

Manage clinical trials and programs across the product life cycle
Create, execute, and proactively manage clinical trial processes from study planning through close-out
Define tactics and manage daily operational activities to meet timelines and deliverables
Provide leadership, strategic oversight, and guidance to Clinical Operations
Establish performance indicators for successful clinical trial execution
Integrate clinical operations expertise into Clinical Development activities, development plans, and study protocols
Review CRO proposals and budgets and participate in CRO selection
Review and negotiate investigator grant budgets
Represent Clinical Operations to the Executive Committee, Project Teams, Board of Directors, and internal stakeholders
Lead, mentor, train, and support the professional development of Clinical Operations staff
Oversee quality checks and compliance with SOPs, ICH-GCP guidelines, regulations, and patient safety standards
Mentor staff on regulatory inspections and inspection readiness
Assist QA with developing, reviewing, and updating clinical SOPs
Author operational sections of protocols and investigator brochures
Identify and interact with investigative sites and investigators
Maintain relationships with CROs, external experts, and investigators
Coordinate with Biometrics on clinical data deliverables
Support regulatory submissions, dossier development, and interactions with FDA, EMA, and other agencies
Monitor competitive regulatory and clinical practices and adjust plans accordingly

Requirements

Bachelor’s in Life Sciences, Nursing Licensure, or Pharmacy
Minimum of 10 years of experience in clinical operations development and strategic planning
Experience developing, implementing, and leading early- to late-stage clinical trials
In-depth understanding across the clinical operations value chain
Track record in study planning, execution, data cleaning, database locking, study report generation, and regulatory inspection
Relevant therapeutic area experience
Experience with pivotal, multi-site, multinational clinical trials
Experience with global drug development and NDA filing
Experience developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory, and safety documents
Experience collaborating with cross-functional teams to meet study deliverables on time and on budget
Advanced degree (MS or PharmD) preferred

Core Competencies

Demonstrates expertise in managing clinical trials and programs throughout the product life cycle, with a strong focus on strategic planning, regulatory compliance, and operational excellence. Proven ability to lead cross-functional teams and mentor staff while ensuring adherence to industry standards and timelines.

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