Associate Director, Clinical Operations/Country Manager

Are you a seasoned leader in clinical operations with a passion for driving innovative medical research? Do you thrive in a dynamic, globally-minded environment, ready to make a significant impact on studies focused on rare diseases and oncology? Precision Medicine Group invites you to step into a pivotal role as our Associate Director, Clinical Operations/Country Manager. This is your chance to shape the future of clinical trials, providing expert leadership for our operations in South Korea, all while being a vital part of a fully remote team that’s revolutionizing precision medicine worldwide.

Overview

Precision for Medicine, a leading Clinical Research Organization, is uniquely positioned at the forefront of precision medicine. We integrate novel clinical trial designs, unparalleled operational and medical expertise, sophisticated biomarker and data analytics, and an unwavering commitment to advancing treatments, particularly in rare diseases and oncology, alongside other critical therapeutic areas. Our continued expansion creates an exciting opportunity for an Associate Director, Clinical Operations/Country Manager to guide our Clinical Operations Department (Clinical Trial Management and Clinical Monitoring). While this is a remote position, candidates should be based in South Korea to effectively manage country specific responsibilities. You will play a crucial role in ensuring the delivery of top-quality, timely, and cost-effective clinical trial operations, all in strict compliance with ICH-GCP, federal regulations, our Standard Operating Procedures, and other relevant guidelines. This leadership position involves collaborating closely with executive management, contributing meaningfully to the ongoing development of our Clinical Operations Department, and shaping our business plan both tactically and strategically.

Key Responsibilities

Provide comprehensive leadership and mentorship to the Clinical Operations Department, including Clinical Trial Management and Clinical Monitoring teams.
Oversee and ensure the execution of high-quality, timely, and budget-conscious clinical trial operations.
Maintain stringent compliance with ICH-GCP guidelines, applicable federal regulations, internal SOPs, and all other pertinent regulatory requirements.
Collaborate actively with executive management on strategic initiatives for the continuous enhancement and evolution of the Clinical Operations Department.
Contribute significantly to the development and implementation of tactical and strategic business plans.
Manage country-specific operational aspects, ensuring smooth execution and adherence to local regulations and cultural nuances.
Drive process improvement initiatives within clinical operations to optimize efficiency and quality.

Requirements

A minimum of 8+ years of progressive experience in clinical operations, including significant leadership roles within a Clinical Research Organization (CRO) or pharmaceutical company.
Demonstrated expertise in managing clinical trials, particularly in rare diseases and/or oncology.
Profound understanding and application of ICH-GCP principles, global regulatory requirements, and standard operating procedures.
Proven ability to lead, motivate, and develop high-performing clinical operations teams.
Exceptional strategic planning, problem solving, and decision-making capabilities.
Strong communication and interpersonal skills, essential for cross-functional collaboration and stakeholder engagement.
Fluency in both English and Korean is highly preferred, given the country manager responsibilities in South Korea.
A Bachelor's degree in a life science or a related health discipline is required; advanced degree is a plus.

What You'll Gain

An opportunity to lead and innovate within a pioneering organization at the cutting edge of precision medicine.
Work with a team deeply committed to transforming patient lives through groundbreaking research, especially in challenging areas like rare diseases and oncology.
Significant professional growth and development in a leadership role with strategic influence.
Be part of a supportive, collaborative, and fully remote global team environment.
Competitive compensation and benefits package reflecting your expertise and impact.
The chance to contribute to a company culture that values scientific rigor, operational excellence, and a genuine passion for our mission.