Compound Operational Lead (COL)

Job Overview

The Compound Operational Lead (COL) is a global leadership role responsible for providing strategic direction, operational oversight, and end-to-end execution leadership across clinical development programs. Working in close partnership with cross-functional stakeholders, the COL leads operational strategy from First-in-Human (FIH) through regulatory submission and commercialization, ensuring efficient, patient-centric, and high-quality delivery of global clinical programs.

The COL serves as the primary Clinical Operations representative at the program level, driving alignment across functions, managing program complexity, and ensuring delivery against timelines, budgets, quality standards, and corporate objectives. This role requires strong leadership, program management expertise, and the ability to influence decision-making across senior stakeholders and governance bodies.

Key Responsibilities

• Lead operational strategy and execution for complex global clinical development programs spanning multiple studies, indications, and phases of development.
• Serve as the Clinical Operations representative within cross-functional Global Program Teams and governance forums.
• Drive program delivery by ensuring alignment of operational plans, timelines, resources, risks, and budgets across all studies within the assigned program.
• Provide strategic leadership and oversight to Clinical Trial Leads (CTLs) and broader Clinical Operations teams.
• Support preparation and presentation of operational recommendations, risks, mitigations, and key decisions for governance meetings and senior leadership reviews.
• Ensure effective oversight of study and program budgets, forecasts, vendor performance, and resource planning.
• Lead proactive risk identification, issue management, and implementation of corrective and preventive actions (CAPAs).
• Collaborate with internal stakeholders and external partners, including CROs and specialized vendors, to ensure successful program delivery.
• Contribute to the review and development of key clinical development documents including protocols, Clinical Study Reports (CSRs), Investigator Brochures, DSURs, briefing books, and regulatory submission materials.
• Drive continuous improvement initiatives, process optimization efforts, and the implementation of operational best practices.
• Provide coaching, mentorship, and leadership development support to Clinical Operations colleagues and junior operational leaders.
• Ensure compliance with applicable regulations, GCP requirements, company SOPs, and quality standards.

Qualifications

Required Experience

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related discipline. Advanced degree preferred.
• Minimum 10 years of experience within clinical research, clinical development, or clinical operations.
• Significant experience managing global Phase I-IV clinical programs and multi-study development portfolios.
• Demonstrated expertise in clinical project and program management, including budget ownership, forecasting, risk management, and resource planning.
• Proven experience leading cross-functional global teams in a matrix environment.
• Experience with CRO oversight, vendor management, and governance interactions.
• Strong understanding of global drug development processes, ICH-GCP guidelines, and applicable regulatory requirements.
• Experience supporting regulatory submissions and major development milestones is preferred.

Skills & Competencies

• Strong leadership and stakeholder management capabilities.
• Excellent strategic thinking, prioritization, and decision-making skills.
• Demonstrated ability to influence senior leaders and drive alignment across complex organizations.
• Outstanding communication, presentation, and negotiation skills.
• Strong analytical, problem-solving, and organizational abilities.
• Ability to manage competing priorities in a fast-paced global environment.
• Strong financial acumen and budget management experience.
• High level of learning agility, adaptability, and continuous improvement mindset.
• Proficiency with Microsoft Office applications and clinical development systems.
• Excellent written and verbal English communication skills.

Preferred Background

Candidates will typically have prior experience in roles such as:

• Compound Operational Lead (COL)
• Clinical Program Manager (CPM)
• Senior Clinical Program Lead
• Global Clinical Trial Manager (GCTM)
• Clinical Trial Leader (CTL)
• Associate Director, Clinical Operations
• Director, Clinical Operations

This position offers the opportunity to provide strategic leadership across the full lifecycle of clinical development programs and directly influence the successful delivery of innovative therapies to patients worldwide.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.