Compound Operations Lead

Compound Operational Lead (COL)

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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

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