Associate Director/Director Clinical Operations

Associate Director / Director, Clinical Operations

Overview

We are partnering with an emerging, well-funded biotechnology company seeking an experienced Associate Director / Director of Clinical Operations to support a growing portfolio of both early- and late-stage clinical programs. This is a high-impact role offering the opportunity to contribute strategically while also building and leading clinical operations capabilities as the pipeline advances.

This individual will play a key role in the execution and oversight of global clinical trials, working cross-functionally to ensure studies are delivered on time, within budget, and in compliance with regulatory standards. As the organization continues to scale, this position offers clear leadership growth and the ability to shape processes, vendors, and team structure.

Key Responsibilities

• Provide operational leadership across clinical trials from study start‑up through close‑out, spanning early‑ and late‑phase programs
• Oversee CROs and external vendors to ensure high‑quality execution and adherence to timelines and budgets
• Drive study planning activities including protocol input, timelines, resource planning, and risk mitigation strategies
• Collaborate cross‑functionally with Clinical Development, Regulatory, Data Management, and other key stakeholders
• Establish and refine clinical operations processes, systems, and best practices in a growing biotech environment
• Ensure compliance with GCP, SOPs, and applicable regulatory requirements
• Support inspection readiness and participate in audits as needed
• Mentor and/or manage junior team members as the function expands

Qualifications

• Bachelor’s degree required; advanced degree preferred
• 8+ years (Associate Director) or 10+ years (Director) of clinical operations experience within biotech/pharma
• Experience managing clinical trials across multiple phases (early and/or late stage)
• Demonstrated ability to work in a fast‑paced, evolving environment with increasing levels of responsibility
• Prior experience in a small or mid‑sized biotech setting is highly preferred
• Proven leadership capability or clear trajectory toward people management

What Makes This Opportunity Compelling

• Broad exposure across both early‑ and late‑stage clinical development
• Opportunity to step into a leadership role with real influence on team build and strategy
• High‑visibility position within a collaborative and agile organization
• Onsite presence fostering close interaction with executive leadership and cross‑functional teams