Associate Director, Clinical Operations (Contract)

As an Associate Director, Clinical Operations, you will provide strategic and operational leadership across clinical trials throughout the development lifecycle.
You will oversee study execution from start-up through close-out, ensuring milestones, budgets, quality standards, and regulatory requirements are met.
The role combines hands-on clinical operations expertise with cross-functional leadership and vendor management.
You will work closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Safety, and external partners.
Your oversight will help identify risks early, maintain study momentum, and support high-quality trial execution across domestic and international programs.
The position offers the opportunity to contribute to the development of innovative medicines for neurological and sleep-related conditions.
This is a remote, contract-to-hire opportunity with occasional travel and the potential to transition into a permanent role.

• Bachelor’s degree in a scientific field required; an advanced degree is preferred.
• 8+ years of experience within pharmaceutical, biotechnology, or CRO environments.
• Proven experience managing clinical trials across multiple phases, including Phase 1–3 studies and domestic and international programs.
• Experience supporting global clinical trials is preferred.
• Strong working knowledge of clinical trial operations, global regulatory requirements, ICH guidelines, and GCP.
• Solid understanding of clinical development project management, including timelines, resources, budgets, risks, and operational dependencies.
• Demonstrated experience overseeing CROs, vendors, and other external partners.
• Experience using clinical trial management systems.
• Prior experience supporting FDA regulatory submissions is a plus.
• Experience in CNS and/or sleep disorders is preferred.
• PMP certification or formal project management training is a plus.
• Demonstrated ability to lead and influence cross-functional teams without direct authority.
• Strong communication, collaboration, and interpersonal skills, with the ability to work effectively across technical and non-technical functions.
• Highly organized and capable of managing multiple priorities in a fast-paced clinical development environment.
• Creative, adaptable, and solutions-oriented approach to challenges involving timelines, quality, resources, and budgets.
• Proactive problem-solving mindset with the ability to anticipate needs, take initiative, and implement practical solutions.
• Strong attention to detail and commitment to maintaining quality, compliance, and inspection readiness.