Associate Director, Clinical Operations – Late-Phase

Role Overview

• Define and implement the operational strategy for assigned clinical trials, in collaboration with the cross-functional team and clinical leadership.
• Provide expertise into the development of clinical documents (eg., study protocols and amendments, investigator brochures, case report forms, informed consent forms, study plans, site manuals, etc.).
• Author portions of clinical documents as required.
• Develop and manage trial timelines to ensure alignment with overall program objectives and milestones.
• Effectively manage trial communication to ensure stakeholders are informed of and aligned on trial activities and progress.
• Proactively identify, communicate, and manage risks that may affect trial milestones, quality, or budget.
• Identify and select qualified vendors.
• Responsible for vendor performance management.
• Perform co-monitoring, as required, to support site, vendor and trial oversight.
• Ensure clinical studies are conducted in compliance with SOPs, ICH/GCP guidelines, and FDA regulations.
• Oversee and ensure high quality of clinical trial execution and trial data.
• Oversee and direct clinical contractors, as required.
• Oversee and ensure accuracy of clinical trial budgets.
• Oversee accruals reporting and forecasting for assigned trials.
• Review vendor invoices for accuracy.
• Contribute to Clinical Operations resource and budget planning.
• Contribute to the development of department SOPs, systems, policies, best practices, and standards that support high quality clinical trial execution and GCP inspection readiness.
• May manage direct reports, including ongoing performance management, mentorship, and career development.

Requirements

• Bachelor’s Degree in life sciences
• 8 years relevant industry experience

• 3 years of experience on acute and/or chronic pain studies.

• Proficient knowledge of ICH GCP, CFR, and other applicable regulatory requirements for clinical trial conduct.
• Prior experience directing and managing Phase 2 and Phase 3 clinical trials.
• Prior experience with pain or analgesia trials preferred but not required.
• Prior experience with resource, budget, and vendor management.
• Demonstrated critical thinking, problem solving, and negotiation skills
• Demonstrated ability to successfully work in cross-functional project teams with an emphasis on teamwork, collaboration, and communication.
• Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders (e.g., scientific advisors, clinical consultants, CROs, investigators).
• Self-disciplined, detail-oriented, and able to prioritize tasks to meet critical deadlines.

Tech Stack

• Google Cloud Platform