Associate Director Clinical Operations

Role Summary

Seeking a strategic, execution-focused Clinical Operations leader to drive end-to-end delivery of a Phase 2 CKD study. This role combines big-picture program thinking with hands-on study ownership — overseeing CROs and vendors, accelerating enrollment and site performance, safeguarding data quality and compliance, and collaborating cross-functionally to support overall clinical development objectives.

Core Responsibilities

Study Leadership

• Direct Phase 2 study execution from protocol development through final CSR

• Lead enrollment planning, forecasting, and site engagement initiatives

• Contribute to clinical program strategy through participation on cross-functional development teams

• Support KOL engagement, advisory boards, and patient advocacy interactions alongside Clinical Science

CRO, Vendor & Site Management

• Provide day-to-day oversight of CROs, vendors, and investigative sites

• Lead vendor selection, contract negotiations, and budget discussions

• Establish performance metrics (KPIs) and governance frameworks

Financial Management

• Oversee clinical study budgets and ensure efficient use of resources

Quality & Compliance

• Maintain data integrity and ensure adherence to protocols, SOPs, and ICH-GCP

• Partner with QA to support inspection readiness

Operational Excellence & Innovation

• Contribute to scalable processes and operational best practices

• Assess and implement clinical systems and tools (eTMF, CTMS, RBM, etc.)

• Explore innovative technologies (including AI/ML and analytics) to enhance trial execution

Cross-Functional Collaboration

• Work closely with Clinical Development, Regulatory, Data Science, CMC, and Supply Chain

• Provide input into broader program decisions beyond individual study delivery

Leadership Expectations

• Clear communicator and strong cross-functional partner

• Drives accountability, execution, and proactive risk management

• Supports team development and promotes high operational standards

Qualifications

Required

• Bachelors degree in a scientific or health-related field

• 8–10+ years of Clinical Operations experience

• Leadership of Phase II–III clinical trials

• Experience in common and/or rare disease drug development

• Solid knowledge of FDA, EMA, and ICH-GCP requirements

• Experience with clinical trial systems (e.g., Medidata Rave, Veeva)

• Clinical budgeting, forecasting, and vendor oversight experience

• Strategic mindset with ability to influence at study and program level

• Thrives in a fast-paced, growth-stage environment

• Strong communication skills

• Ability to travel up to ~30%

Preferred

• Program-level leadership and mentoring experience

• Prior people management experience (small teams)

• Experience using technology to drive clinical trial efficiency