Associate Director, Clinical Operations, CKD

Role Summary

As Associate Director of Clinical Operations, CKD, you will be at the heart of Maze’s APOL1 CKD clinical development strategy, partnering with cross-functional teams to drive lead clinical trial execution. You’ll work with the Clinical Development Sub-Team, providing strategic and hands-on leadership to ensure the CKD Phase 2 study succeeds. This role offers ownership of the clinical study, engagement with key opinion leaders, and meaningful contributions to Clinical Operations. If you thrive in a collaborative, hands-on environment and are motivated by advancing innovative medicines to patients, this role may be a fit.

Responsibilities

• Clinical Trial Execution & Leadership
  • Lead or oversee a Phase 2 CKD clinical trial, aligning study execution with the broader clinical development plan from design and protocol development to enrollment completion, data analysis, database lock, and final CSR.
  • Develop study enrollment forecasting and site engagement strategies to drive enrollment.
  • Partner with Clinical Science to engage therapeutic area KOLs and plan clinical advisory committee meetings and patient advocacy engagements.
  • Participate on the Clinical Development Sub-Team (CDST) and contribute to clinical development strategy.
• Vendor, CRO & Site Management
  • Lead and facilitate engagement with clinical trial vendors, including budget and contract negotiations.
  • Oversee CROs, vendors, and study sites, ensuring alignment with strategic goals.
  • Develop KPIs in collaboration with CROs to guide oversight and establish governance structures with leadership.
• Budget & Financial Oversight
  • Provide financial oversight across multiple clinical studies, ensuring budget efficiency and alignment with corporate goals.
• Data Quality, Compliance & Regulatory Readiness
  • Ensure high-quality clinical trial data and adherence to study protocols, SOPs, ICH GCP guidelines through overall study management and diligent oversight of CROs/Vendors and monitoring at investigative sites.
  • Partner with Quality Assurance on inspection readiness.
• Process Optimization & Technology Implementation
  • Identify and integrate emerging technologies (AI/ML-driven solutions, advanced analytics) to improve trial planning and execution.
  • Develop best practices and scalable processes within Clinical Operations.
  • Evaluate off-the-shelf systems and tools (e.g., eTMF, CTMS, RBM) for licensing and implementation at Maze.
• Cross-functional Collaboration
  • Collaborate with cross-functional stakeholders to influence program-wide decisions across clinical development, regulatory, data science, CMC, and supply chain.

Skills

• Strategic thinking and the ability to shape clinical development strategy and influence management at study and program levels.
• Strong communication and influencing skills; ability to articulate decisions and foster open dialogue with internal and external stakeholders.
• Leadership, mentoring, and collaboration across multidisciplinary teams.
• Vendor management, contracting, budgeting, and financial oversight for multiple studies.
• Data quality assurance, regulatory compliance, and readiness for inspections.
• Experience with clinical trial systems and tools (e.g., Medidata RAVE, Veeva, CTMS, eTMF, RBM).
• Adaptability in a fast-paced, startup-like environment.

Education

• Bachelor’s degree in a scientific discipline or health-related field.

Qualifications

• 8–10 years of clinical operations experience, including leadership of Phase II–III trials, with a broader program-wide and strategic focus.
• Experience in common disease and/or rare disease drug development.
• Familiarity with regulatory guidelines and inspections (FDA, EMA, ICH-GCP).
• A proven track record planning, conducting, and managing clinical trials including study maintenance, study close-out, clinical trial databases (e.g., Medidata RAVE, Veeva), and knowledge of clinical trial budgeting.
• Strong knowledge of FDA, EMA, ICH-GCP guidelines and inspection experience (preferred), proficiency with clinical trial databases (e.g., Medidata RAVE, Veeva), and knowledge of clinical trial budgeting.
• Direct experience analyzing, negotiating, and managing clinical trial budgets and vendors and leveraging technology to drive clinical trial efficiency.
• Strong strategic thinking, ability to shape clinical development strategy, and influence management at both study and program levels.
• A startup mindset, willingness to roll up sleeves, and ability to work in a fast-paced, evolving, and collaborative team environment.
• Experience providing program-level leadership, mentoring junior staff, and driving strategic decision-making.
• 1–2 years of people management experience with at least 2–3 direct reports (highly desirable).
• Excellent communication skills and the ability to influence internal and external stakeholders.

Additional Requirements

• Willingness to travel up to 30% to support study needs.