Associate Director of Clinical Operations

Associate Director of Clinical Operations

As an Associate Director of Clinical Operations , you will be at the heart of our chronic kidney disease (CKD) clinical development programs, partnering with cross-functional teams to drive clinical trial execution. You’ll work closely with the Clinical Science Lead to co-lead the, providing both strategic and hands-on leadership to ensure the success of our CKD studies. This is an opportunity to take ownership of clinical programs, engage with key opinion leaders, and meaningfully contribute to our Clinical Operations department. If you enjoy rolling up your sleeves, collaborating across teams, and bringing innovative medicines to patients, this role could be the perfect fit for you.
The Impact You’ll Have

• Clinical Trial Execution & Leadership
• Lead or co-lead one or more mid-to-late-stage chronic kidney disease clinical trials, aligning study execution with broader clinical development plan and objectives from study design and protocol development to completion of key study milestones (FPI, enrollment completion, interim analysis, database lock, and final CSR).
• Drive study feasibility efforts to inform site selection strategy to ensure timely study enrollment and completion; develop study enrollment forecasts.
• Partner with Clinical Science to engage with therapeutic area KOLs as well as plan clinical advisory committee meetings.
• Participate on a Program Core Team focused on product level strategy; may be asked to co-lead the Clinical Development Sub-Team (CDST) and contribute to clinical development strategy.

• Vendor, CRO & Site Management
• Lead and facilitate request for proposals from CROs and clinical trial vendors through final vendor selection as well as budget and contract negotiations
• Oversee CROs, vendors, and study sites, ensuring alignment with strategic goals.
• 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, diligent oversight of CROs/vendors and monitoring activities at investigative sites.
• Partner with Quality Assurance on inspection readiness.
• Process Optimization & Technology Implementation
• Take a leadership role in identifying and integrating emerging technologies (AI/ML-driven solutions, advanced analytics) to improve trial planning and execution.
• Partner with Clinical Operations Team in the development of best practices and scalable processes.
• Partner with Clinical Operations Team and other internal stakeholders to evaluate off the shelf systems and tools (e.g. eTMF, CTMS, RBM, etc.) to license and implement.
• Cross-functional Collaboration
• Work at a higher strategic level, collaborating with cross-functional stakeholders to influence program-wide decisions, including clinical development, regulatory, data science, CMC and supply chain.
  As an Associate Director, we also expect our leaders to demonstrate the following Leadership Competencies:
  
  • Communication and Influence
  • Communicates the reasoning behind decisions to appropriate stakeholders.
  • Promotes open communication with internal and external stakeholders.
  • Fosters healthy and respectful debate.
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  You might be the right fit for this role if you have:
  
  • A Bachelor’s degree in a scientific discipline or health related field with 8–10 years of clinical operations experience, including leadership of Phases I–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 start-up to 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.
  • 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.
  • Are willing to travel up to 30% to support study needs.