Associate Director, Clinical Trial Lead

What You’ll Do
- Develop and oversee implementation of the study-level operational strategy for successful delivery of clinical studies.
- Chair the Study Management Team (SMT) to drive development of scientifically robust, operationally feasible, clear concepts/protocols.
- Oversee delivery of studies by CROs to ensure quality execution aligned with time and budget forecasts.
- Partner with the CRO SMT lead to ensure appropriate risk-mitigation plans and effective issue identification/resolution.
- Establish and drive efficient team operations through communication, goal setting, and oversight of strategy implementation.
- Ensure effective, consistent, efficient, and compliant processes.
- Champion synergies among other studies, programs, and development units to enhance study planning and execution.

Required Skills / Qualifications
- Bachelor’s degree in a scientific discipline.
- 8+ years in clinical operations management overseeing outsourced clinical trials (quality, timeline, budget), preferably with sponsor company and CRO.
- Scientific/clinical expertise; strong project management, risk assessment, contingency planning, and communication skills.
- Extensive knowledge of clinical development across trial phases (I–IV) and cross-functional drug development.
- Expertise in GCP, ICH guidelines, and regulatory requirements.
- Ability to establish operational plans and support CRO execution.
- Effective CRO management; ability to adapt to Global Clinical Operations (GCO) outsourcing model.

Preferred Skills
- Experience operationalizing nephrology clinical studies.
- Advanced degree (Master’s or PhD) in a related field.
- Investigator site and/or monitoring experience.