Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. The company is seeking a Director, Clinical Monitoring Oversight to provide strategic and operational leadership for global clinical site monitoring activities across Olema's clinical programs.
Requirements
- Provide strategic direction and operational oversight of all global monitoring activities across Olema's clinical programs
- Oversee internal clinical monitoring oversight team and FSP vendor responsible for providing Regional Site Monitoring Leads (RSMLs)
- Establish and maintain effective governance with the FSP partner, including performance management, risk mitigation, and continuous improvement in monitoring quality and efficiency
- Define and implement Olema's monitoring strategy, including risk-based and centralized monitoring approaches in alignment with ICH-GCP and regulatory expectations
- Ensure global harmonization of clinical monitoring processes, training, and documentation across programs and regions
- Develop and monitor key performance indicators (KPIs) and quality metrics to evaluate site performance, FSP delivery, and regional oversight effectiveness
- Collaborate with Clinical Operations, Data Management, Clinical Quality, and Clinical Development to ensure monitoring activities are aligned with program objectives and timelines
- Contribute to the development and review of key operational documents, including Monitoring Plans, Oversight Plans, Risk Management Plans, and audit/inspection responses
- Proactively assess monitoring risks and implement mitigation strategies to maintain inspection readiness
- Lead, manage, and mentor internal monitoring oversight staff, fostering collaboration, accountability, and continuous improvement
- Serve as the Monitoring Oversight representative on cross-functional and governance teams, presenting program updates, risks, and mitigation strategies to senior management
- Drive innovation and process optimization in monitoring oversight practices, including leveraging technology and data analytics to enhance quality and efficiency
Benefits
- Competitive compensation and benefits package
- Equity, bonus, and benefits
- Open, flexible, and friendly work environment
- Opportunity for long-term career development
