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Salary: USD 235,000 - 250,000 / annual
Olema Oncology is a clinical-stage biopharmaceutical company developing novel therapies for breast cancer and other oncology indications. The company's lead candidate, palazestrant, is in two pivotal Phase 3 trials with top-line data expected in Q1 2027. A follow-on candidate, OP-3136, is a KAT6 inhibitor in early clinical development.
As Director of Clinical Monitoring Oversight, you will report to the Vice President of Clinical Operations and provide strategic and operational leadership for global clinical monitoring across all of Olema's clinical programs. This is a people-management role overseeing Clinical Monitoring Oversight Leads, regional monitoring teams, and vendor/FSP partners.
Key responsibilities include:
- Provide strategic direction and operational oversight of all global monitoring activities
- Oversee internal clinical monitoring teams and FSP vendors providing Clinical Oversight Monitors and Clinical Research Associates
- Adapt monitoring strategies, organizational structures, and resource allocation to meet evolving clinical development needs
- Manage clinical monitoring resource planning, budgets, and forecasts aligned with study priorities and portfolio needs
- Establish governance frameworks with FSP partners, including performance management and continuous improvement
- Define and implement risk-based and centralized monitoring approaches in collaboration with Clinical Trial Leads, aligned with ICH-GCP and regulatory expectations
- Ensure global harmonization of monitoring processes, training, and documentation across programs and regions
- Develop and monitor KPIs and quality metrics to evaluate site performance and FSP delivery
- Collaborate cross-functionally with Clinical Operations, Data Management, Compliance, Quality, Pharmacovigilance, and Clinical Development
- Contribute to development of Monitoring Plans, Oversight Plans, Risk Management Plans, and audit/inspection responses
- Assess monitoring risks and implement mitigation strategies to maintain inspection readiness
- Lead, manage, and mentor internal monitoring and oversight staff
- Support organizational capability development and succession planning
- Serve as Monitoring Oversight representative on cross-functional governance teams
- Drive innovation and process optimization in monitoring practices, including technology and data analytics
- Establish monitoring oversight reporting processes and communication pathways
- May perform full scope of Clinical Oversight Monitor Lead responsibilities as needed
The role is based in either San Francisco or Cambridge and requires 10-20% travel.
REQUIREMENTS:
Education & Knowledge:
- Bachelor's or Master's degree in a scientific discipline
- Expert knowledge of global clinical monitoring oversight strategies and execution
- Deep understanding of ICH-GCP, global regulatory requirements, and inspection readiness expectations
- Strong knowledge of vendor governance models, KPI frameworks, and quality management systems
- Broad understanding of clinical development and cross-functional clinical operations
Experience:
- 12+ years of clinical operations experience
- Minimum 5 years direct site monitoring experience (preferred)
- Minimum 5 years in a role providing oversight of global monitoring activities and FSP/CRO management (preferred)
- 3+ years of demonstrated direct people management experience, including performance management, coaching, and staff development
- Oncology experience required
- Significant experience leading global monitoring oversight activities across programs
- Experience managing FSP/CRO partnerships, including governance frameworks and performance management
- Proven track record of driving monitoring quality, operational efficiency, and performance improvement initiatives
- Experience leading teams and developing monitoring oversight capabilities
- Experience with monitoring resource planning, vendor budgets, and resource utilization (preferred)
Attributes:
- Strong strategic thinking and leadership capability
- Excellent communication, influencing, and negotiation skills
- Ability to lead cross-functional initiatives and align stakeholders
- Strong analytical and decision-making ability
- Results-oriented with high accountability
- Ability to drive consistency and quality across complex global programs
