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Salary: USD 235,000 - 250,000 / annual
Olema Oncology is a clinical-stage biopharmaceutical company developing transformative therapies for breast cancer and beyond. The company's lead candidate, palazestrant, is in two pivotal Phase 3 trials with top-line data expected in Q1 2027, targeting a $15 billion global market opportunity.
As Director of Clinical Monitoring Oversight, you will report to the VP 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 across clinical programs
- Oversee internal clinical monitoring teams and FSP vendors providing Clinical Oversight Monitors and Clinical Research Associates, ensuring alignment and accountability across global regions
- Adapt monitoring strategies, organizational structures, and operating models to meet evolving clinical development needs
- Manage clinical monitoring resource planning, utilization, budgets, and forecasts aligned with study priorities and portfolio needs
- Establish and maintain effective governance with FSP partners, including performance management and continuous improvement
- In collaboration with Clinical Trial Leads, define and implement risk-based and centralized monitoring approaches 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, FSP delivery, and regional oversight effectiveness
- Collaborate cross-functionally with Clinical Operations, Data Management, Clinical Compliance, Quality, Pharmacovigilance, and Clinical Development
- Contribute to development and review 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, fostering collaboration and continuous improvement
- Support organizational capability development and succession planning as the clinical portfolio evolves
- Serve as Monitoring Oversight representative on cross-functional governance teams, presenting updates and risks to senior management
- Drive innovation and process optimization in monitoring oversight, including leveraging technology and data analytics
- Establish monitoring oversight reporting processes and communication pathways to enable effective collaboration and risk escalation
- May perform full scope of Clinical Oversight Monitor Lead responsibilities as needed based on study requirements and resource availability
The role is based in 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
