Director, Clinical Monitoring Oversight

Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. With our transformation into a fully integrated oncology company well underway, it’s an exciting time to be part of Team Olema. Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials. We expect top-line data from OPERA-01, our ongoing Phase 3 trial of palazestrant as a monotherapy in patients with second- or third-line ER+/HER2- metastatic breast cancer (MBC), in Q1 2027 which, if positive, could lead to our first potential approval and commercial launch in 2028. OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients. Together with its mechanism of action, pharmacokinetic properties, and the potential to demonstrate activity in both ESR1 wild-type and mutant tumors, palazestrant could transform the metastatic breast cancer treatment paradigm and provide access to a $15 billion global market opportunity. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape – particularly in combination with palazestrant. We recently presented encouraging Phase 1 monotherapy data from this program across multiple solid tumor types, are advancing patient enrollment in the ongoing combination arms in MBC, and expect to initiate a Phase 1 study of OP-3136 in combination with Bayer’s darolutamide in metastatic castration-resistant prostate cancer by the end of this year. Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and passionate colleagues dedicated to helping the patients we serve feel better, longer. Team Olema possesses a deep commitment to a shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, the drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. We are a small group of nimble self-starters who bring consistency in our quest for the extraordinary every single day. If you’re ready to be part of a tenacious, courageous, agile, and growing team, join us in making a profound impact, together – for our patients, for your career, and for what’s beyond. About the Role >>> Director, Clinical Monitoring Oversight As the Director, Clinical Monitoring Oversight reporting to the Vice President, Clinical Operations you will provide strategic and operational leadership for global clinical monitoring oversight across Olema’s clinical programs. This role ensures that clinical monitoring, whether by internal teams, through Functional Service Providers (FSPs), or outsourced to Clinical Research Organizations (CROs), is executed with high standards of quality and consistency while maintaining compliance with GCP regulations. The Director oversees Olema’s Clinical Monitoring Oversight Leads, regional monitoring and oversight teams, clinical service provider/FSP provider, and site performance. This role will develop and implement global monitoring oversight strategies and standards for Olema’s clinical monitoring execution, driving operational excellence, data integrity, and inspection readiness across all trials with an emphasis on risk-based, data driven processes. The role will adapt to evolving organizational structures, monitoring delivery models, and clinical development needs as Olema's portfolio and operational requirements change. This role is based out of either our San Francisco or Cambridge office and will require 10-20% travel. Your work will primarily encompass: Provide strategic direction and operational oversight of all global monitoring activities across Olema’s clinical programs Oversee internal clinical monitoring and/or oversight team and FSP vendor responsible for providing Clinical Oversight Monitors (COMs) and/or Clinical Research Associates, ensuring alignment, consistency, and accountability across global regions Adapt clinical monitoring and oversight strategies, organizational structures, resource allocation, and operating models to meet evolving clinical development and business needs Oversee clinical monitoring and/or monitoring oversight resource planning, utilization, and related budgets and forecasts, ensuring alignment with study priorities, risk, workload, and portfolio needs Establish and maintain effective governance with the FSP partner, including performance management, risk mitigation, and continuous improvement in monitoring quality and efficiency In collaboration with assigned Clinical Trial Leads, define and implement Olema’s clinical monitoring and oversight strategy, including risk-based and centralized monitoring approaches in alignment with ICH-GCP and regulatory expectations Ensure global harmonization of clinical monitoring and oversight 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 Compliance, Clinical Quality, Pharmacovigilance, Clinical Science, 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 and oversight staff, fostering collaboration, accountability, and continuous improvement Support organizational capability development, succession planning, and evolving staffing needs to ensure effective monitoring and oversight as the clinical portfolio changes 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 Establish and implement monitoring oversight reporting processes, tools, and communication pathways to ensure COMLs provide timely, consistent, and actionable updates to Clinical Trial Leads (CTLs), enabling effective collaboration, risk escalation, and CTL accountability for monitoring quality and performance within their assigned trials May perform the full scope of Clinical Oversight Monitor Lead (COML) responsibilities, including direct oversight of assigned COMs, sites and CRAs, as needed based on study requirements, resource availability, and/or organizational priorities Ideal Candidate Profile >>> A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. Knowledge: Bachelors/Masters 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 sy #J-18808-Ljbffr OpenKrill