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 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 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
The base pay range for this position is expected to be $235,000 - $250,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
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Important Information >>>
We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package , seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Fraud Alert : We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olema.com ; our careers page is olema.com/careers ; our LinkedIn page is linkedin.com/company/olema-oncology . Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.