Olema Oncology
Role Overview
Director, Clinical Monitoring Oversight
Reporting to the Senior Director, Clinical Operations, you will provide strategic and operational leadership for global clinical site monitoring activities across Olema’s clinical programs. You will ensure that monitoring—by internal teams, Functional Service Providers (FSPs), and outsourced Clinical Research Organizations (CROs)—is executed to high GCP standards while maintaining compliance. Your focus will be on driving operational excellence, data integrity, and inspection readiness through risk‑based, data‑driven monitoring processes worldwide.
Responsibilities
Provide strategic direction and oversight of all global monitoring activities across Olema’s clinical programs.
Oversee the internal clinical monitoring oversight team and the FSP vendor responsible for Regional Site Monitoring Leads (RSMLs), ensuring alignment, consistency, and accountability across global regions.
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.
Candidate Profile Knowledge
Bachelor’s or Master’s degree in a scientific discipline or a related scientific field is required.
Strong understanding of ICH‑GCP, FDA, EMA, and other global regulatory requirements related to monitoring and clinical trial conduct.
Experience
Minimum 12 years of clinical operations experience in the pharmaceutical or biotech industry.
Minimum 5 years direct site monitoring experience (qualification, initiation, interim, and close‑out visits) with strong understanding of site operations and clinical trial execution.
Minimum 5 years in a role providing global monitoring oversight, including oversight of clinical site monitors, FSP/CRO management and oversight, monitoring quality metrics, KPIs, and governance, and a track record of driving performance improvement and corrective action plans.
Experience overseeing regional monitoring functions and ensuring alignment across geographically distributed teams.
Oncology experience is required.
Attributes
Demonstrated ability to manage FSP or CRO partnerships, including contract governance, KPI development, and issue escalation.
Skilled in risk‑based monitoring methodologies and the use of oversight tools and systems.
Strategic thinker with excellent communication, leadership, and interpersonal skills, with the ability to influence cross‑functionally and externally.
Strong analytical and problem‑solving abilities; adept at managing competing priorities in a fast‑paced environment.
Compensation The base pay range for this position is expected to be $235,000 – $250,000 annually. The total compensation package also includes equity, bonus, and benefits.
Equal Opportunity 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.
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 olev.com; our careers page is olev.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. 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.
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Reporting to the Senior Director, Clinical Operations, you will provide strategic and operational leadership for global clinical site monitoring activities across Olema’s clinical programs. You will ensure that monitoring—by internal teams, Functional Service Providers (FSPs), and outsourced Clinical Research Organizations (CROs)—is executed to high GCP standards while maintaining compliance. Your focus will be on driving operational excellence, data integrity, and inspection readiness through risk‑based, data‑driven monitoring processes worldwide.
Responsibilities
Provide strategic direction and oversight of all global monitoring activities across Olema’s clinical programs.
Oversee the internal clinical monitoring oversight team and the FSP vendor responsible for Regional Site Monitoring Leads (RSMLs), ensuring alignment, consistency, and accountability across global regions.
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.
Candidate Profile Knowledge
Bachelor’s or Master’s degree in a scientific discipline or a related scientific field is required.
Strong understanding of ICH‑GCP, FDA, EMA, and other global regulatory requirements related to monitoring and clinical trial conduct.
Experience
Minimum 12 years of clinical operations experience in the pharmaceutical or biotech industry.
Minimum 5 years direct site monitoring experience (qualification, initiation, interim, and close‑out visits) with strong understanding of site operations and clinical trial execution.
Minimum 5 years in a role providing global monitoring oversight, including oversight of clinical site monitors, FSP/CRO management and oversight, monitoring quality metrics, KPIs, and governance, and a track record of driving performance improvement and corrective action plans.
Experience overseeing regional monitoring functions and ensuring alignment across geographically distributed teams.
Oncology experience is required.
Attributes
Demonstrated ability to manage FSP or CRO partnerships, including contract governance, KPI development, and issue escalation.
Skilled in risk‑based monitoring methodologies and the use of oversight tools and systems.
Strategic thinker with excellent communication, leadership, and interpersonal skills, with the ability to influence cross‑functionally and externally.
Strong analytical and problem‑solving abilities; adept at managing competing priorities in a fast‑paced environment.
Compensation The base pay range for this position is expected to be $235,000 – $250,000 annually. The total compensation package also includes equity, bonus, and benefits.
Equal Opportunity 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.
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 olev.com; our careers page is olev.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. 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.
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