Olema Oncology
Director, Clinical Monitoring Oversight
Olema Oncology, San Francisco, California, United States, 94199
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Director, Clinical Monitoring Oversight
role at
Olema Oncology
Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow‑on product candidate, OP-3136, is a potent KAT6 inhibitor with best‑in‑class potential. Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for
our patients, for your career, for what’s beyond . You can view our latest corporate deck and other presentations here.
About the Role As the 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 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. You will oversee Olema’s Clinical Monitoring Oversight Leads, regional monitoring teams, and site performance. You will develop and implement monitoring oversight strategies and standards for Olema’s clinical monitoring execution worldwide—driving operational excellence, data integrity, and inspection readiness across all trials with an emphasis on risk‑based, data‑driven processes. This role is based out of either our Boston, MA, or San Francisco, CA office and will require about 15% travel.
Responsibilities
Provide strategic direction and operational oversight of all global monitoring activities across Olema’s clinical programs
Oversee internal clinical monitoring oversight team and FSP vendor responsible for providing 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
Ideal 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
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.
Information Allowed Under Equal Opportunity Statement 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 olem.com; our careers page is olem.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.
#J-18808-Ljbffr
Director, Clinical Monitoring Oversight
role at
Olema Oncology
Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow‑on product candidate, OP-3136, is a potent KAT6 inhibitor with best‑in‑class potential. Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for
our patients, for your career, for what’s beyond . You can view our latest corporate deck and other presentations here.
About the Role As the 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 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. You will oversee Olema’s Clinical Monitoring Oversight Leads, regional monitoring teams, and site performance. You will develop and implement monitoring oversight strategies and standards for Olema’s clinical monitoring execution worldwide—driving operational excellence, data integrity, and inspection readiness across all trials with an emphasis on risk‑based, data‑driven processes. This role is based out of either our Boston, MA, or San Francisco, CA office and will require about 15% travel.
Responsibilities
Provide strategic direction and operational oversight of all global monitoring activities across Olema’s clinical programs
Oversee internal clinical monitoring oversight team and FSP vendor responsible for providing 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
Ideal 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
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.
Information Allowed Under Equal Opportunity Statement 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 olem.com; our careers page is olem.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.
#J-18808-Ljbffr