Olema Oncology · 16 hours ago
Director, Clinical Monitoring Oversight
Cambridge, MA
Full-time
Onsite
Director/Executive
$235K/yr - $250K/yr
12+ years expOlema Oncology is dedicated to developing better medicines for breast cancer and beyond. The Director, Clinical Monitoring Oversight will provide strategic and operational leadership for global clinical site monitoring activities, ensuring high standards of quality and compliance with GCP regulations.
BiopharmaBiotechnologyHealth CareMedicalOncologyPharmaceutical
Hiring Manager
Colleen Kabongo SHRM-CP
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
Qualification
Required
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
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
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
Benefits
Equity
Bonus
Benefits
Competitive compensation and benefits package
Company
Olema Oncology
Olema Oncology is a preclinical biotechnology company that develops new drugs for the treatment and prevention of breast cancer.
51-200 employees
H1B Sponsorship
Olema Oncology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (3)
2022 (2)
Funding
Current Stage
Public CompanyTotal Funding
$765.05MKey Investors
Paradigm BioCapital AdvisorsSilicon Valley BankVivo Capital
2025-11-20Post Ipo Equity· $190M
2024-12-02Post Ipo Equity· $250M
2023-09-05Post Ipo Equity· $130M
Leadership Team
Naseem Zojwalla
Chief Medical Officer
Shane Kovacs
Chief Operating and Financial Officer
Recent News
2026-01-13
2025-12-25
Company data provided by crunchbase