Director Medical Monitor

Director Medical Monitor

The Director Medical Monitor will provide medical oversight, clinical data review, and interpretation support for early phase and late phase clinical development programs. The role will focus on oncology studies and will support safety, tolerability, efficacy, and clinical data assessment throughout ongoing trials. This position will also lead structured training for scientific directors and medical directors on medical monitoring practices, clinical data review, and applicable review platforms.

The individual will collaborate with clinical development, clinical operations, pharmacovigilance, data management, biostatistics, regulatory, and CRO teams. The role requires strong medical judgment, communication skills, clinical trial knowledge, and the ability to identify and escalate clinically significant findings.

Key Responsibilities:

• Lead training sessions for scientific directors and medical directors covering clinical data review and medical monitoring best practices.
• Deliver foundational and advanced training on EDC review, query generation and resolution, listings, patient profiles, aggregate data, and clinical review platforms.
• Review and interpret accumulating safety, tolerability, and efficacy data for assigned studies and programs.
• Provide medical monitoring oversight and identify, assess, document, and escalate important clinical and safety findings.
• Review serious adverse events and patient narratives for completeness, accuracy, medical relevance, and appropriate follow up.
• Identify data inconsistencies, emerging trends, and potential safety signals and communicate findings to study teams and stakeholders.
• Review data cleaning metrics and support resolution of clinical data issues.
• Review and interpret Tables, Listings, and Figures and support clinical data review activities.
• Support dose escalation review and clinical data interpretation in early phase oncology studies.
• Develop, oversee, or review CRF completion guidelines, medical review guidelines, and medical monitoring plans.
• Collaborate with clinical scientists, clinicians, biostatisticians, data management, pharmacovigilance, regulatory teams, and CRO partners.
• Support study team readiness for safety review meetings, internal data reviews, external data reviews, and dose escalation discussions.
• Develop training materials, job aids, and standardized guidance for medical monitors and scientific directors.
• Mentor team members on clinical data review practices, medical judgment, and interpretation of clinical trial data.
• Maintain awareness of protocol specific risks, stopping rules, escalation criteria, and monitoring plans.

Required Qualifications:

• Five to seven years of experience in clinical development, medical monitoring, clinical trials, or clinical data review.
• Hands on experience with medical monitoring activities and clinical trial data review.
• Strong experience with safety review, adverse event assessment, serious adverse event review, and clinical safety escalation.
• Experience reviewing patient profiles, listings, clinical data, and data cleaning metrics.
• Experience working with EDC systems and clinical trial data review processes.
• Experience collaborating with cross functional clinical development, data management, biostatistics, pharmacovigilance, regulatory, and CRO teams.
• Strong communication, clinical judgment, problem solving, and stakeholder management skills.

Preferred Qualifications:

• Advanced clinical, medical, or scientific degree.
• Experience supporting oncology clinical development programs.
• Experience with early phase oncology studies and dose escalation activities.
• Experience with Spotfire, J Review, safety dashboards, and related clinical review platforms.
• Experience reviewing Tables, Listings, and Figures.
• Experience developing or reviewing CRF completion guidelines, medical review guidelines, and medical monitoring plans.
• Demonstrated experience training or mentoring medical monitors, scientific directors, medical directors, or clinical development professionals.
• Experience with translational medicine or biomarker driven oncology studies.

Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - as applicable.