Director Clinical Development - Medical Monitor Trainer Lead

Experience Level = 5-7 Years

• Lead training for scientific directors and medical directors in early- and/or late-phase oncology development on clinical data review and medical monitoring best practices.
• Design and deliver live and/or virtual training sessions ranging from foundational to advanced topics, including:
• Roles and responsibilities of the scientific director, medical director, CRO, and other cross-functional reviewers
• Data review within EDC systems, including query generation, query resolution, and follow-up
• Review of listings, patient profiles, aggregate data, integrated data panels, Spotfire, J-Review, and related platforms
• Data cleaning metrics and identification of trends requiring action
• TLF review and interpretation
• Dose escalation review and data interpretation in early-phase oncology studies
• Develop and/or oversight / review of accurate CRF completion guidelines (CCGs) / medical review guidelines; medical monitoring plans and/or CRO
• Review, interpret, and communicate accumulating safety, tolerability, and efficacy data for assigned molecules and studies.
• Provide medical monitoring oversight for ongoing trials, including identification, assessment, and follow-up of important clinical and safety findings.
• Serve as a key reviewer of serious adverse events, supporting timely assessment, documentation, and escalation as appropriate.
• Review patient narratives for completeness, accuracy, and medical relevance.
• Identify data inconsistencies, trends, or emerging safety signals and communicate findings to study teams and stakeholders.
• Collaborate with clinical scientists, clinicians, biostatisticians, data management, pharmacovigilance, regulatory, and CRO partners to ensure high-quality data review and issue resolution.
• Support study team readiness for internal and external data review meetings, safety review meetings, and dose-escalation discussions.
• Contribute to development of training materials, job aids, and standardized review guidance for medical monitors and scientific directors.
• Mentor team members on effective data review practices, medical judgment, and interpretation of trial data.
• Maintain awareness of protocol-specific risks, stopping rules, escalation criteria, and monitoring plans.
• Ensure timely escalation of clinically significant issues and support decision-making related to participant safety and study conduct.

• Advanced clinical degree preferred; other advanced scientific/medical degrees may be considered depending on scope.
• Experience in clinical development, medical monitoring, oncology trials, or data review in early-phase and/or late-phase settings.
• Strong understanding of clinical trial operations, safety review, adverse event assessment, and data cleaning processes.
• Experience with EDC, listings review, patient profiles, safety dashboards, and clinical review platforms such as Spotfire and J-Review.
• Demonstrated ability to train, mentor, and communicate complex clinical information clearly to scientific audiences.
• Strong collaboration, judgment, and problem-solving skills.
• Familiarity with oncology development, dose escalation, and translational or biomarker-driven studies preferred.
• This role may include cross-functional leadership responsibilities in study team meetings, safety review forums, and governance discussions.
• The individual may support multiple studies simultaneously and may be required to prioritize across programs based on development stage and operational needs.

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 , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually – These all are subject to applicable eligibility).