Director Clinical Development - Medical Monitor Tr

Director, Clinical Development III/Medical Monitor Trainer Lead

The Medical Monitor / Medical Monitor Trainer leads the direction, planning, execution, and interpretation of clinical trial data for one or more early-phase clinical development programs, with potential support of late-phase programs as capacity allows. This role provides medical monitoring oversight, supports safety and efficacy data review, and delivers structured training to scientific directors and medical directors in early- and/or late-stage oncology development on clinical data review, medical monitoring techniques, and use of key data review tools and platforms.

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.
Potential Qualifications / Experience
• 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.

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.

Job Requirements
• Medical Monitoring
• Clinical Development
• Oncology
• Clinical Trials
• Safety Review
• EDC
• Spotfire
• J-Review
• Data Review
• Medical Monitoring Training
• Pharmacovigilance
• Adverse Events
• Patient Safety
• Dose Escalation
• Data Cleaning
• TLF
• CRO
• Clinical Operations
• Mentoring
• Cross-Functional Leadership
Reach Out to a Recruiter
• Recruiter
• Email
• Phone
• Siddhi Kadakia