Director, Medical Monitor (MD)

Role Summary

The Director, Medical Monitor leads clinical science activities to support development and execution of UCART allogeneic CAR-T programs. This role provides medical and scientific direction, acts as primary medical contact for trials, and collaborates with Clinical Operations and cross-functional teams to ensure safety, data integrity, and regulatory alignment. It may serve as the lead Clinical Research Scientist on one or more studies and/or as Clinical Lead on cross-functional program teams. The position reports to the Chief Medical Officer within the Clinical Development Organization.

Responsibilities

• Primary medical / safety contact for assigned clinical trials, ensuring protocol adherence by internal and external investigators and study teams
• Serve as the primary contact for all medical-related inquiries from investigators, regulatory agencies, and internal/external teams, ensuring consistent protocol interpretation and clarification
• Monitor clinical trials to ensure participant safety, data accuracy, and protocol compliance, addressing medical issues as they arise
• Responsible for study-related review, assessment, escalation, documentation, and reporting of identified adverse events (AEs), serious adverse events (SAEs), and other safety-related events
• Supports the clinical development of assigned programs and participates in the design and implementation of the development strategy; provides strategic clinical science support for assigned studies and programs
• Lead conference calls with investigators to discuss inclusion/exclusion criteria and provide support for site selection and patient recruitment
• Support the design and execution of assigned clinical trial and/or program and works closely with clinical operations study lead and cross-functional study team members
• Supports clinical/medical monitoring and associated documentation; represents the clinical sciences organization on sub-teams or forums; acts as primary point-of-contact for clinical study or program activities; conducts ongoing medical/safety data reviews
• May co-lead or lead study team meetings in partnership with Clinical Operations study lead
• Participate in external interactions with health authorities; engage with key internal and external partners and stakeholders
• Collaborate cross-functionally to develop Protocol and ICF documents/amendments and present to governance committees
• In collaboration with Data Management/Programming develop Data Review Plan and monitor data trends; ensure CRF design supports data collection
• Develop/provide input for clinical presentation slides and materials for internal/external meetings and ongoing communications with Clinical Science Physicians
• Lead development of clinical contributions to internal documents and presentations for assigned studies, including CSRs and relevant regulatory documents; contribute to external publications
• Participate in development/enhancement of clinical development processes, tools, and resources; participate in market/industry assessment activities as appropriate
• Maintain scientific and clinical knowledge in the assigned therapeutic areas

Qualifications

• Required: Medical Degree (MD or DO)
• Required: Oncology-related expertise; Oncology experience is required
• Required: 10–15 years of pharma/biotech industry experience or relevant equivalent
• Required: Minimum of 6 years of experience with clinical trials in the role of Medical Monitor
• Preferred: Relevant therapeutic area experience
• Required: Demonstrated experience in clinical trial safety monitoring, adverse event reporting, data review, and related regulatory interactions/response
• Required: Knowledge of current Good Clinical Practices (cGCP); comprehensive knowledge of clinical trial design and the global drug development process
• Required: Knowledge of current external regulatory environment (FDA, EMA) related to clinical development

Skills

• Independent work style with strong medical and clinical judgment
• Strong interpersonal, verbal communication, and influencing skills
• Ability to develop and cultivate relationships with internal and external partners
• Outstanding written communication skills
• Strong analytical and presentation abilities; adept at summarizing key considerations and decision points
• Comfortable in a fast-paced, entrepreneurial biotech environment
• Ability to work independently and in a team

Education

• Medical Degree (MD or DO) required
• Oncology-focused education or specialization strongly preferred

Additional Requirements

• Ability to travel up to 20%