Director, Medical Monitor (MD)

Role Summary

Director, Medical Monitor (MD) for Cellectis’ UCART allogeneic CAR-T programs. Provides medical and scientific direction in the development and execution of clinical-stage programs, supports clinical trial conduct, and may lead cross-functional study teams.

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 and supports 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 additional cross functional study team members within the assigned project to execute activities associated with the conduct of the clinical trials
• Supports the clinical/medical monitoring and associated documentation; attends and represents the clinical sciences organization on various sub-teams or other appropriate forums; act as primary point-of-contact for clinical study or program for clinical science related activities; conduct ongoing medical/safety data reviews in concert with Clinical Sciences team, and provide clinical science inputs into study reporting
• May co-lead or lead study team meetings in partnership with Clinical Operations study lead
• Participate in external interactions with health authorities (HAs) and interact regularly with internal and external partners and stakeholders, including cooperative groups, KOLs, clinical investigators, clinicians, scientists and multidisciplinary internal groups
• Collaborate cross-functionally to develop Protocol and ICF documents/amendments and present these to governance committee and early clinical development team meetings as required
• In collaboration with Data Management/Programming develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design supports data collection aligned with protocols
• Develop 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 clinical portions of Regulatory Documents; contribute to regulatory submissions and external publications
• Participate in ongoing development/enhancement of clinical development processes, structures, systems, tools, and resources
• Participate in competitive intelligence and/or market/industry assessment activities as appropriate
• Maintain scientific and clinical knowledge in the therapeutic/disease areas of assignment

Qualifications

• Medical Degree (MD or DO) required
• Hematology or Oncology expertise; Oncology is required
• Minimum of 10‚Äì15 years pharma/biotech industry experience; or relevant equivalent clinical or laboratory research experience
• Minimum of 6 years‚Äô experience with clinical trials in the role of Medical Monitor
• Relevant therapeutic area experience preferred
• Demonstrated experience in clinical trial safety monitoring, Adverse Event reporting, data review, and related regulatory interactions/response
• Knowledge of current Good Clinical Practices (cGCP) and clinical trial design; understanding of global drug development
• Knowledge of regulatory environments (FDA, EMA) related to clinical development

Core Competencies

• Ability to work independently with sound medical/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 skills
• Comfortable in a fast-paced biotech environment
• Proven ability to work independently and in a team
• Ability to travel up to 20%