Director, Medical Monitor (MD)

Cellectis • Ny, NY

82d • $250,000 - $300,000

About The Position

Cellectis' Clinical Sciences team is seeking a highly motivated and experienced Clinical Sciences and Medical Monitor to support the clinical development and execution of our innovative, proprietary UCART allogeneic CAR-T cell therapies. Reporting to the Chief Medical Officer within the Clinical Development Organization, this role participates in the evaluation, strategic planning, design and execution of the development strategy of Cellectis clinical-stage programs by providing medical, and scientific, expertise and direction. The successful candidate would also be responsible for working closely with the Clinical Operations Team to support and execute clinical trial conduct. This individual may also serve as the lead Clinical Research Scientist on one or more specific studies or programs within the Cellectis portfolio and may serve as Clinical Lead on cross-functional program level teams.

Requirements

• Medical Degree (MD or DO) required.
• Hematology or Oncology experience required.
• Minimum of 10-15 years pharma/biotech industry experience; or relevant equivalent clinical; or relevant laboratory research experience.
• Minimum of 6 years' 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, and data review, and related regulatory interactions/response.
• Knowledge of current Good Clinical Practices (cGCP); comprehensive knowledge of clinical trial design; understanding of the overall global drug development process.
• Knowledge of current external regulatory environment, e.g. FDA, EMA requirements, related to clinical development.

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.
• Conduct ongoing medical/safety data reviews in concert with Clinical Sciences team, and providing 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).
• Interact on a regular basis with key internal and external partners and stakeholders, including; cooperative groups, key opinion leaders (KOLs), clinical investigators, clinicians, scientists as well as 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 adequately supports data collection in alignment with assigned protocols.
• Develops and/or provides input for clinical presentation slides and other materials for internal/external meetings.
• Lead development of clinical contributions to internal documents and presentations for assigned studies.
• Participate in and/or lead the ongoing development and/or enhancement clinical development processes, structures, systems, tools, and other resources.
• Participate in competitive intelligence and/or other market/industry assessment activities and projects.
• Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.

Benefits

• Salary Range: $250k-300k (final salary dependent on experience and capabilities)

What This Job Offers

• Industry: Professional, Scientific, and Technical Services
• Education Level: No Education Listed
• Number of Employees: 101-250 employees