Senior Director, Medical Monitor, Hematology-Oncology

About the role

The Senior Director, Medical Monitor serves as a senior medical and scientific leader within the Clinical Development organization. In this role, you will guide clinical strategy, lead medical oversight for clinical studies, and partner cross-functionally to ensure the successful execution of Cellectis’ clinical-stage programs.

Responsibilities

• Serve as the primary medical monitor for assigned studies, ensuring patient safety and scientific integrity.
• Provide real-time medical guidance to investigators, internal teams, and regulatory authorities.
• Lead ongoing review of safety data, including AEs/SAEs, emerging trends, and risk assessments.
• Partner closely with Pharmacovigilance to ensure comprehensive safety oversight.
• Contribute to the design and planning of UCART clinical programs with a deep understanding of hemato-onc diseases.
• Collaborate with Translational Science, Regulatory, and Clinical Operations to align clinical strategy across programs.
• Participate in site feasibility, investigator engagement, and recruitment strategies.
• Lead investigator calls and contribute to medical case discussions.
• Develop clinical content for protocol documents, ICFs, training materials, and study governance reviews.
• Represent Cellectis in interactions with FDA, EMA, and global health authorities.
• Contribute to regulatory submissions including IBs, DSURs, PSURs, CSRs, and responses to agency questions.
• Build and maintain relationships with KOLs, cooperative groups, and clinical investigators.
• Lead preparation of internal and external clinical presentations, including for DSMBs, investigator meetings, and conferences.
• Contribute to abstracts, posters, and peer-reviewed manuscripts.
• Ensure clear, accurate, and scientifically rigorous communication across all clinical deliverables.
• Support the evolution of Cellectis’ clinical development processes, tools, and best practices.
• Contribute to portfolio-wide initiatives and organizational growth.

Requirements

• MD or DO required
• Board certification/eligibility in Hematology and/or Oncology strongly preferred
• 10–15+ years in pharma/biotech, academic clinical research, or equivalent environment
• 6+ years as a Medical Monitor in interventional clinical trials
• Proven experience in:
• Safety monitoring and AE/SAE assessment
• Clinical data review
• Regulatory interactions and submissions
• Strong understanding of cGCP and global clinical development processes

Qualifications

• Excellent clinical judgment and decision-making skills
• Strong interpersonal and communication skills, with the ability to influence cross-functional teams
• Demonstrated ability to build strong partnerships with investigators, KOLs, and internal stakeholders
• Outstanding scientific writing and presentation skills
• Comfortable in a fast-paced, innovative biotech environment
• Ability to travel up to 20%

Skills

• Expertise in hematology and oncology
• Experience in clinical data review and safety monitoring
• Strong regulatory submission and interaction experience
• Effective communication and collaboration skills

Benefits

• Competitive compensation range: $240k-275k

Pay

• $240k-275k

Schedule

• Hybrid work arrangement