Job DescriptionSenior Director, Medical Monitor, Hematology-OncologyLocation: New York, NY (Hybrid)
Department: Clinical Development - Clinical Sciences
Reports to: Chief Medical Officer
About CellectisCellectis is a clinical-stage biotechnology company developing
off-the-shelf UCART® allogeneic CAR-T therapies to create a future where gene-edited cell therapies are accessible to all patients who need them. Driven by innovation, scientific rigor, and a commitment to patients, we are advancing a pipeline designed to transform the treatment landscape across hematologic malignancies.
We are seeking a
Senior Director, Medical Monitor with deep Hematology/Oncology expertise to join our Clinical Sciences team and help shape the next generation of UCART therapies.
Role OverviewThe 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. You will be a key contributor to trial design, safety evaluation, regulatory interactions, and data interpretation across the UCART portfolio.
Key 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 heme-onc diseases.
- Support indication prioritization, competitive landscape assessments, and long-range development planning.
- Collaborate with Translational Science, Regulatory, and Clinical Operations to align clinical strategy across programs.
- Provide senior clinical leadership from trial startup through closeout.
- 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.
Education and Experience- 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.
Core Competencies- 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%.
Compensation Range: $240k-275k
