Senior Director, Medical Monitor, Hematology-Oncology
Cellectis
New York, NY
Senior Director, Medical Monitor, Hematology–Oncology
Location: New York, NY (Hybrid)
Department: Clinical Development – Clinical Sciences
Reports to: Chief Medical Officer
About Cellectis
Cellectis 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 Overview
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. 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