New York Based Director, Clinical Research Scientist - Cell Therapy, Oncology, Early Clinical Development
We're partnered with a Biotech company to source a Director, Clinical Research Scientist focused on developing ground breaking new therapies for cancer cells. The company are currently focused on making life changing CAR-T immunotherapies in Oncology, this will be the first of its kind and reflectively they need an outstanding team for this project.
Key Responsibilities:
- 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.
- 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. May be assigned to one or one or more trials or programs based on experience.
- 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. May be assigned to one or one or more trials or programs based on experience.
- Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.
- Develops and/or provides input for clinical presentation slides and other materials for internal/external meetings (e.g., DSMB, EOC, site and CRA training for SIV and investigator meetings) and/or ongoing communications for review/discussion in concert with Clinical Science Physicians.
Requirements:
- PhD
- A minimum of 5-10 years experience in industry/clinical development
- Experience in Oncology/Hematology/Cell Therapy
- Previously worked in large pharmaceutical settings
- Live in New York or have the availability to relocate as this role will be 3/4 days in the office
Experience/Knowledge:
- Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall global drug development process.
- Comfortable working in fast paced entrepreneurial environment, and maintains flexible mindset to be successful in a biotech corporate culture
- Experience and knowledge of CAR-T Cells (preferred)