Senior Director, Clinical Research Scientist

Role Summary

Senior Director, Clinical Research Scientist. Responsible for supporting the development and execution of proprietary UCART allogeneic CART cell therapies programs, participating in design and implementation of development strategy, and collaborating with Clinical Operations to develop processes, templates, and training for junior clinical research scientists.

Responsibilities

• Supports the clinical development of assigned programs and participates and supports the design and implementation of the development strategy
• Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting on time, and activities required for worldwide registration of the product (clinical input to NDA/BLA)
• Provide expert input or lead functional process improvement initiatives and contribute to cross-asset or cross-tumor area working groups
• Co-lead study team meetings in partnership with Clinical Operations study lead
• Support clinical/medical monitoring and associated documentation; act as primary point-of-contact for clinical study or program for clinical science related activities; provide clinical science inputs into study safety reporting
• Interacts with internal and external partners (KOLs, investigators, clinicians, scientists) and health authorities as appropriate
• Provide strategic clinical science support for assigned studies and programs
• Collaborate to develop Protocol and ICF documents/amendments and present to governance committees
• May author/review clinical narratives with pharmacovigilance
• Develop Data Review Plan with Data Management and monitor data for trends; ensure CRF design supports data collection per protocol
• Develop input for clinical presentation slides and materials for internal/external meetings; support communications for review/discussion with Clinical Science Physicians
• Contribute to internal documents and presentations including CSRs and clinical portions of regulatory documents; contribute to external publications
• Participate in process improvements and coach/guide less experienced Clinical Scientists
• May manage direct reports and be responsible for hiring, training, and development
• Participate in competitive intelligence and market assessments as appropriate
• Maintain scientific and clinical knowledge in assigned therapeutic areas

Qualifications

• Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar)
• Minimum of 8 years pharma/biotech industry experience in clinical development in oncology/hematology trials
• Experience in CAR T-cell therapy is preferred
• Experience in data review, data cleaning, and interpreting clinical trial results; exposure to writing protocols
• Foundational knowledge of FDA and major international regulations; knowledge of Good Clinical Practice

Skills

• Strong interpersonal, verbal communication and influencing skills
• Outstanding written communication skills
• Strong analytical and presentation skills
• Ability to work in a fast-paced entrepreneurial environment

Education

• Advanced degree as listed in Qualifications

Additional Requirements

• Ability to travel up to 20%
• In-office presence required 4 days per week