Senior Director, Clinical Research Scientist

Role Summary

Senior Director, Clinical Research Scientist responsible for designing and implementing development strategy for UCART allogeneic CART cell therapies programs; collaborates with Clinical Science Physicians and Clinical Operations to develop processes, templates, and potentially train and manage 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 trials, 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)
• May 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
• Supports clinical/medical monitoring and associated documentation; acts as primary point-of-contact for clinical study or program for clinical science activities, and provides clinical science inputs into study safety reporting
• Interact with internal and external partners and stakeholders (cooperative groups, KOLs, clinical investigators, clinicians, scientists; may interact with health authorities)
• Provides strategic clinical science support for assigned studies and programs
• Collaborate cross-functionally to develop Protocol and ICF documents/amendments and present to governance committees
• Author/review clinical narratives with pharmacovigilance guidance
• Work with Data Management to develop Data Review Plan and monitor data; ensure CRF design supports data collection per protocol
• Develop input for clinical presentation slides and materials for internal/external meetings and ongoing communications with Clinical Science Physicians
• Contribute to internal documents and presentations including CSRs and clinical portions of regulatory documents (IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses) and contribute to regulatory submissions; participate in external publications
• Participate in enhancements of team processes, structures, systems, tools; coach less experienced Clinical Scientists
• May manage direct reports, including hiring, training, developing, and retaining talent
• Participate in competitive intelligence and market/industry assessments as appropriate
• Maintain scientific and clinical knowledge in assigned therapeutic/disease areas

Qualifications

• Advanced degree in Life Sciences (MD, PhD, PharmD, MS, RN or similar) preferred
• 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, managing and interpreting clinical trial results; exposure to writing protocols
• Solid knowledge of FDA and other major regulatory frameworks and 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 in Life Sciences (MD, PhD, Pharm D, MS, RN or similar) preferred

Additional Requirements

• Ability to travel up to 20%
• In-office 4 days per week, sedentary desk position