Senior Director, Clinical Research Scientist

Role Summary

Cellectis’ Clinical Sciences (CS) organization is seeking a highly motivated and experienced clinical Research Scientist to support the development and execution of our innovative proprietary UCART allogeneic CART cell therapies programs. The role involves participating in the design and implementation of the development strategy and supporting Clinical Science Physicians with deliverables necessary for planning and execution of their assigned program, along with collaborating with the Clinical Operations Team to develop clinical development processes, templates and potentially training and management of junior clinical research scientists.

Responsibilities

• Supports the clinical development of assigned programs and participates in the design and implementation of the development strategy
• Provide scientific input into design and implementation of clinical trials, their delivery, clinical data review and data cleaning, interpretation of results, and timely reporting 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
• May co-lead study team meetings in partnership with Clinical Operations study lead
• Supports clinical/medical monitoring and documentation; represents the clinical sciences organization on sub-teams or forums, acts as primary point-of-contact for clinical study or program activities, and provides clinical science inputs into study safety reporting
• Engages with external partners and stakeholders (e.g., cooperative groups, KOLs, clinical investigators) and, with Clinical Sciences Physicians, may interact with health authorities
• Provides strategic clinical science support for assigned studies and programs
• Collaborates to develop Protocol and ICF documents/amendments and presents to governance committee and early clinical development team meetings
• May author/review clinical narratives with pharmacovigilance
• Develops Data Review Plan with Data Management and monitors clinical data for trends; ensures CRF design supports data collection per protocol
• Develops or provides input for clinical presentation slides and materials for internal/external meetings and ongoing communications with Clinical Science Physicians
• Contributes to internal documents and presentations including CSRs and regulatory documents; supports external publications
• Participates in enhancements of team processes, coaching of less experienced scientists; may manage direct reports including hiring, training and development
• Participates in competitive intelligence and market assessments as appropriate
• Maintains scientific and clinical knowledge in assigned therapeutic areas

Qualifications

• Advanced degree in Life Sciences (MD, PhD, PharmD, MS, or similar) preferred
• Minimum of 8 years pharmaceutical/biotech industry experience in clinical development in oncology/hematology clinical trials
• Experience in CAR T-cell therapy is preferred
• Experience in data review, data cleaning, managing and interpreting clinical trial results and experience with writing protocols
• Foundational knowledge of FDA and major regulatory requirements and Good Clinical Practice

Skills

• Strong interpersonal, verbal communication and influencing skills; ability to build relationships with internal and external partners
• Outstanding written communication skills
• Strong analytical and presentation skills; ability to summarize and present key considerations and decision points
• Comfortable working in a fast-paced entrepreneurial environment
• Ability to travel up to 20%

Education

• Advanced degree in Life Sciences (MD, PhD, PharmD, MS, RN or similar) preferred

Additional Requirements

• In-office 4 days per week, required
• Sedentary, desk position