Senior Director @ Cellectis

Biology & Biotech (2)
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Biology & Biotech (2)

Cellectis’ Clinical Sciences (CS) organization is seeking a highly motivated and experienced clinical Research Scientist to support the both the development and execution of our innovative proprietary UCART allogeneic CART cell therapies programs.

Description for External Candidates

Job Description

The Director, Clinical Research Scientist participates in design and implementation of the development strategy and supports the Clinical Science Physicians with various deliverables necessary for effective and efficient planning and execution of their assigned program. Additionally, the successful candidate in this role would also be responsible for working closely with the Clinical Operations Team to support the development of clinical development processes, templates and potentially training and management of junior clinical research scientists.

Job 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 successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA)
The Global Development Scientist Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset or cross-tumor area working groups depending on the level of experience
May co-lead study team meetings in partnership with Clinical Operations study lead
Supports the clinical/medical monitoring and associated documentation; attends and represents the clinical sciences organization on various sub-teams or other appropriate forums, act as primary point-of-contact for clinical study or program for clinical science related activities, and providing clinical science inputs into study safety reporting.
Clinical Scientists are likely to have regular external interactions with a variety of internal and external partners and stakeholders, such as cooperative groups, key opinion leaders (KOLs), clinical investigators, clinicians, scientists as well as multidisciplinary internal groups. They may also, alongside the Clinical Sciences Physician, participate in external interactions with health authorities (HAs)
Provides strategic clinical science support for assigned studies and programs
Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required
May author and/or review clinical narratives in conjunction with pharmacovigilance
in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
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
In concert with Clinical Sciences Physicians provide clinical contributions to internal documents and presentations including clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission); as well as external publications (abstracts, posters, manuscripts)
As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists
Where applicable, may manage one or more direct reports and is, in such instances responsible for hiring, training, developing, and retaining talent on his/her staff.
As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment

Core Competencies

Strong interpersonal, verbal communication and influencing skills: can influence without authority and is willing to cultivate relationships with key partners and stakeholders, both internally and externally
Outstanding written communication skills
Strong analytical and presentation skills: effective at summarizing and presenting the key considerations and decision-points
Comfortable working in fast paced entrepreneurial environment
Ability to travel up to 20%

Education and Experience

Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred)
Minimum of 8 years pharma/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 trials results as well as exposure to writing protocols
Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research

Physical Requirements

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

Salary Range

$190,000-250,000 (final salary is dependent on candidate's experience and credentials)

Senior Director

Clinical Research Scientist

Cellectis

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