Cellectis · 5 hours ago
Senior Director, Clinical Research Scientist
New York, United States
Full-time
Onsite
Director/Executive
$190K/yr - $250K/yr
8+ years expCellectis is a biotechnology company focused on developing innovative therapies. They are seeking a Senior Director, Clinical Research Scientist to support the development and execution of their UCART allogeneic CAR T-cell therapies programs.
BiopharmaBiotechnologyHealth CareMedicalOncology
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
Qualification
Required
Minimum of 8 years pharma/biotech industry experience in clinical development in oncology/hematology clinical trials
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
Preferred
Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred)
Experience in CAR T-cell therapy is preferred
Company
Cellectis
Cellectis is a biopharmaceutical company that develops adoptive immunotherapies for cancer.
51-200 employees
H1B Sponsorship
Cellectis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$393.48MKey Investors
European Investment BankAstraZeneca
2024-12-10Post Ipo Debt· $5.27M
2023-11-01Post Ipo Equity· $140M
2023-02-07Post Ipo Equity· $24.35M
Leadership Team
A
Arthur Stril
Chief Financial Officer & Chief Business Officer
Recent News
GlobeNewswire
2026-01-09
2026-01-06
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