Job DescriptionPosition Summary Reporting to the Chief Medical Officer within the Clinical Development Organization, the Director, Clinical Research Scientist participates in evaluation, strategic planning, design and execution of the development strategy of Cellectis clinical-stage programs. The successful candidate would also be responsible for working closely with the Clinical Operations Team to support and execute clinical trial conduct. The Director may also serve as the lead Clinical Research Scientist on one or more specific studies or programs within the Cellectis portfolio and may serve as Clinical Lead on cross-functional program level teams. Primary Responsibilities Responsibilities include, but are not limited to, the following:
- Supports the clinical development of assigned programs and participates and supports the design and implementation of the development strategy; Provides strategic clinical science support for assigned studies and programs.
- Support the design and execution of assigned clinical trial and/or program and works closely with clinical operations study lead and additional cross functional study team members within the assigned project to execute activities associated with the conduct of the clinical trials. May be assigned to one or one or more trials or programs based on 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, conduct ongoing medical/safety data reviews in concert with Clinical Sciences Physician, and providing clinical science inputs into study 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).
- Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.
- Works independently and exercises judgment in resolving critical problems not always covered by existing standards, policies and procedures.
- 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 and/or leads the ongoing development and/or enhancement clinical development processes, structures, systems, tools, and other resources;
- 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
Education and Experience
- Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).
- Minimum of 10 15 years pharma/biotech industry experience; or relevant equivalent clinical; or relevant laboratory research experience
- Minimum of 6 years' experience with clinical trials
- Relevant therapeutic area experience preferred
- Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall global drug development process.
Technical Skills Requirements / 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, and maintains flexible mindset to be successful in a biotech corporate culture
- Proven ability to work independently and in a team setting.
- Ability to travel up to 20%
Physical Requirements
- In office 4 days per week, required
- Sedentary, desk position
Salary Range
- $150,000-175,000 (final salary is dependent on candidate's experience and credentials)