Job Description
Job Description Cellectis' Clinical Sciences team is seeking a highly motivated and experienced Clinical Sciences and Medical Monitor to support the clinical development and execution of our innovative, proprietary UCART allogeneic CAR-T cell therapies.
Reporting to the Chief Medical Officer within the Clinical Development Organization, this role participates in the evaluation, strategic planning, design and execution of the development strategy of Cellectis clinical-stage programs by providing medical, and scientific, expertise and direction. The successful candidate would also be responsible for working closely with the Clinical Operations Team to support and execute clinical trial conduct. This individual 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.
Responsibilities include but are not limited to the following: - Primary medical / safety contact for assigned clinical trials, ensuring protocol adherence by internal and external investigators and study teams
- Serve as the primary contact for all medical-related inquiries from investigators, regulatory agencies, and internal/external teams, ensuring consistent protocol interpretation and clarification
- Monitor clinical trials to ensure participant safety, data accuracy, and protocol compliance, addressing medical issues as they arise
- Responsible for study-related review, assessment, escalation, documentation, and reporting of identified adverse events (AEs), serious adverse events (SAEs), and other safety-related events.
- 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.
- Lead conference calls with investigators to discuss inclusion/exclusion criteria and provide support for site selection and patient recruitment
- 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.
- 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 team, and providing clinical science inputs into study reporting.
- May co-lead or lead study team meetings in partnership with Clinical Operations study lead
- Participate in external interactions with health authorities (HAs).Interact on a regular basis with key internal and external partners and stakeholders, including; cooperative groups, key opinion leaders (KOLs), clinical investigators, clinicians, scientists as well as multidisciplinary internal groups..
- Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.
- In collaboration with Data Management/Programming develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with assigned protocols.
- 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.
- Lead development of clinical contributions to internal documents and presentations for assigned studies; 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 - Medical Degree (MD or DO) required.
- Hematology or Oncology
- Oncology is required
- 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, in the role of Medical Monitor
- Relevant therapeutic area experience preferred
- Demonstrated experience in clinical trial safety monitoring, Adverse Event reporting, and data review, and related regulatory interactions/response.
- Knowledge of current Good Clinical Practices (cGCP); comprehensive knowledge of clinical trial design; understanding of the overall global drug development process.
- Knowledge of current external regulatory environment, e.g. FDA, EMA requirements, related to clinical development
Core Competencies - Demonstrated ability to work independently and the exercise of good medical, clinical judgment in resolving critical problems not always covered by existing standards, policies and procedures.
- Strong interpersonal, verbal communication and influencing skills.
- Demonstrated ability to develop and cultivate relationships with key internal, and external, partners and stakeholders.
- 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%
Salary Range: $250k-300k (final salary dependent on experience and capabilities) Cellectis
Job Tags
Flexible hours,