The Senior Clinical Scientist will assist the Chief Medical Officer (and/or designated Development Lead) in all areas of clinical development strategy, study protocol development, ongoing clinical data review, evaluation, documentation and reporting. You will be responsible for all scientific aspects of a study or studies and have a leading role providing clinical science input into regulatory strategy and documents.
KEY RESPONSIBILITIES
- Assist in scientifically sound development of the clinical portions of an integrated development plan
- Conduct preclinical, clinical, and safety data reviews and provide clinical science input into program deliverables
- Represent clinical science at development team meetings, development operations team, or other appropriate forums,
- Collaborate with functional area leads from CMC, Clinical Operations, Safety, Project Management, Bioanalytical, Regulatory, Statistics, and Safety to ensure clinical strategies defined by executive management are being employed
- Prepare and conduct clinical science/program relevant slide presentations required by the project or clinical study (Internal data reviews, training CRO, Kick Off meetings, initiative visit etc) ,
- Serve as a primary point-of-contact for scientific based questions related to your study/program.
- Liaise with appropriate departments within the development team framework and/or external consultants/CRO to define the timing of discussion with regulatory bodies.
- Manage extraction and assimilation of data outputs for team review, CMO review, dose escalation meeting, interim analysis and other forums
- Coordinate and lead relevant interfaces with key consultants and internal team members on regulatory interactions and strategies (e.g., PreIND meetings, IND development plan, protocol design)
- Actively perform research and review of the scientific literature for the purpose of drawing insights which in turn enable strategies for company programs.
- Drive team accountability for completion of company goals related to regulatory milestones and other program milestones.
- Work with statistical functions to ensure accurate completion of the statistical analysis plan and accuracy of table, listing graph outputs (for interim analysis and final TLFs )
- Coordinate, oversee, and lead medical writing activities (e.g. clinical study report process) in accordance with program timeliness