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.
- 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
QUALIFICATIONS AND EDUCATION REQUIREMENTS
- Minimum of 6 years clinical science experience in pharma/biotech industry including established track record of success within Phase 1 – III drug development projects
- Proficient in medical writing. You have the capability to extract relevant preclinical/clinical data for summation within clinical study reports, IMPDs, investigational brochures, study protocols, and other submission relevant documents
- Experience in working on a multifunctional clinical development team (or equivalent) and in working in a diverse environment
- Strong team player, assertive, and able to “wear many hats” as required within a small startup environment where delegation is not an option.
- Able to evaluate, interpret & synthesize scientific data, you can verbally present and critically discuss clinical trial data in internal and external meetings
- Strong interpersonal, verbal communication and influencing skills
- Ability to support and/or coordinate interfaces with external Key Opinion Leads, advisory boards, or other outside entities
- Well versed and completely familiar with regulatory requirements pertaining to GCP, GLP and GMP.