Senior Clinical Scientist
The Clinical Scientist will be responsible for the design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct. May lead or support trial level activities for one or more trials with the necessary supervision.
- Collaborate and liaise with external partners (e.g., KOLs).
- Develop protocol and ICF documents / amendments and present these to governance committee and development team meetings as required.
- Conduct literature reviews.
- Submit clinical documents to TMF.
- Develop site and CRA training materials and present these at SIVs and investigator meetings.
- Review clinical narratives.
- Monitor clinical data for specific trends.
- Develop data review plan in collaboration with Data Management.
- Review data listings and tables to support data cleaning efforts.
- With supervision from the Medical Lead, participate in medical monitoring meetings with the CROs.
- Review protocol deviation classifications and coding.
- Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
- Submit clinical contributions to 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.).
- Participate in vendor selection.
- Review site feasibility.
- Review key study documents.
- Develop DSMB/DMC study charters, prepare for and lead meetings for key study committees.
- Provide clinical /scientific advice to the study team and participating clinical sites.
- Review SAP and TLGs.
- Lead and develop clinical portion of advisory boards.
- Author and/or review abstracts, publications.
- Perform other duties as necessary.
- Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
- Ability to understand assigned protocol(s) and their requirements.
- Basic knowledge skills to support program-specific data review and trend identification.
- Intermediate medical writing skills and medical terminology.
- Basic planning/project management skills (develop short range plans that are realistic and effective).
- Detail-oriented with commitment to quality.
- Basic knowledge of disease area, compound, current clinical landscape.
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
- Intermediate critical thinking and problem-solving skills.
- Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism).
- Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools).
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate. Domestic and International travel may be required.
Education & Experience:
Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). Seven years of pharmaceutical or biotech industry experience preferred. Minimum 5 years of experience as a Clinical Scientist, clinical trial science lead or similar role.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.