FSP Sr. Clinical Scientist - Immunology
About The Position
Senior Clinical Scientist, FSP – Immunology – Remote US or Canada Position leads Phase 1-3 Clinical Trials and oversees medical monitoring. This is not a laboratory/research scientist role. In this role, the selected candidate will lead/support studies; be accountable for the clinical/scientific execution of the protocol; be the clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites); and act as scientific lead on Clinical Trial Team (CTT). Responsibilities include: Responsible for trial design and endpoint development in collaboration with CD; collaborates with medical writing to develop trial results communication for investigators Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports, monitoring data issues and central lab reports Sets up/supports SAC, DMC, adjudication committee; provides scientific input to SM for data management activities (e.g. EDC, DRP, CRF’s_ Protocols/amendments – collaborates with medical writing, participates in governance committee review; authors protocol clarification letters; reconciles and reviews all protocol deviation classifications and assess and prepares protocol deviation list for the CSR May act as mentor to other Clinical Scientists
Requirements
- Degree in Life Sciences or significant experience in clinical development (>14 years)
- BS/BA with 7+ yrs clinical research experience
- MS/PhD with 5+ years clinical research experience
- Minimum 2 years pharmaceutical and clinical drug development experience in a Clinical Scientist role as a lead required.
- Proven ability to effectively manage multiple complex studies
- Medical monitoring experience required
- TA-specific experience in Immunology
- Excellent Excel and PP skills required
- Excellent written and oral communication skills
Responsibilities
- Responsible for trial design and endpoint development in collaboration with CD
- Collaborates with medical writing to develop trial results communication for investigators
- Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports, monitoring data issues and central lab reports
- Sets up/supports SAC, DMC, adjudication committee
- Provides scientific input to SM for data management activities (e.g. EDC, DRP, CRF’s_
- Protocols/amendments – collaborates with medical writing, participates in governance committee review
- Authors protocol clarification letters
- Reconciles and reviews all protocol deviation classifications and assess and prepares protocol deviation list for the CSR
- May act as mentor to other Clinical Scientists
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
