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: Education:
- 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
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
Target Pay Range for US: $135-150K
Physical Demands/Work Environment:Work Environment:
- Work is performed in an office environment with exposure to electrical office equipment.
- Frequent travel to clients/ site locations with occasional travel both domestic and international.
Physical Requirements:
- Ability to sit for extended periods and operate a vehicle safely.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Regular and consistent attendance.
- Varied hours may be required.
