FSP Sr. Clinical Scientist - Immunology

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 scientistrole.***

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 inImmunology

• Excellent Excel and PP skills required

• Excellent written and oral communication skills