Job Description Summary
The Senior Clinical Scientist role is a multifunctional, clinical project position in the therapeutic area. The position holder works closely with the Senior Global Clinical Program Director and Director Clinical Development Scientist performing delegated tasks in support of the clinical development program as dictated by therapeutic area/ project needs. The position holder is responsible for both scientific input to clinical development strategies, acting as the primary liaison between the assigned therapeutic area and key stakeholders to ensure translation of the development plan into operational deliverables. Contribution to the scientific content of clinical program documents is a key deliverable and includes study synopses and protocols, Investigators Brochures, clinical study reports, conference abstracts, internal and external scientific meeting presentations and peer-reviewed publications.
The Senior Clinical Scientist will:
Contribute to the scientific development of individual clinical studies in alignment with the approved clinical development plan, including authoring and reviewing clinical documents (eg., protocols, eCRFs, ICFs, CSRs).
Contribute to the clinical oversight and medical review in collaboration with the Director Clinical Scientist and Senior Program Director during the conduct of the study.
Review clinical data with some assistance and contribute to the development of clinical presentations and integration of analyses into clinical documents.
Assist in analyzing and interpreting data from clinical studies, and writing/editing or reviewing results in study reports, regulatory submissions, abstracts, posters, presentations, peer reviewed manuscripts, and other documents.
Manage the processes required to support external study review committees; e.g independent data monitoring committees, steering committees.
Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables.
Develop and maintain relationships with clinical investigators, medical educators, clinical research organizations (CRO), affiliated hospitals, state and/or government hospitals, and research institutions to initiate and expedite clinical studies.
Ph.D or MS in life sciences with some previous experience in clinical research or BS with at least 3 years of clinical development experience.
The ability to work cross-functionally is essential.
Excellent communication skills, oral and written, are required.
Strong knowledge of clinical research and the drug development process required.
Proven ability to work independently and in a team setting is essential.
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