Provide clinical study management and implementation for Clinical and Translational Pharmacology clinical studies at Theravance Biopharma including but not limited to first in human, proof of mechanism and clinical pharmacology labeling studies in accordance with Good Clinical Practice (GCP) and Theravance Biopharma Standard Operating Procedures.
Duties and Responsibilities
This position will provide leadership and support for clinical phase 1 and clinical pharmacology studies across therapeutic areas including but not limited to respiratory, gastrointestinal, cardiovascular, ocular, central nervous system, and inflammatory diseases.
The duties and responsibilities include but are not limited to the following:
Position requires a minimum of a Bachelor of Science degree and at least 3 years of clinical study management experience, including 2 to 3 years of experience working on phase 1 or clinical pharmacology studies within a pharmaceutical or biotech environment or relevant CRO experience.
High level of understanding of the clinical study implementation process.
Strong understanding of CFR and ICH guidelines.
Excellent oral and written communication skills
Exceptional interpersonal and leadership skills with proven ability to effectively work within a multidisciplinary team.
Willingness to travel up to 30%, as necessary, consistent with study or functional needs.
This position does not have any direct reports at the present time but it is expected that this position will have the capabilities to take on supervisory responsibilities for in-house and or consultant staff.
Regular working condition in office area. Full time schedule is expected.
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