Apply on Employer Site

Oruka Therapeutics · 2 days ago

Clinical Scientist, Clinical Development

United States

Full-time

Hybrid

Mid Level

$140K/yr - $155K/yr

3+ years exp

Oruka Therapeutics is developing novel biologics for the treatment of chronic skin diseases. The Clinical Scientist will play a crucial role in executing clinical trials, supporting protocol development, and ensuring data integrity while collaborating with cross-functional teams.

BiotechnologyHealth CareMedical

Responsibilities

Contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods

Monitors the data of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines

Perform data review, reconciliation and standardization to ensure high quality outputs

Reviews clinical data to support in the assessment of the safety and efficacy of the investigational drug

Supports the development of clinical documents required during the clinical development process (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports)

Maintains knowledge of the therapeutic area, disease state, and potential drug effects

Assesses clinical data to help identify and analyze safety concerns and adverse events Stays current with relevant medical literature and clinical trial methodologies

Conducts literature reviews as needed for focused scientific questions or documentation

Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical and project management teams to ensure data integrity during the clinical development process

Qualification

Clinical trial designData analysisRegulatory requirementsAdvanced degree in life sciencesLiterature reviewsCommunication skillsCollaborative environment