Senior Clinical Scientist

United States·Brisbane,BrisbaneFull-Timesenior

OtherClinical Scientist

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Key Responsibilities

participate in protocol development, develop study CRFs,

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OtherClinical Scientist

Mammoth Biosciences seeks an experienced Senior Clinical Scientist to advance pre-clinical research into clinical trials. This role encompasses both tactical and strategic responsibilities, including the design and execution of clinical trials, as well as meticulous monitoring of data for accuracy and integrity to ensure regulatory compliance. The incumbent will collaborate closely with the medical monitor, operations team, CRO partner, and study sites to ensure an efficient recruitment and follow-up of subjects in accordance with study protocols. Reporting to the VP, Clinical Development, the Senior Clinical Scientist will be responsible for the compilation and analysis of study data for various internal and external reports, as well as for key meetings.

Trial Design and Execution: participate in protocol development, develop study CRFs, ICFs and databases
Data Analyses and Monitoring: monitor clinical trial data for accuracy and integrity
Compliance: ensure all study activities adhere to regulatory and ethical guidelines
Collaboration: act as a bridge between medical monitor, operations, CRO and study sites to ensure efficient communications, subject recruitment and trial management
Reports: write study reports, plans, and make data presentations for internal and external meetings
Other duties as assigned

Master’s degree/PharmD/PhD in a relevant life science field
Minimum of 5 years experience in the pharmaceutical or biotechnology industry, with at least 2 years experience in clinical science/clinical development
Demonstrated experience in the design, execution, and reporting of global Phase 1-3 clinical trials
Strong proficiency in data analysis, interpretation of clinical trial results, and presenting data
Deep knowledge of Good Clinical Practice (GCP), ICH guidelines, and global regulatory requirements for clinical trials (FDA, EMA, etc.)
Excellent verbal, written, and presentation skills with proven ability to communicate with multiple stakeholders
Ability to travel internationally for site visits as needed

Experience managing or directly overseeing clinical monitoring and data management processes
Prior experience in a clinical scientist role within a high-growth, fast-paced biotechnology environment
Demonstrated success in leading cross-functional teams and managing external partners (CROs)
Strong collaborator with strategic planning and independent problem-solving skills
Experienced in patient safety guidelines
Knowledgeable about clinical trial ethics and regulatory standards
Strong follow-up skills
Ability to manage multiple conflicting priorities