Senior Clinical Scientist

Mammoth Biosciences•Brisbane, CA

About The Position

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. Mammoth Biosciences is a biotechnology company focused on leveraging its proprietary ultracompact CRISPR systems to develop long-term curative therapies, as well as other applications such as decentralized precision diagnostics. Founded by CRISPR pioneer and Nobel laureate Jennifer Doudna and Trevor Martin, Janice Chen, and Lucas Harrington, the companyâ€™s ultracompact proteins are designed to enable in vivo gene editing in difficult to reach tissues utilizing both nuclease applications and new editing modalities beyond double stranded breaks, including base editing, gene writing, and epigenetic editing. The company is building out its pipeline of potential in vivo gene editing therapeutics and capabilities and has partnerships with leading pharmaceutical and biotechnology companies to broaden the reach of its innovative and proprietary technology. Mammothâ€™s deep science and industry experience, along with a robust and differentiated intellectual property portfolio, have enabled the company to further its mission to transform the lives of patients and deliver on the full promise of CRISPR technologies.

Requirements

Masterâ€™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

Nice To Haves

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

Responsibilities

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