Job description
Principal/Senior Scientist - Preclinical Translational
Position Overview:
As a Principal/Senior Scientist on the Preclinical Translation team, you will play a central role in assessing the safety and efficacy of our groundbreaking treatments. Your expertise will shape the selection and development of clinically relevant disease models through execution of GLP preclinical studies. This role offers a unique opportunity to contribute to cutting-edge cell therapies while thriving in a collaborative and innovative environment.
Key Responsibilities:
Position Overview:
As a Principal/Senior Scientist on the Preclinical Translation team, you will play a central role in assessing the safety and efficacy of our groundbreaking treatments. Your expertise will shape the selection and development of clinically relevant disease models through execution of GLP preclinical studies. This role offers a unique opportunity to contribute to cutting-edge cell therapies while thriving in a collaborative and innovative environment.
Key Responsibilities:
- Lead preclinical studies that provide scientific rationale for advancement to human trials, including safety, efficacy, and mechanisms of action studies using clinically relevant in vitro and in vivo models.
- Collaborate with Process & Analytical Development, Regulatory and Clinical teams to drive lean development from research to clinical stages.
- Identify, select, and manage CROs for the execution of small and large animal GLP safety studies, including protocol drafting and study management.
- Design and execute experiments that deliver quality- and data-driven decisions supporting global regulatory compliance.
- Analyze and interpret complex datasets, generate, and present reports to leadership and cross-functional teams.
- Remain current on emerging technologies, scientific approaches, and regulatory guidance.
- Mentor junior scientists and research associates, actively supporting a collaborative culture of continuous improvement, scientific rigor, respect, and trust.
- Ph.D. in Biological Sciences, Stem Cell Biology, Pharmacy, or a related fields with 5+ years of preclinical development experience.
- Hands-on experience supporting cell therapy development with an associated understanding of regulatory requirements is highly desirable.
- Background in non-clinical study design, model development, and a range of in vivo models, ideally including liver disease models.
- Expertise cultivating and differentiating human pluripotent stem cells.
- Proficient in basic cell characterization techniques, including flow cytometry, ddPCR, qPCR, ELISA.
- Experience in CRO and/or scientific team management is an asset.
- Excellent written and verbal communication and interpersonal skills applied to transferring complex information to diverse audiences.
- Well organized with efficient time management skills including the ability to prioritize effectively.
- Contribute to groundbreaking advancements in the field of biotechnology.
- Opportunity for personal and professional growth in a fast-paced and collaborative environment.