Preclinical Principal Scientist

5w1 month ago

Cresilon, Inc.

Brooklyn, US · Full-time · $130,000 – $210,000

About this role

Cresilon is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing proprietary hydrogel technology. The Preclinical Principal Scientist will serve as a key scientific contributor, subject matter expert, and project manager in the execution of preclinical research operations.

This role involves leading in-vivo study design for safety and efficacy evaluations, managing preclinical research and vendor relationships, and developing regulatory strategy. The position is hybrid, with work at CROs in the NY area, from home, and on-site in Brooklyn.

The scientist will work cross-functionally with Regulatory and Quality teams to assess project risks and ensure external facilities meet Cresilon standards. They will also mentor junior associates and oversee modifications to preclinical models to address project needs.

This role offers the opportunity to shape preclinical evidence strategies for domestic and international regulatory acceptance. The scientist will actively interact with the internal and external scientific community to maintain state-of-the-art knowledge and drive growth in the preclinical research department.

Requirements

Advanced degree in life sciences or related field (PhD preferred).
Demonstrated expertise in preclinical study design, including in-vivo safety and efficacy evaluations.
Experience managing Contract Research Organizations (CROs) and negotiating research contracts.
Knowledge of global regulatory requirements (ISO, FDA) and compliance standards (GLP, USDA, AAALAC).
Proven ability to lead cross-functional projects and mentor junior scientific staff.
Strong understanding of medical device classification (Class I-III) and regulatory submission processes.
Experience with hydrogel or hemostatic technology is a plus.

Responsibilities

Lead, staff, and manage Cresilon’s Preclinical Research activities.
Provide preclinical scientific input on evaluation of physical safety and efficacy for technologies and products at all stages of the product life-cycle.
Plan, direct, coordinate, and execute activities related to design, initiation, and follow-up of studies to support approval of Class I-III medical devices.
Develop, write, and/or review study protocols and reports; act as technical mentor for junior associates.
Administer and manage Cresilon's preclinical regulatory strategy and communication.
Work with CROs to execute biocompatibility/safety and efficacy/functionality research, including negotiating and managing contracts.
Ensure company operates within regulatory compliance including Quality System Regulations (ISO 13485), health and safety, and environmental protection regulations.
Oversee design and execution of preclinical functionality and safety in-vivo studies per project timelines; manage budgetary requirements.

Benefits

Hybrid work model with flexibility to work from home, on-site at CRO, and in Brooklyn NY.
Opportunity to work on life-saving plant-based hydrogel medical devices.
Collaborative environment with cross-functional Regulatory and Quality teams.
Access to state-of-the-art preclinical research facilities and external scientific community.