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Preclinical Principal Scientist - Research & Development

CresilonBrooklyn, New York, United States
Hybrid Full-time $130K/yr - $210K/yr

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Experience Level

Mid to Senior

Qualifications

The ideal candidate will possess a PhD in a relevant scientific discipline, complemented by extensive experience in preclinical research, particularly in medical device testing and regulatory submissions. Strong leadership skills, a proven track record of managing research projects, and the ability to work collaboratively in a dynamic environment are essential. Furthermore, candidates should have demonstrated expertise in regulatory compliance and excellent communication skills to engage with both internal teams and external partners.

About the job

Cresilon® is an innovative biotechnology company located in Brooklyn, New York, dedicated to developing, manufacturing, and marketing advanced hemostatic medical devices through our proprietary hydrogel technology. Our groundbreaking plant-based solutions have transformed the standard of care by effectively stopping traumatic and surgical bleeding within seconds, eliminating the need for prolonged manual pressure. Our product lines cater to diverse applications in veterinary, human trauma, and surgical fields. At Cresilon, our mission is to save lives and improve health outcomes across the globe. Discover more about us at www.cresilon.com.

The Preclinical Principal Scientist will be a pivotal scientific leader and subject matter expert (SME) within Cresilon’s Preclinical Research Operations. This role entails overseeing the design and management of in-vivo studies, including safety and efficacy evaluations, while developing strategies to position our products competitively for regulatory and clinical approval both domestically and internationally. The position is hybrid, involving work at CROs in the NY/NJ area, remote work, and on-site collaboration in Brooklyn, NY.

Key Responsibilities:

  • Lead and manage Cresilon’s Preclinical Research initiatives.
  • Provide scientific expertise and leadership on physical safety and efficacy evaluations throughout all product life cycle stages.
  • Plan, direct, and execute study designs and follow-up to obtain approvals for Class I-III medical devices.
  • Develop and review study protocols and reports, mentoring junior associates in experimental design.
  • Oversee Cresilon's preclinical regulatory strategy and communications.
  • Collaborate with Contract Research Organizations (CROs) to conduct biocompatibility/safety and efficacy/functionality research, including managing contracts and agreements with trial sites.
  • Ensure adherence to regulatory compliance standards, including Quality System Regulations (ISO 13485) and environmental protection regulations, while embodying Cresilon’s core values.
  • Act as a Subject Matter Expert (SME) in shaping the growth strategy for the preclinical research department.

About Cresilon

Cresilon is at the forefront of biotechnological innovation, committed to advancing medical technology through the development of effective hemostatic solutions that save lives. Our research and development efforts are driven by a passion for improving healthcare outcomes for patients and practitioners alike.

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