Cresilon · 1 month ago
Preclinical Principal Scientist, Research & Development
Brooklyn, NY
Full-time
Onsite
Senior Level, Lead/Staff
$130K/yr - $210K/yr
6+ years expCresilon is a Brooklyn-based biotechnology company specializing in hemostatic medical devices. The Preclinical Principal Scientist will lead preclinical research activities, manage vendor relationships, and develop regulatory strategies to support medical device approval.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Lead, staff, and manage Cresilon's Preclinical Research activities
Provide preclinical scientific input and leadership on the 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 the 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 a technical mentor for the development of study experimental designs, protocols, and reports of junior associates
Administrate and manage Cresilon's preclinical regulatory strategy and communication
Work with Contract Research Organizations (CROs) to execute both Biocompatibility / Safety and Efficacy/Functionality research, including negotiating, drafting, and managing research contracts and agreements with pre-clinical trial sites
Ensure that the company operates within the scope of regulatory compliance including Quality System Regulations (ISO 13485), health and safety, environmental protection regulations, and the core values of Cresilon
Be a Subject Matter Expert (SME) for the preclinical research department growth strategy. Actively interact with the internal and external scientific community to maintain state-of-the-art knowledge
Oversee the development of and modifications to preclinical models to address project needs
Oversee the design and execution of preclinical functionality and safety in-vivo studies per project timelines
Surveys the literature to identify and compare competitive product performance and safety risks
Maintain current knowledge in existing regulations, requirements and standards, including but not limited to global regulatory requirements (ISO, FDA, etc) and compliance requirements (GLP, USDA, AAALAC, departmental SOP's, company policies, etc)
Work cross functionally with Regulatory and Quality to assess project risks, product safety and efficacy on NPD projects, including ensuring external facilities meet Cresilon standards for animal use and generating contracts and CRO audits, if necessary
Manage budgetary requirements for all research projects to support efficacy and safety programs
Lead the effort to publish surgical research in peer-reviewed journals
Regularly interface with management to ensure research operations reflect overall corporate vision/strategy
Work with VP of Technology and Director of R&D to ensure long-term vision and goals met to reflect company's charter
Qualification
Required
A Bachelor's in a technical or scientific field is required
Minimum 6+ years' experience in preclinical medical device research is required, preference given to veterinary surgical or human surgical experience
Extensive knowledge of surgery, anatomy, toxicology, and pathology is required
Hands-on surgical experience is required
Strong knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations
Strong communication skills (both written and verbal) is required with the ability to extract key facts from complex information and present concise summaries to management
Demonstrated experience with large animal in vivo surgical research and CRO vendor management is required
Excellent problem solving, conflict resolution, and analytical skills is required
Ability to work effectively both independently and collaboratively in a dynamic team-oriented environment is required
Prior experience and ability to work well with external CROs and collaborators with professionalism and discretion is required
Requires strong leadership and organizational skills including attention to detail and multi-tasking skills
Able to understand and execute to project details but keep overall 'big picture' view of projects, priorities, and strategies is required
Legal authorization to work in the United States
This position is located in Brooklyn, NY and may require up to 30% travel (to monitor and execute out-sourced studies)
Preferred
DVM, PhD or MD in a relevant discipline is preferred
4+ years of people management experience preferred
Experience with planning, directing, and coordinating activities related to studies to support approval of Class I-III medical devices is highly preferred
Experience in a medical device, pharmaceutical, or related setting with a proven record of success in supporting studies for R&D projects is highly preferred
Experience with surgical publication submission strategy is strongly preferred
Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is strongly preferred
Medical Device product development experience, including knowledge of medical device regulations, regulatory/notified body requirements is preferred
Good Laboratory Practices (GLP) experience preferred and working knowledge of Good Manufacturing Practices (GMP)
Experience in developing and commercializing regulated devices under Design Control (21 CFR 820) requirements, GLP/GMP, and ISO regulations is preferred
Hands-on research experience with hemostatic devices and/or coagulation chemistry, strongly preferred
Benefits
Paid Vacation, Sick, & Holidays
Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage
Company Paid Life and Short-Term Disability Coverage
Work/Life Employee Assistance Program
Monthly MetroCard Reimbursement
401(k) & Roth Retirement Savings Plan with company match up to 5%
Company
Cresilon
Cresilon is a medical device company that produces and markets solutions for trauma care.
51-200 employees
H1B Sponsorship
Cresilon has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2021 (2)
Funding
Current Stage
Growth StageTotal Funding
$100.66MKey Investors
Paulson Investment Company
2025-09-09Series Unknown· $23.86M
2022-10-27Series A· $25M
2021-04-08Series A· $14M
Leadership Team
Isaac Miller
EVP & Co-Founder
Scott Levine
Chief Financial Officer
Recent News
Crain's New York Business
2025-09-10
2025-09-06
Company data provided by crunchbase