- Lead, staff, and manage their Preclinical Research Team
- 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 their 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 their core values.
- Be a Subject Matter Expert (SME) for 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 their 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.
- DVM, PhD or MD in relevant discipline required.
- Minimum 6+ years' experience in preclinical medical device research is required, preference given to veterinary surgical experience.
- 4+ years of people management experience preferred.
- Extensive knowledge of surgery, anatomy, toxicology, and pathology is required.
- 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.
- Strong knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations.
- Experience with surgical publication submission strategy is strongly preferred.
- 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.
- Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is strongly preferred.
- 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.
- 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.
- 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).
- Competitive annual base salary range of $150,000 - $220,000, depending upon job level and qualifications.
- 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
- 401(k) & Roth Retirement Savings Plan with company match up to 5%
- Monthly MetroCard Reimbursement
-
Principal Data Scientist
2 weeks ago
NBCUniversal New York, United States**Company Description** · We create world-class content, which we distribute across our portfolio of film, television, and streaming, and bring to life through our theme parks and consumer experiences. We own and operate leading entertainment and news brands, including NBC, NBC N ...
-
Principal, Data Scientist
2 weeks ago
Walmart Hoboken, United StatesPosition Summary... · What you'll do... · As the **Principal Data Scientist, Marketing Data Science **, you will lead the development of world-class analytics within the Walmart US Marketing team. You and your team are responsible for providing insights about retail and product m ...
-
Principal Data Scientist
3 weeks ago
Warby Parker New York, United StatesWarby Parker is on the lookout for a Principal Data Scientist who will help shape experimentation and personalization strategy. To make this possible, this role will work closely with all departments across the company: Growth, Product, Ecommerce and Retail. As a functional leade ...
-
Principal Applied Scientist
3 weeks ago
ROKT New York, United StatesThis position will be based in Sydney, Australia. Rokt will provide relocation and visa support for successful candidates · About Rokt · Rokt is the global leader in eCommerce technology, helping companies seize the full potential of every transaction moment to grow revenue and ...
-
Principal AI Scientist
4 weeks ago
AXA Group New York, United StatesPrincipal Data ScientistMorristown, NJ I New York, NY I USAAXA XL recognizes digital, data and information assets are critical for the business, both in terms of managing risk and enabling new business opportunities. Data Science and Applied AI assets should not only be high qual ...
-
Principal Data Scientist
3 weeks ago
Zocdoc New York, United States Full time· Our Mission · Healthcare should work for patients, but it doesn't. In their time of need, they call down outdated insurance directories. Then wait on hold. Then wait weeks for the privilege of a visit. Then wait in a room solely designed for waiting. Then wait for a surprise b ...
-
Associate Principal Scientist
2 weeks ago
Integrated Resources, Inc ( IRI ) New Jersey, United StatesTitle: Epidemiologist II · Location: West Point, PA Rahway, NJ (HYBRID) · Duration: 24 months · Shift: 8 AM – 5 PM · Job Description: · Primary activities include but are not limited to: · • Coordinate global COA/PRO strategic plans in support of Early Development Teams (EDTs), ...
-
Principal Data Scientist
3 weeks ago
Walmart New York, United StatesJob DescriptionPosition Summary... · What you'll do... · We are at the forefront of attacking one of the most complex problems of e-commerce. Whenever a user types in a query or browses through product categories on the web site, phone or the iPad, our service goes to work. We ...
-
Principal Data Scientist
1 week ago
UnitedHealth Group New York, United StatesDevelop and implement ML algorithms for trend forecasting, claim denial/appeal likelihood, and ETL processes. Collaborate with IT partners and stay connected with the company's AI/ML strategy. Healthcare industry experience, proficiency in P.. ...
-
Associate Principal Scientist, Biomarker
2 weeks ago
Merck Sharp & Dohme Rahway, United StatesWe are currently seeking an Associate Principal Scientist to provide biomarker project management and operational expertise to support cross-functional clinical teams, ensuring the timely and efficient delivery of the biomarker operational aspects of each study in order to advanc ...
-
Principal R&D Scientist
3 weeks ago
DSJ Global New Jersey, United StatesTitle: Principal R&D Scientist · Location: New Jersey · Industry: Chemical Manufacturing · Summary: · A leading Chemical Manufacturing company is seeking a Principal R&D Scientist to join the team This individual will focus on driving the development of high-performance and innov ...
-
Principal Scientist, Clinical Research
3 weeks ago
Merck Sharp & Dohme Rahway, United StatesOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to exce ...
-
Principal Data Scientist
2 days ago
Walmart Hoboken, United States Full timeLocationHOBOKEN, NJCareer AreaData Analytics and Business IntelligenceJob FunctionData ScienceEmployment TypeRegular/PermanentPosition TypeSalaryRequisitionWD What you'll do at Position Summary .What you'll do .As the Principal Data Scientist, Marketing Data Science, you will lea ...
-
Bristol-Myers Squibb New Brunswick, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
-
Principal Data Scientist, Experimentation
3 days ago
Rokt New York, United StatesJob Description · Job DescriptionWe are Rokt, a hyper-growth ecommerce leader. We enable companies to unlock value by making each transaction relevant at the moment that matters most, when customers are buying. Together, Rokt's AI-based relevance Platform and scaled ecommerce net ...
-
Principal Senior Health Scientist
2 weeks ago
Stantec Inc. New York, United StatesGrounded in scientific and technical excellence, teamwork, collaboration, and high ethical standards, Stantec ChemRisk staff are leaders in their fields and guide our work with rigor, a creative spirit, and a vision for growth and opportunity. Our team uses state-of-the-art techn ...
-
Associate Principal Scientist – Biologics
1 week ago
Merck Sharp & Dohme Rahway, United States**Education Minimum Requirements**: · - A Ph.D. with 4 years of experience, a Master's degree with a minimum of 8 years of experience, or a Bachelor's degree with a minimum of 12 years of experience in analytical chemistry, biochemistry, organic chemistry, engineering or other ph ...
-
Principal Applied Scientist, Sponsored Products
2 weeks ago
Amazon New York, United States· Amazon Advertising is one of Amazon's fastest growing and most profitable businesses, responsible for defining and delivering a collection of advertising products that drive discovery and sales. As a core product offering within our advertising portfolio, Sponsored Products (S ...
-
Merck Sharp & Dohme Rahway, United StatesWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research drivenenterprise dedicated to world-class science can succeed ...
-
MSD Rahway, United StatesWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research driven · enterprise dedicated to world-class science can succ ...
Preclinical Principal Scientist - New York, United States - Barrington James
Description
Description:
The Manager of Preclinical Research will serve as a key scientific contributor, subject matter expert (SME) and Manager in the execution of my clients' Preclinical Research Operations, including but not limited to in-vivo study design (Safety and Efficacy/Functionality evaluations), Preclinical Research Management, Vendor Management, and Preclinical Regulatory Strategy. This will include the development and execution of strategies for preclinical evidence necessary to competitively position a project's product for domestic and international regulatory and clinical acceptance.
Job Responsibilities:
The Manager of Preclinical Research will:
REQUIREMENTS
BENEFITS
