Job Description Summary This position reports to the VP R&D Surgery and is responsible for the scientific direction and overall management of all preclinical activities for projects including but not limited to innovation, new product development and lifecycle management. Activities include strategy and execution of the preclinical scientific design, coordination, execution and reporting of preclinical biomedical animal and bench research studies to aid in the design and development of medical devices for soft tissue repair/reconstruction, hemostats, sealants and infection prevention product lines. This position works collaboratively with the product platform leaders, marketing, QA, RA, and MA groups to develop and maintain a coordinated plan supportive of divisional products. This position will also require the in-person communication of scientific data to support cross-functional product teams as well as Sales, Marketing, Surgeon Education, or any other business needs as necessary.This role is hybrid at our Warwick, RI site with flexibility to work a few days weekly on site and a few days remotely.Job DescriptionWe are the makers of possibleBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.Essential Duties and Position Responsibilities1. Lead and provide strategic direction for Surgery’s Preclinical Affairs efforts, including the scientific design, coordination, execution and reporting of biomedical animal research studies to aid in the design and development of medical devices for soft tissue repair/reconstruction, hemostat products and sealants.2. Manage, coach and develop Preclinical Affairs team members.3. Cross-disciplinary preclinical study strategic guidance for the platform teams to support concept selection, development, regulatory approval, and comprehensive marketing objectives.4. Building subject matter expertise in core areas relevant to Preclinical study strategies.5. Overall management of internal pre-clinical communications by leveraging study data and advanced marketing collateral to support marketing efforts at and following product launch.6. Negotiate contracts and budgets with contract research organizations (CRO)7. Manage preclinical budget, timelines, and milestones8. Lead study design and execution for preclinical studies (GLP and non-GLP)9. Ensure compliance to all required standards in study protocols, data analysis, and reports10, Participate and provide support in regulatory strategy meetings; to support regulatory submission preparation, review and approval (510k, IDE, PMA, CE Mark)Qualifications, Knowledge, and Skills Required:Bachelor's degree required; Ph.D. or master’s degree in veterinary/animal science, biology, physiology, or related field preferredMinimum of 10 years of Preclinical study experience in an academic, industrial and/or CRO laboratory setting.Prior experience supervising preclinical teams highly preferredStrong verbal and written communication.Proficiency in working in a matrix organization as well as with external labs.Demonstrated successful track record in project management for new product developmentPrevious experience developing and mentoring technical staff.Strong experience working with external CROs with preclinical study vendor management.Demonstrated track record of presenting complex scientific and medical information to medical professionals and hospital administrations.Demonstrated understanding of anatomy/physiology fundamentals.Demonstrated understanding of surgery/immunology fundamentals.Demonstrated understanding of the biological aspects of wound healing.Demonstrated understanding of analysis/interpretation of medical device histopathology.Demonstrated understanding of statistical analysis and the use of statistical software.Knowledge of Good Laboratory Practices (GLP). Excellent organizational skills.Excellent verbal and written communication skills.SKILLSLeadershipInterpersonal CommunicationCollaborationTeamworkCritical ThinkingData AnalysisProblem SolvingTest Strategy DevelopmentSmall and Large Animal SurgeryResearch ExpertiseFor certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Why Join Us?A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.To learn more about BD visitBecton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.PDNPrimary Work Location USA RI - WarwickAdditional LocationsWork Shift
