Associate Director Clinical and Preclinical
- JOB TITLE Associate Director Clinical and Preclinical
- FUNCTION Discovery & Pre-Clinical / Clinical Development
Key Responsibilities :
Develop and deliver appropriate global evidence generation strategies (preclinical studies, postmarket studies, investigator initiated, real world evidence) aligned to R&D, Regulatory, Professional Education and Commercial needsEnsure input and strong alignment from key regional leads and other strategically important countries / regions in the development of evidence generation strategiesContribute and support the design of appropriate studies to meet premarket and postmarket needsStrengthen capability in and drive implementation of real-world evidence to deliver cost-effective evidence solutionsIdentify areas of highest impact for the portfolio, create and implement solutions that significantly impact ROI, and communicate impact across the organizationDevelop network with key surgeons in the US and globally to assist in execution of the evidence strategyLead teams to ensure appropriate interpretation and dissemination of all evidence generated, based on evidence dissemination strategy, including study reports, abstracts, manuscripts, etc.Support scientific discussions with regulatory agencies / notified bodies to drive support of the clinical, preclinical, and regulatory strategy, including proposed studies;review process of evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspectionsProvide scientific, technical, and strategic assessment and / or oversight on New Business Development opportunities, and support acquisition of innovative products / devices that will position our company for future growth and successDemonstrate the ability to influence, shape and lead teamsDevelop talent to provide strategic and scientific clinical and preclinical research capability, including responsibility for professional development of direct reportsHave experience in effective management of project budget processesThrough transparent leadership, be a key leader in developing a high-performing team with a global cultureBuild successful relationships internally and develop partnerships with key business partners and customers / investigatorsQUALIFICATIONS
A minimum of a Bachelor s degree in Biological Science or a related area is required. An advanced degree (Master s or PhD) is preferred.Experience and Skills :
Required :
A minimum of 8 years of scientific / technical experience within Clinical and / or Preclinical Research is required.Expertise in clinical and preclinical science and processes along with a broad understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations is required.Proven track record of contributing to clinical and / or preclinical programs on time, within budget and in compliance to SOPs and regulations is required.Preferred :
Experience working in Robotics is strongly preferred.Experience in support of global regulatory submissions for medical devices, biologics, or drugs is preferred.Experience leading a team of scientists to provide strategic and scientific research input across NPD and LCM projects is preferred.Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
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