Director, Scientific and Clinical Affairs (BB-33342)
Found in: Talent CA
Description:OVERVIEWReporting to the Vice President, Innovation and Technology the Director of Scientific and Clinical Affairs is responsible to liaises with the healthcare and/or scientific communities to support the market introduction of the organization's products by defining and supporting clinical activities to further product application, industry position, and market penetration.This position is responsible to work with industry, customers, and collaborators to address scientific questions related to the company’s current and future products. This position will provide clinical/scientific expertise to Research and Development and Marketing teams while assisting in development of clinical studies and scientific strategies supporting the products post- launch market penetration. This also includes development and implementation of clinical strategies to support the registration and approval of new products as well as provide clinical support for existing products. The Director will provide leadership, training and direction to the R&D staff in order to support studies according to protocol requirements, SOPs, ICH/GCP, and the relevant laws and regulations as well as provide guidance in understanding and analyzing both the protocols and the data coming out of such trials. RESPONSIBILITIESOversee the delivery of clinical programs in support of new and existing products.Creation of strategy and clinical studies to support regulatory approvals and product launches. Provide Sr. Management with updates/status reports on internal and external study execution, program milestones, and achievements Serve as professional liaison to customers, researchers and thought leadersFacilitate collaborative relationships with thought leaders as advisors, consultant, investigators, and business development partners to support the product pipelineProvides oversight of clinical protocol development, timeline and budget development, site assessment and selection, negotiation and management of site budgets, project training, and contingency planning to ensure on-time delivery of the final study reportLiaise with and engage study sites, collaborate as needed on study protocols and monitor product evaluations to completionEnsures studies are completed on time, within budget and in compliance with SOPs, FDA and global regulations, and ICH/GCP guidelinesResponsible for the external vendor selection process, development of RFPs, budget and contract negotiations, and management of the vendor for assigned studies. Generate scientific awareness of products pre- and postlaunchPreparation and writing of grant applications for external fundingPresent at national and international meetings to increase portfolio visibilityContribute to and initiate publications both originating internally and created by external collaboratorsAssess potential safety risks and contribute to risk management assessmentsAssess potential safety and adverse eventsParticipation in both external and internal inspections and audits to provide prompt responses to questions and inquires. QUALIFICATIONSKnowledge of Code of Federal Regulations, Good Clinical Practices, and FDA guidelines pertaining to medical devices and biologics. Knowledge of EU Medical Device and In Vitro Diagnostics Regulations. Outstanding organizational and time-management skills such as prioritizing/organizing to meet deadlines of multiple projects with overlapping deliverables. Excellent oral and written communication skills Advanced PC Skills (Microsoft Word, Excel and Power Point)Ability to travelExperience and knowledge in the fields genomics, oncology, microbiome and infectious diseases Knowledge of molecular biology methods and applicationsStrong scientific writing skillsSkilled in effective presentations of scientific data and materialsAbility to effectively present information and respond to questions Requires the ability to work as a member of a multifunctional team, strong interpersonal communication and organizational skills and planning abilityEDUCATION AND/OR EXPERIENCE PhD of Science level education, preferably in a scientific or medical discipline or relevant job experience.Minimum of 5 to 7 years of experience in the EU/FDA regulated medical device or pharmaceutical industry, for sponsor companies or contract research organizations.Supervisory experienceAt DNA Genotek, we are committed to building and preserving an accessible, welcoming, supportive, fair, and inclusive environment. Accommodations are available to support prospective employees during the recruitment and hiring process. Should you require any accommodations, please advise us in advance so that we can work with you to find a suitable accommodation.
calendar_today6 days ago