Director, Medical Affairs

Company: Danaher Corporation
Location: Sunnyvale
Posted on: February 20, 2021

Job Description:

Danaher Corporation Director, Scientific Affairs in Sunnyvale , California Cepheid, an industry leader in molecular diagnostics, is seeking a Director, Scientific Affairs who is recognized external expert in an area of specialty who Liaises with the healthcare and/or scientific communities to support the market introduction/penetration of the organization's products by providing clinical information, regulatory background, recommended usage and other related information and partners with external scientific/clinical organizations/individuals to further product application, industry position, and market penetration. Is a recognized external expert in area of specialty. Includes externally-oriented medical/dental . At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. As a member of our team, you'll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us, every moment of every day, to develop rapid groundbreaking solutions for the world's most complex health challenges. POSITION SUMMARY: This position is responsible to work with physicians, laboratory personnel, and scientific and academic researchers and funding agencies to address scientific questions related infectious disease products and test results. This position also provides clinical/scientific expertise to Research and Development, Marketing, Commercial and Product Development teams while assisting in development of clinical studies and scientific strategies that build data supporting use of assays for pre- and post- launch market penetration. It also focuses on pursuing external funding opportunities to support innovative research projects. ESSENTIAL JOB RESPONSIBILITIES: Identify study sites for early adoption studies where products can be launched. Preparation and writing of grant applications for external funding Serve as professional liaison to Cepheid user community: physicians, laboratory directors and scientists, infection control personnel, and independent investigators Generate scientific awareness of Cepheid products pre- and post-launch Present at national and international meetings to increase portfolio visibility Coordinate meetings and visits with thought leaders for competitive intelligence Leverage thought leader relationships by aligning their expertise with Cepheid needs Facilitate collaborative relationships with thought leaders internally as advisors, consultant, investigators, expert guest speakers and business development partners. Contribute to and initiate publications both originating from Cepheid and created by external collaborators Regularly collect and interpret insights in the medical diagnostics environment and provide feedback regarding competitive intelligence Keep abreast of competitive position for Cepheid products Communicate effectively with the Scientific Advisory Board, Laboratory Focus Groups and Key Opinion Leaders (KOL's) to assist marketing in requirements are for product pipeline Liaise with and engage study sites, collaborate as needed on study protocols and monitor product evaluations to completion Assist with trials management with investigator-initiated studies, including securing research contracts, logistics of study start-up, and updates for ongoing studies Serve as a key internal consultant/team member on product design and development for R&D, Marketing, Clinical Affairs, Regulatory Affairs, Government Affairs, and other teams. Analyze discrepant test result reports and investigate causality Assess potential safety risks for diagnostic tests and contribute to risk management assessments Assess potential safety and adverse events related to Cepheid products Serves as key contact for input and interpretation of issues that impact product performance and reliability with ongoing studies. TRAINING RESPONSIBILITIES: (REQUIRED) Complete all assigned and required training satisfactorily and on time Ensure your associates attend and complete all required trainings satisfactorily and on time MINIMUM REQUIREMENTS: Education and Experience (in years): Doctoral degree in Microbiology or M.D. degree, with postdoctoral medical microbiology fellowship, ABMM diplomate or equivalent; with 5+ years of diagnostic laboratory direction experience. Evidence of recognition, at national or international level, through publications, invited presentations, committee roles Knowledge and skills: Experience and knowledge of infectious disease diagnostic test interpretation and their applications to medical management of patients Knowledge of principles of real time PCR and its applications Strong scientific writing skills Skilled in effective presentations of medical data and materials Ability to effectively present information and respond to questions from employees, managers, executive management, vendors and customers Requires the ability to work as a member of a multifunctional team, strong interpersonal communication and organizational skills and planning ability Ability to read, analyze and, professional journals, technical procedures, or governmental regulations. Physical requirements/abilities: Must be able to lift 25 lbs. Must be able to stand for several hours. Work may involve repetitive arm/wrist motions. Physical travel is required and will be up 30% PREFERRED REQUIREMENTS (optional): 3+ years of successful experience in industry within a diagnostic arena. The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here.

Keywords: Danaher Corporation, Sunnyvale , Director, Medical Affairs, Healthcare , Sunnyvale, California