Philips Electronics North America
Job Description In this role, you have the opportunity to As the Director, Clinical Development for Philips Volcano, you will lead the development and deliver evidence generation and dissemination strategies to support full product life cycle management for the peripheral segment global product portfolio. You and your team will interact with Marketing, Regulatory, Quality, other functions, along with clinical and scientific leaders, to provide and collect critical input for evidence dissemination and reporting for regulatory submissions, manuscript preparations, clinical evaluations and other deliverables related to the product lifecycle management. You are responsible for Provide clinical strategies, evidence development plans and study design and protocol development with cross-functional teams including Marketing, Health Economics, Regulatory and R&D. Provide strategies to support data dissemination to meet the needs for market registrations by authorities, reimbursement clinical and product marketing and further device development. Lead a high-performing team to successfully drive these studies in accordance with appropriate quality standards including ICH\/GCP, ISO and applicable FDA\/global regulations along with company compliance requirements. Serve as group leader with new product development and marketing leaders to set priorities in in portfolio. Provide input on strategic decisions and ensure clinical affairs representation in core product development team meetings and activities. Lead clinical scientific discussions with regulatory agencies, investigators and clinical thought leaders. Interact with Marketing, Regulatory, Quality, and other functions to provide and collect critical input for evidence dissemination and reporting for regulatory submissions, clinical evaluations and other deliverables related to the product lifecycle management. Leads and directs clinical affairs activities to ensure completion of all deliverables for product development activities. This includes pre-clinical studies, risk management implementation, new product development processes and design history file development as clinical affairs team members. Oversees design and implementation of studies for product development stage medical devices. Drives setting of team goals and milestones; monitors progress. Represents the study team and\/or department during meetings with senior management, FDA, and other global regulatory authorities, business or functional groups. You are a part of Here at Philips WE ARE Working Together for a Better Tomorrow: Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day. Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what\u2019s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy. Thanks to our employees, we are at the forefront of the Healthcare industry. Healthcare providers, backed by our many market leading solutions, are able to diagnose confidently, improve care, and increase the quality of life for patients across North America each and every day. To succeed in this role, you should have the following skills and experience Education: Requires a minimum of a bachelor's degree in a scientific discipline, advanced or professional degree desirable. Knowledge and Experience: Requires 10 years directly with proven track record related experience in clinical\/scientific experience including leadership or management role within device industry. Requires 5 years' experience in managing a clinical research functional team with proven track record in delivering complex clinical programs on time, within budget, and in compliance. Comprehensive understanding of applicable clinical research regulations in multiple regions. Experience interacting with top-level executives Knowledge and experience with global medical device regulations, writing reports, medical device clinical trial practices, GCPs. In-depth knowledge of medical device development regulatory requirements needed. Demonstrated management and cross-functional collaboration skills. Skills and Abilities: Demonstrated ability to build collaborative relationships with key internal and external stakeholders. Ability to effectively lead, drive talent development, and influence through direct and indirect resources to shape organization globally. Meticulous attention to detail and accuracy required Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships. Demonstrated ability to manage multiple projects, staff and company initiatives effectively. Ability to represent the Company at professional and business functions in a competent manner Develops and implements effective solutions to a variety of problems; ensures solutions are consistent with organizational objectives Desirable Qualifications: Experience with medical devices used in a catheterization lab Practical experience with clinical research studies, in the cardiovascular, peripheral vascular or electrophysiology medical device applications in a sponsor company, or equivalent. Lead and shape change in team settings. Supervisory responsibility: Will supervise exempt and nonexempt employees, with a variety of scientific backgrounds Participates in hiring, goal-setting, performance evaluations, termination, promotion and merit decisions. Travel requirements: Travel 20-30% of the time to various customer and sponsor company locations, both domestically and internationally required In return, we offer you Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech \u2013 focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA). Why should you join Philips? Working at Philips is more than a job. It\u2019s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video. To find out more about what it\u2019s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions. Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status. As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Contact If you forgot your password, you can click the Forgot Password button on the Sign In screen to reset it. In\u00a0case\u00a0of\u00a0technical difficulties, please\u00a0send\u00a0an\u00a0email to\email@example.com. (Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)
Philips Electronics North America
Website : http://www.usa.philips.com
Since the introduction of the first Philips light bulb more than 120 years ago, innovation and a people-centric approach have always been at the core of our company.