宜昌招聘

POSITION RESPONSIBILITIES:

• Provide strategic directions required for the successful planning and execution of clinical work within various R&D projects in China Market.
• Applies strong influencing skills during product development, registration and commercialization phases to ensure shorter product development process and faster time to market.
• Actively develops and maintains strong relationships with Key Opinion Leaders.
• Collects and represents customer feedback, provides clinical input to facilitate usability testing as applicable to support new product development. Organizes and manages Advisory Board meetings to evaluate new product concepts, consolidates inputs from KOLs, determines key clinical requirements based on collected feedback.
• Develops clinical protocols and associated deliverables to evaluate safety and clinical performance of select products prior to product release or following registration to promote physician adoption in accordance with GCP, applicable regulations and SOPs. Identifies and manages Contract Research Organizations (CROs) and other contractors, as applicable, to support clinical department functions as necessary.
• Identify clinical sites in China and/or other countries, to conduct and observe related medical literature review, animal testing, operation of equipment at customer/clinical sites, and responsible for the accuracy, completeness and regulatory compliance of all clinical study results for their assigned programs.
• Manage clinical study personnel focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies. Interprets and executes on policies and procedures appropriate to clinical programs under his/her management. Recommends modifications to policies and procedures to larger clinical organization as necessary.
• Provide leadership to local and global R&D and clinical/Medical Affairs teams as it related to study strategy, projects, individual tasks and overall study operations. Represent clinical function with internal partners and external customers.
• Proactively engages senior leadership in program risk discussions and provides well thought out solutions to issues.
• Assist in the development of curriculum and train study personnel, including internal staff and external study sites (e.g. Principal Investigators, Study Site Support Staff, etc.).
• Provide significant input and oversight to clinical program budgets and ensures projects/programs are completed on schedule and within budget. Continually assess best practices and implement continuous improvement across studies as well as provide input to global department program execution. Ensures appropriate resources are maintained to effectively conduct clinical programs.
• Applies advanced understanding of regulatory and international standards (FDA, CE, CFDA, etc.) under which clinical studies of medical devices are conducted.

BASIC QUALIFICATIONS:

• Bachelor’s Degree.
• 8+ years’ experience managing clinical research studies. (Master’s degree will substitute for 1 year experience; Ph.D. will substitute for 2 years’ experience).
• Working experience in top medical device company and/or clinical research institution where the candidate has experience managing industry-sponsored clinical trials.
• Experience providing work direction to staff and accomplishing study execution through others.

DESIRED/PREFERRED QUALIFICATIONS:

• Advanced degree (e.g., MS, MA, MPH, PharmD, PhD, DVM, MD) in related medical/scientific field (e.g., clinical medicine, biological science, biomedical engineering, etc.).
• Clinical experience in nephology and/or dialysis.
• Experience managing clinical trials from start to finish (medical device and/or pharmaceutical).
• Scientifically/technically adept (knowledge of product, clinical therapy, trial design, Good Clinical Practices, and global clinical regulations, including CFDA, FDA and ISO regulations, ICH guidelines, for devices, biologics, and/or pharmaceuticals.
• Experience of closely working with R&D team on product development throughout commercialization.
• Prior people management experience; exceptional project management capabilities.
• Strategic thinker, strong analytical, problem solving and negotiation skills.
• Demonstrate excellence in customer interaction and relationship building; skilled in actively maintaining medical advisory board and KOL network across China and other EM or worldwide regions; ability to get new product concepts endorsed by advisory board and key KOLs.
• Ability to work with various interfaces both internal and external; able to work in a cross functional and geography team environment; excellent communication and interpersonal skills, negotiating, managing change, goal setting, planning, organizing and inspiring teamwork; ability to address difficult situations.
• Self-starter and capable of working with minimal supervision; ability to multi-task across multiple projects.
• Good oral and written communication skills; fluency in English and Mandarin required.
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PHYSICAL JOB REQUIREMENTS:

• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
• Able to travel domestically and internationally.

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.