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WuXi AppTecUSJob ID 2020-6952OverviewFounded in 2000, the WuXi AppTec is the leading global pharmaceutical, medical device open-access capability and technology platform company with more than 25,000 employees across 25 locations globally. The WuXi platform is enabling more than 3,000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi AppTec's dream that "every drug can be made and every disease can be treated."WuXi Clinical, a wholly owned subsidiary of WuXi AppTec, is a global Contract Research Organization (CRO) providing a comprehensive range of services in clinical development. We provide Phase I to Phase IV clinical development services & BE (Bioequivalence), for products including pharmaceuticals, biologics, and medical devices. With expertise spanning all major therapeutic areas, we deliver the unique blend of an experienced team, combined with the creativity, responsiveness, and customer centric-focus of a highly nimble organization. This forward-thinking approach has allowed us to work on a variety of projects ranging from first-in-human products to marketed drugs and devices.WuXi Oncology (WXO) engages expert consulting, trial design, and turnkey commercial management execution of global Phase I-III trials from Pre-IND through regulatory approval. The company was launched to meet the pressing demand for hard-to-obtain, oncology-focused, commercial development subject matter and expertise needed for Phase I-III trials in China and the United States. Empowering innovators of the most advanced cancer therapeutics and ensuring that even smaller companies receive the best attention and quality of service - meeting the unique challenges of clinical complexity together. Our philosophy and focus is to "Follow the Molecule" from Bench to Bedside, throughout all phases of clinical development, while keeping innovative breakthrough science intrinsically connected to the patient. We believe every cancer can be treated and cured by the development of new medicines.Job Title: Vice President, Global Oncology OperationsJob Summary: The Vice President, Global Oncology Operations is a member of the global executive leadership team, providing strategic direction and leadership to the clinical operations division. This is a remote-based role.Responsibilities
Responsible for the development, training and management of highly performing clinical operations and project management teams
Serves as primary clinical operations client contact in project advisement, proposal development, proposal defense, and contributes to business development efforts
Ensures proper fiscal, regulatory and logistical management of projects to client deliverables and maximizes the opportunity for repeat business
Effectively manages resources, customer relations and daily operations according to WuXi Oncology procedures
Serves as senior team member for development/evaluation of systems and training for operational areas
Evaluates and recommends opportunities for new service offerings in conjunction with business development leadership
Develops and manages clinical operations budget
Contributes to the overall operations and to the achievement of departmental goals
Performs job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Oncology policies and SOP's
Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and other applicable regulations
QualificationsExperience / Education:
15+ years directly related clinical research experience within the CRO/pharma/biotech industry, with 10 years' clinical research project management experience required
8+ years of senior management experience in clinical operations/clinical trial management, leading a medium to large organization and enabling technology solutions
Must demonstrate advanced knowledge of clinical, regulatory, and data aspects of trials including, but not limited to FDA review processes, IND and NDA processes, GCPs, field monitoring, data management, biostatistics, and medical writing
Oncology clinical trials experience required
Master's degree in a life science discipline; PhD preferred.
Knowledge / Skills / Abilities:
Exceptional communication and presentation skills in English required
Strong abilities in influencing senior-level management and key stakeholders
Must show excellent interpersonal skills and exhibit ability to motivate and develop teams
Displays a positive, professional demeanor
Must exhibit excellent technical writing skills, organizational and negotiation skills, with a high level of attention to detail
Ability to effectively resolve issues and implement resolutions to team members\
Expected to have good working knowledge of physician care in hospitals, clinics, or other healthcare settings
Must have advanced knowledge of FDA guidelines and GCPs; excellent project management skills including client management, fiscal management, and quality management
Strong time management skills; and ability to thrive in stressful environment with multiple priorities
Must have solid knowledge of relevant databases and MS Office applications
Must have ability to analyze resource usage with available tools
Approximately 10-15% travel required; primarily domestic/infrequently international, daily/overnight
Must have valid driver's license and be able to rent a car
Physical Requirements:
Must be able to work in an office
Ability to stand or sit for most of the work day
Must be able to perform some activities with repetitive motion, such as keyboarding
Must be able to travel for long distances in various methods of transportation (ie. car, airplane, shuttle bus, )
Must be able to navigate to and from client locations, hotel, and airports with personal luggage and laptop
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. https://www.click2apply.net/2cnj9jhvj7ptrzp8PI122179625
