Title: Associate Director, Global Clinical Study Strategy & Operations
Job #150000TI , Kimberly-Clark Corp.
Location: Neenah WI just south of Green Bay
Function: Quality Assurance, Regulatory and Compliance
Reports to: VP Global Quality and Regulatory
The incumbent is responsible for establishing standard operating procedures that ensure state-of-the-art clinical expertise, assessments, trials, processes and systems are applied that not only ensure human safety, but also drive product innovation, sustainability and speed-to-market. This role provides supervision to Clinical Research Associates and the Clinical Data and Analysis team and works closely with the Clinical Project Management team who manage the overall BU clinical trial strategy and execution of clinical trials and the Global Clinical Affairs Medical Director who provides human safety and compliance input to internal procedures.
- Leads a team that provides operational and data management support for clinical trials that will support the successful commercialization of new and existing products in the areas where K-C has stated claims
- With input from Quality Control and Clinical PM team and Medical Director, design, update and implement appropriate innovative and best-in-class procedures and SOP’s related to clinical study development and execution
- Participate as needed in the management of relations with professional and governmental organizations globally
- Provide leadership to ensure that Clinical Affairs attracts, develops and retains the best people and fosters an environment that motivates a diverse team to fully use its capabilities in achieving desired business results
- Responsible for the department budget
Interested? You can contact Dorothy.Beach@KCC.com to receive more information on this job. Sending your resume would jump-start our process and allow a discussion between your career goals and what Kimberly-Clark needs.
- Bachelors of Science Degree with 7+ years in the device industry that includes a minimum three years direct clinical research/development engagement
- Experience working in a global or similarly structured organization
- Experience in the development and design of study protocols and all related documentation
- Experience in coaching and mentoring at managerial and/or supervisory level
- Business communication skills (e.g., verbal, written, presentation); both external and internal
- Responsible for providing input and oversight of vendor and contractor selection and management
- A history of success in collaborating with business teams and the functions within those teams including Marketing, Sales, R&E, and Quality
- Experience with the participation in cross-functional teams required
- Advanced Degree (MBA, MS, or PhD).
- Global level clinical trial experience preferred.
- Experience in health care/medical device based business.
- Experience with device (IDE’s and studies that have led to PMA and/or PMA supplement application and/or approvals) clinical studies
Travel: Approximately 25% of time; international travel required.
Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 63 countries. Every day, 1.3 billion people – nearly a quarter of the world’s population – trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With a 135-year history of innovation, we believe in recruiting the best people and putting them in the right jobs so that they can do their best work. If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark!
The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position
Kimberly-Clark is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.