DIRECTOR, CLINICAL OPERATIONS
Kimberly-Clark - Roswell, GA

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Kimberly-Clark is leading the world in essentials for a better life. Headquartered in Dallas, Texas, with nearly 57,000 employees worldwide and operations in 36 countries, Kimberly-Clark posted sales of $20.8 billion in 2011. Kimberly-Clark’s global brands are sold in more than 175 countries. Every day, 1.3 billion people trust Kimberly-Clark products and the solutions they provide to make their lives better. With well-known family care and personal care brands such as Kleenex, Scott, Andrex, Huggies, Pull-Ups, Kotex, Poise and Depend, we hold the No. 1 or No. 2 share position globally in more than 80 countries.

As a global company, we are committed to cultivating a fair, respectful and engaging work environment that inspires our diverse global team to thrive professionally and contribute to the communities where we operate. We also have a responsibility to attain a deeper understanding of our impact on the world. Addressing Sustainability issues and incorporating solutions through all levels of Kimberly-Clark is a critical component of our business.

Director, Clinical Operations
Roswell, Georgia

Kimberly-Clark
Around the world, medical professionals turn to Kimberly-Clark for a wide portfolio of solutions that improve the health, hygiene and well-being of their patients and staff. As part of their healing mission, caregivers rely on Kimberly-Clark to deliver clinical solutions and educational resources that they can depend on to prevent, diagnose and manage a wide variety of healthcare-associated infections. This more than $1 billion global enterprise of Kimberly-Clark Corporation holds the No. 1 or No. 2 market share position in several categories, including infection control solutions, surgical solutions, pain management and digestive health. And throughout the care continuum, patients and staff alike trust Kimberly-Clark medical supplies and devices, KLEENEX tissues, Kimberly-Clark Professional skin care products and SCOTT towels for day-to-day needs.

Position Purpose

Direct a team to provide services including global business plan development, mergers & acquisitions, Health Care strategy and deployment, and operational excellence (a shared services platform consisting of Sales & Marketing Effectiveness and Business Process & Continuous Improvement)

Impact

Provides supervision to clinical project managers, biostatisticians, data managers, medical writers, medical monitors and CRO’s. Decisions tend to be tactical in nature and impact businesses and functions that utilize support from Clinical Operations.

Job Responsibilities

  • Manages and coordinates resourcing for comprehensive enterprise clinical studies project portfolio
  • Assists in defining standardized clinical strategies and processes for development projects
  • Responsible for the execution of clinical studies that support the successful commercialization of new and existing products
  • Oversees management of multiple, concurrent clinical studies through external clinical research organizations (CROs) and internal Project Managers and Clinical Research Associates (CRAs)
  • Initiates, designs, plans, and manages clinical projects according to applicable regulations, SOPs (standard operating procedures) and internal guidelines for human subject testing within agreed time frames and budgets
  • Identifies, recommends, and implements solutions for current clinical programs that are not meeting objectives
  • Develops and implements a standardized technical and ethical review system for all company sponsored clinical research projects
  • Responsible for the department budget
  • Responsible for clinical study project management across the enterprise, inclusive of:
  • Study protocol
  • Budgets
  • CRO management
  • Monitoring oversight
  • Clinical data management
  • Biostatistics
  • Site qualification, training and monitoring
  • Participate in the preparation of regulatory documents for submission to FDA and other regulatory agencies including agencies including but not limited to 510k submissions
  • Design, update and implement appropriate innovative and best-in-class procedures and SOP’s related to clinical study development and execution
  • Coordinate the writing and publishing of results from clinical trials as needed, through medical writers
  • Provide leadership to ensure that Clinical Operations 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.
Basic Qualifications

  • 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
  • Experience in the coordination, compilation and analysis of outcomes data across all protocols in a given project, and in preparation of clinical summaries for submission to the FDA and other regulatory authorities.
  • Strong experience with device (IDE’s and studies that have led to PMA and/or PMA supplement application and/or approvals) clinical studies
  • 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
  • Experience with the participation in cross-functional teams required
Preferred Qualifications

  • Advanced Degree (MBA, MS, or PhD).
  • Global level clinical trial experience preferred.
Please apply at www.kc-careers.com Req ID: 14952

Kimberly-Clark - 2 years ago - save job - block
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About this company
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Kimberly-Clark engages in worldwide manufacturing and marketing of a wide range of products for personal, business and industrial uses....