Director Clinical Development Devices
Round Lake, IL
Req ID 51676BR
Business Title
Director Clinical Development Devices
Business
Medical Products
Sub-Business
Research & Development
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
This section focuses on the main purpose of the job in one to four sentences.
This position is a Clinical Development Director for global product development across multiple therapeutic areas, with a focus on medical devices. This person in this position develops clinical trial protocols, identifies and assists in the recruiting of qualified investigators and institutions, monitors studies to ensure compliance with protocol and integrity of data, analyzes results and prepares the medical section of regulatory submissions, and helps in writing study reports.
This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.
1. Responsible for the design of key clinical studies for medical devices within a therapeutic area
2. Leads the development of protocols from the concept stage to study execution
3. Directs clinical studies globally within a therapeutic area in close collaboration with specific therapeutic area team
4. Leads and contributes to development of Human Factors Studies of devices to assess feasibility in a pre-launch and simulated settings
5. Prepares or supervises preparation of a clinical development strategy/plan for key project with realistic timelines.
6. Serves as member of Product Teams focused on new product development or Life Cycle Management for various device projects
7. Collaborates with Engineering and other technical functions as appropriate to ensure rational and realistic product designs and plans
8. Preparation of the clinical sections of regulatory submissions including 510(k), PMA and CE marking
9. Coordinate and drive clinical research programs with appropriate U.S. and International functions.
10. Supervise conduct of key clinical studies within a therapeutic area. Manage staff to monitor clinical studies for protocol compliance, user interface with product, and accuracy of data.
11. Co-manage the clinical research budget for trials within collaboration with clinical operations
12. Initiating/maintaining/reviewing Standard Operating Procedures for conducting clinical trials in compliance with Good Clinical Practices and company policies and procedures.
13. Work collaboratively within Clinical Operations to oversee external vendors including research organizations, CRO's, and central laboratories.
14. Review and approve all research agreements and confidentiality requirements.
15. Lead, manage, and develop clinical research staff within Clinical Development function
16. Collaborate with team members from Clinical Operations including Health Economic Outcome Research, RA, Quality, and Business to drive clinical research programs.
17. Working collaboratively with therapeutic areas to identify clinical KOLs to serve as advisors. Serve as a clinical liaison between Baxter and clinical thought leaders to advise on the therapeutic opportunity, the clinical development plan and on protocol design.
Job Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
•Expert technical, clinical, and problem solving skills including an understanding of device development and working knowledge of drug clinical requirements, their foundation and submission processes, as well as a demonstrated track record of effective clinical management.
•Must be very well-versed in medical device development and has experience in all phases of global clinical research.
•Must have experience developing and executing successfully on Human Factors Studies for a variety of medical devices across different therapeutic areas
•Experience in working within matrix teams on developing 510(k),CE,or PMA dossier submissions is required
•Working knowledge of health authorities regulations in the US and worldwide is desirable
•Excellent oral and written communication skills.
•This individual should have proven leadership skills and the ability to work in a dynamic, matrixed organization and lead multi-functional teams to achieve clinical programs goals and objectives
•Advanced interpersonal skills and a demonstrated ability to manage conflict situations.
•Established credibility and reputation within the profession and with FDA
•Management experience and a demonstrated record of responsible actions consistent with the values of the business.
Education and/or Experience:
•Minimum 10 years of clinical research experience, including a minimum of 6 years leading clinical programs in medical device companies is required
•MD with specialty training in Internal Medicine is highly desirable
•Physicians with other specialty training or PhD will be considered based on the scope and depth of relevant industry experience
•Demonstrated record of successful leadership of clinical development programs and evidence of assuming increasing responsibilities
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
