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Job Details

Dir Clinical Affairs - Wound Healing

Company name
Medline Industries, Inc.

Location
Northfield, IL, United States

Employment Type
Full-Time

Industry
Manager, Executive, Chemistry

Posted on
Jan 07,2019

Valid Through
Apr 22,2019

Profile

Dir Clinical Affairs - Wound Healing','RES01003C','US-IL-Northfield','!*!Medline Industries has a Director,

Clinical Affairs-Wound Healing opportunity available based at our

Northfield, IL headquarters.  The Director of Clinical Affairs

will manage a team of clinical study professionals in the development,

coordination, and execution of clinical research and affairs activities,

providing input on commercial and clinical development strategies.  We are

seeking a dynamic, hard-working professional with a solid education and

experience along with a desire to work for a fast-paced, large corporate

organization. In addition to exceptional leadership and analytical skills, you

must have a “roll-up your sleeves” attitude

 

Responsibilities include:

Accountable

for strategic leadership and technical oversight towards successful

execution of division level clinical study initiatives.Responsible

for facilitation of effective internal and external departmental

relationships, efficient group functionality, new process and method

evaluation, and achievement of clinical research department goals.Responsible

for managing the strategy, design, development, and evaluation of the

clinical plans and expediting the implementation of related clinical

trials for the purpose of regulatory filing, obtaining outcomes data, and

marketing efforts.Guide

the selection and management of clinical research organizations used for

the project study trials and coordinate the delivery of clinical trial

supplies.  Work

with members of the division or the project team, identifying issues that

might delay the project and make recommendations to improve timelines for

project completion.Coordinate

closely with cross-functional leaders (medical affairs, divisions,

compliance, regulatory, etc.) to ensure optimal alignment of commercial

goals, site operations, data monitoring and review, and safety

surveillance and reporting.Interact

regularly with senior management and key medical opinion leaders in the

synthesis of clinical development plans and clinical research strategies.Provide

technical direction in CRO, vendor selection/management, budget planning,

contract administration/ management to ensure that timelines and

expectations are met.Accountable

for the development of scientific and clinical marketing materials to

ensure that they are accurate and scientifically sound.

 

Management responsibilities include:  

--Strategic, tactical and operational planning (12 months) for the function

or department;

--Direct budgetary responsibility for one or more departments, functions or

major projects/programs;

--Interpret and execute policies for departments/projects and develops;

--Recommend and implement new policies or modifications to existing policies;

','!*!Requirements include:

Advanced degree (PhD or MD) in a clinical area of focus

strongly preferred. Bachelor’s degree in Chemistry, Biology, Pharmacy,

Nursing, or Life Sciences required. At least 10 years of experience in a clinical trial

role such as project management, site monitoring, or clinical supply. Experience

in wound healing desirable.At least 5 years of managing people; including

coaching, mentoring, and/or training staff. Experience applying knowledge of data management, data

review and analysis, and safety surveillance/reporting.Experience applying knowledge of clinical medical

device standards, FDA Code of Federal Regulations, GCP/ICH guidelines, and

regulatory compliance.Experience demonstrating in-depth domain knowledge of

clinical research operations, clinical research study designs/strategies,

and global business strategies for medical devices associated with wound

healing and care.Experience and skills in influencing, leading and

directing individuals in multiple functional areas.

','Dir Clinical Affairs - Wound Healing

Company info

Medline Industries, Inc.
Website : http://www.medline.com

Company Profile
Medline is the largest privately held manufacturer and distributor of healthcare supplies in the United States, providing more than 350,000 products that serve the entire continuum of care. Our innovative products and programs can be found in most hospitals, extended-care facilities, surgery centers, physician offices, home care dealers, home health agencies and retail outlets.