Group Director Clinical Affairs (2008614)

Description

Based in Memphis, TN and reporting directly to the Chief Medical Officer, the Group Director of Clinical Affairs is responsible for leading Smith & Nephew’s global clinical study strategy for the Orthopaedic Reconstructive and Trauma business unit.
He/she is working closely with Regulatory Affairs, Research and Innovation and the Hip, Knee, Shoulder/CAS and Trauma Franchises, with strong dotted line responsibilities to the Clinical Affairs teams in Europe and Asiapacific to set the direction in the annual global clinical study strategy meeting.
The Group Director is responsible for preparation, submission and management of studies needed for regulatory submission as well as post-market safety and efficacy and functional studies.
The Group Director is responsible to conduct all clinical study activities in a compliant manner according to Company policies, Advamed Code and Federal law.

Required Skills

LANGUAGE SKILLS:

Ability to read, analyze and interpret regulations, technical standards, guidance documents, test reports, and clinical and medical terminology, and complex documents.
Ability to respond to inquiries and complaints from customers and regulatory agencies.
Ability to write detailed technical submissions, reports, and letters.
Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups or regulatory officials.

MATHEMATICAL SKILLS:

Ability to compute ratio, percent and draw and interpret raw data into graphical representations.
Ability to convert English units into metric units and vice versa.
Ability to comprehend and apply principles of algebra, statistics and calculus and mathematical operations used in various engineering and clinical analyses.

REASONING ABILITY:

Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
Ability to deal with a variety of abstract and concrete variables.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requires sitting and talking or listening more than 2/3 of the time.
Walking or standing less than 1/3 of the time.
Use of hands to use computer or write documents less than 2/3 of the time.
Stooping or reaching less than 1/3 ofthe time.
Ability to use public transportation in the U.S. and internationally to include planes, trains and automobiles.
Searching for, lifting and carrying records weighing up to 25 pounds less than 1/3 of the time.
Ability to have close vision (clear vision at 20 inches or less) to review documents and operate personal computer more than 2/3 of the time.
Required Experience

EDUCATION and/or EXPERIENCE:
Bachelors degree in biology, nursing, chemistry, engineering or equivalent with a minimum of seven (7) years Clinical Studies experience or M.S., Ph.D., or M.D. degree or equivalent with a minimum of five (5) years of direct responsibility for clinical research.
Experience in the medical device industry preferred, but candidates from the pharmaceutical, biologics, and diagnostics industry will be considered.
Extensive knowledge of FDA and international laws, regulations, and guidelines.
Extensive experience with orthopaedic medical devices from both engineering and regulatory applications preferred.
In-depth experience in dealing with FDA and international medical device regulatory agencies.