Steven K Baker

Steven K Baker

Los Angeles United States of America
Martin Smith
+1 267 432 1045 s.baker.ismart.gmail.com

Personal Information

A successful, results orientated manager with experience in many aspects of international business development, product management and clinical & regulatory procedures. Energetic and goal orientated with a passion for bringing innovative technologies to market. PROFESSIONAL ACHIEVEMENTS Worked with SMEs for over 15 years; delivering product development and future commercialization strategies in both professional and OTC markets for new innovative technologies. Specialist light/Laser/LED therapy, class II (special controls) medical devices. Competent and experienced in clinical & regulatory affairs, authored, submitted and executed FDA approvals, Santé Health and Medical CE. Experienced in Shonin and KFDA. Designed, managed and executed phase I-III trials collaborating with Key opinion leaders in fields of Low level light therapy, NMSC, Dermatology, diabetic neuropathy and Herpes. Developed and executed B2B marketing strategies, communications & training programs to maximize sales. Download My Full CV

Employment

2014 - Present

Consultant

i-SMART Consulting US

Offers help to medical device manufacturers looking for assistance in all aspects of product & clinical development, marketing & commercialization.

2009 - 2014

Product Development Manager

Pacer Therapeutics Ltd. UK

SME, medical device company specializing in the development, production and commercialization of both over the counter (OTC) and professional medical light based devices.

2000 - 2009

Business Development Manager

Photo Therapeutics Ltd. UK

Medical Device Company. Manufacturer and global distributor of light emitting diode technology to the medical and aesthetic markets ISO13485: 2003 registered. 8 FDA clearances.

1998 - 2000

Sales Office Manager

Scientific & Chemical Supplies Ltd

Supplier of laboratory chemicals and equipment to industrial and educational markets throughout the UK and Europe.

1993 - 1998

Biomedical Scientist Grade II

Microbiology Dept, City Hospital NHS Trust

Major teaching hospital, Regional Antimicrobial Chemotherapy laboratory.

1988 - 1993

Biomedical Scientist Grade

Microbiology Dept, Selly Oak Hospital NHS Trust

Instrumental in the implementation of a novel fully automated blood culture machine. Wrote in house training manual – adopted by manufacturer.

Education

2011

Master’s degree in Business Administration - Merit “Impact of differing growth strategies in the Pharmaceutical over the Counter (Home-use) device market.” (2011)

2010

Barton Award for Innovation - University of Derby

2007

Statistics for Clinical Trials & Introduction to Randomized Controlled Clinical Trials - University of York

1998

Diploma in Management Studies (MBA Program). Research paper “Fitness to Practice, the Effect of Competency Testing on Biomedical Scientists.”

1992

Fellowship of the Institute of Biomedical Science (Bacteriology option)

1989

Higher National Diploma in Medical Laboratory Sciences with Bacteriology as a specialist option.

3 A Levels (Biology, Chemistry, Food and Nutrition), 9 O levels

Publications:

• Use of Sentinel blood culture system for analysis of specimens from potentially infected prosthetic joints. J Clin Pathol 1994 May; 47(5):475-6

Other Interests

• 2015-. Member of LA Bicycle Coalition, working on education, advocacy and outreach to make LA a safer cycling city. www.LA-BIKE.ORG

• 2013-14. Academic volunteer at Squashsmarts an “out-of-school time” program offering academic and athletic mentoring for 5th-12th graders. Awarded “Volunteer of the year 2013-14”. www.squashsmarts.org

Personal Details

Marital Status: Married

Permanent US resident (Green Card Holder) United Kingdom passport

Driving License: United Kingdom, United States of America – Full - Clean

Download My Full CV