Simone Franklin
Fairview Heights
Summary
Dynamic Doctor of Health Science with over 12 years of experience in managing complex global clinical studies and executing comprehensive medical affairs strategies, including publication plans and advisory boards. Expertise in team leadership, budget management, and project oversight, complemented by exceptional communication skills for effectively presenting intricate data to diverse audiences. Proficient in the development processes for IVDs and medical devices, with a proven track record in FDA (510k) submissions and CE markings. Thorough understanding of clinical trial processes, project management methodologies, and regulatory guidelines such as FDA, ISO, ICH, EUMDR, and IVDR, combined with strong strategic thinking and business acumen to drive successful outcomes.
Overview
23
23
years of professional experience
Work History
Director, Clinical Research Scientists
bioMerieux Inc.
Hazelwood, MO
09.2022 - Current
- Lead clinical research strategy, including investigator-initiated and bioMerieux-initiated studies
- Establish and lead the clinical operations strategy, setting Medical Affairs department goals and driving initiatives that support bioMerieux organizational objectives
- Monitor the evolving regulatory environment (ICH-GCP, FDA, IVDR/MDR) and update Medical Affairs practices to ensure alignment with current industry standards
- Lead the evaluation and setting department goals and driving initiatives that support bioMerieux global objectives and a culture of accountability and continuous improvement.
- Promote strong cross-functional collaboration with multiple departments (e.g. business development, clinical affairs, regulatory, engineering, scientific programs) across the organization to develop forward-looking well integrated products
- Represent Medical Affairs in the development of go-to-market strategy for current (and future) product offerings
- Develop and execute complete product lifecycle management strategy: from product rollout (including evaluation sites, limited and full commercial release schedule) to end-of-life strategies, etc.
- Identifies and engages with key opinion leaders, scientific experts, and professional societies to exchange scientific data
- Support publication planning, abstracts, and presentations of clinical data.
Clinical Affairs Manager
Stryker Inc.
Kalamazoo, MI
07.2021 - 08.2022
- Provide guidance, recommendations, and implementation plans for adherence to new clinical regulatory requirements or expectations.
- Establish standard processes to ensure appropriate resolution and management of the responsible task owner
- Chair meetings required to drive clinical strategies
- Manage and provide updates for quality metrics as needed
- Represent clinical processes during internal and external audits.
- Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.
- Recruit, onboard and motivate a high performing team, addressing issues and development as need arises
- Supporting creation of Clinical Investigation Protocols and Management of Clinical Projects Ethical approval process support for clinical and pre-clinical investigations in both Europe and US Data management support.
Clinical Affairs Manager
bioMerieux Inc.
Hazelwood, MO
07.2014 - 07.2021
- Supervise preparation of complex clinical trials, including selecting and qualifying sites, researching and writing trial plans and protocols, setting up, equipping and training sites, as well as negotiating site contracts
- Supervise the conduct and monitoring of clinical trials, coordinating all contact with the sites, problem solving, analyzing data, as well as building and maintaining relationships with investigators and sites
- Review of data with clinical scientists and problem solve when necessary
- Supervise the preparation and assembly of final trial reports and conduct technical meetings to evaluate data
- Supervise the completion of clinical trial summary reports and prepare data for submission to each applicable regulatory agency
- Responsible for the validation of clinical trial software (and other applicable EDC) and product components
- Subject matter expert for clinical trial-related processes and deliverable in audits conducted by FDA/MDSAP and other relevant regulatory agencies
- Provide coaching and mentoring of clinical scientists
- Responsible for the development of training materials for staff
Microbiology Department Manager
Belleville Memorial Hospital
Belleville, IL
01.2012 - 07.2014
- Responsible for supervising bench level microbiologists, as well as the technical operation of the Microbiology department
- Validated and implemented new instrumentation including VITEK 2, BACTEC FX, Cepheid, BD Affirm, and Illumipro Illumigene
- VITEK 2 key operator
- Conducted and participated in CAP inspections
- Participated in Infection Prevention protocols and antimicrobial stewardship to decrease the incidence and prevalence of antimicrobial resistant organisms throughout the hospital
- Implemented new urine collection devices to decrease urine contamination
- Implemented wound collection device to simplify the collection processes for nursing staff
- Streamlined work flow to increase productivity within the Microbiology department
- Wrote departmental procedures for all testing performed
Lead Medical Technologist, Microbiology
VA Medical Center
ST Louis, MO
10.2010 - 01.2012
- Responsible for mentoring and supervising junior medical technologists in all areas of microbiology testing, including identification and antimicrobial susceptibilities using VITEK 2, Etest, Kirby Bauer and other manual identification/susceptibility methods
- Utilized standardized methods such as CLSI to determine antimicrobial breakpoints for MIC reporting
- Experience with the isolation and reporting of antimicrobial resistant bacteria including MRSA, VRE, VISA, ESBL, AmpC and CRE
- Experience with isolating and identifying Mycobacteria and fungi including molds
Medical Technologist, Microbiology
Bonsecours Health Center
Suffolk, VA
08.2007 - 04.2010
- Performed testing in all areas of Microbiology including bacterial identification and more extensive work-up and antimicrobial susceptibilities using VITEK 2
- Utilized standardized methods such as CLSI to determine antimicrobial breakpoints for MIC reporting
Medical Technologist, Microbiology
US Navy
07.2003 - 07.2007
- Performed testing in all areas of Microbiology including bacterial identification and more extensive work-up and antimicrobial susceptibilities
Education
Doctor of Health Science -
AT Still University
Kirkwood, MOMasters - Public Health
Eastern Virginia Medical School
Norfolk, VAMasters - Science
Old Dominion University
Norfolk, VASkills
- Relationship building
- Strategic planning
- Verbal and written communication
- Decision-making
- People management
- Operations management
- Project management
- Strategies and goals
- Contract and vendor management
- Legal and regulatory compliance
- Cross-functional team leadership
Affiliations
ASCP, Medical Technologist
Personal Information
Title: Director, Global Medical Affairs
Timeline
Director, Clinical Research Scientists
bioMerieux Inc.
09.2022 - Current
Clinical Affairs Manager
Stryker Inc.
07.2021 - 08.2022
Clinical Affairs Manager
bioMerieux Inc.
07.2014 - 07.2021
Microbiology Department Manager
Belleville Memorial Hospital
01.2012 - 07.2014
Lead Medical Technologist, Microbiology
VA Medical Center
10.2010 - 01.2012
Medical Technologist, Microbiology
Bonsecours Health Center
08.2007 - 04.2010
Medical Technologist, Microbiology
US Navy
07.2003 - 07.2007
Masters - Public Health
Eastern Virginia Medical School
Masters - Science
Old Dominion University
Doctor of Health Science -
AT Still University