Stuart Boothman
Head of Clinical and Preclinical Studies @Sinclair
Signup · Get unlimited contacts
WORK HISTORY
Head of Clinical and Preclinical Studies @Sinclair
Cheshire West And Chester, GB
Responsibilities:• Initiation & leadership of several successful pre-approval & PMCF clinical studies assessing the safety & efficacy of aesthetic products products including LANLUMA, SILHOUETTE SOFT, MAILI, PERFECTHA and ELLANSE• Built & maintained strong, collaborative partnerships with CROs, investigators & cross-functional stakeholders to optimise study performance• Supervision of all biocompatibility activities within Sinclair. Designed, instigated & managed numerous studies in accordance with ISO 10993 to support medical device regulatory requirements & marketing strategies• Forecasted & management of multimillion-pound annual clinical & preclinical study budget. Construction of project business cases to assess financial feasibility• Comprehensive knowledge of scientific patents. Management of Sinclair Pharma’s extensive intellectual property portfolio & budget for 14 years• Drafted & reviewed PMCF & Clinical Evaluation plans & reports to fully meeting manufacturer obligations; enhancing post-market clinical evidence Achievements:• Created Sinclair Clinical Operations team and recruitment of team members. Developed and implemented new clinical study management SOP and operational processes, strengthening departmental quality controls & increasing compliance efficiency• Initiation and led of several successful pre-approval and post-marketing (PMCF) clinical studies assessing the safety & efficacy of dermatology, wound care & aesthetic products including LANLUMA, SILHOUETTE SOFT, MAILI, PERFECTHA and ELLANSE• Directed Project Team that achieved FDA IDE approval for ELLANSE S and planned & initiated ongoing multicentre pivotal clinical study and modular PMA submission• Prepared an extensive technical dossier that was instrumental in obtaining the approval of ELLANSE S dermal filler in the highly commercially valuable & strategically critical Chinese market• Conducted full suite of ELLANSE biocompatibility testing required for launch in US & China
EDUCATION
University of Liverpool
PhD, Biochemistry
Liverpool John Moores University
BSc (Hons) 2:1, Applied Biology
ABOUT STUART BOOTHMAN
Results driven leader with proven track record, always eager to acquire new knowledge• Highly experienced, knowledgeable & versatile scientific project leader with vast experience in biological research; wound care, dermatology & aesthetics• Dedicated, highly organised & innovative individual with extensive experience in R&D, clinical research and biocompatibility• Confident and accomplished communicator; a positive and energetic personality ensures strong and productive working relationships and successfully deliver projects• Fascinated by biology and nature loverSKILLS• Design & development of new product projects from early stage proof of principle through to product launch activities. Implementation of Design Control practices & procedures (ISO 13485)• Compiled & submitted comprehensive product technical files to regulatory authorities: US (FDA): 510k, IDE, PMA; EU (NB): CE Mark (MDD/MDR); China (NMPA/ CMDE) that met essential requirements and conformity assessments required for product launch• Initiation and led of several successful pre-approval and post-marketing (PMCF) clinical studies assessing the safety & efficacy of dermatology, wound care and aesthetic products including LANLUMA, SILHOUETTE SOFT, MAILI, PERFECTHA and ELLANSE• Performed detailed technology assessments for multiple new business development opportunities which have led to successful company acquisitions• Supervision of all biocompatibility activities within Sinclair. Designed, instigated & managed numerous studies in accordance with ISO 10993 to support medical device regulatory requirements & marketing strategies • Forecasting & ; management of multimillion-pound annual clinical & preclinical study budget. Construction of study & project business cases to assess financial feasibilityACHIEVEMENTS• Creation of Clinical Ops team & recruitment of team members. Developed & implemented new clinical study management SOP & operational processes, strengthening departmental quality controls & increasing compliance efficiency• Leadership of the Project Team that achieved FDA IDE approval for ELLANSE and planned & initiated ongoing multicentre pivotal clinical study & modular PMA submission• Prepared an extensive technical dossier that was instrumental in obtaining the approval of ELLANSE S dermal filler in the highly commercially valuable & strategically critical Chinese market• Technical Leadership role in the successful development & launch of global wound care products from the highly successful BIOPATCH (Ethicon), PROMOGRAN PRISMA, SILVERCEL & TIELLE ranges
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.