• Responsible for overseeing all clinical programs, including clinical operations, strategicplanning and study design activities for all pipeline products• Head of Quality Management and developed and implemented company QMS system.• Involved in development of key regulatory submissions, including Fast Track Designations,Orphan Drug Designations, Annual Reports, and IND Applications.• Implemented clinical outsourcing including selection of vendors, CROs, and otherexternal resources needed to successfully operationalize clinical development• Developed and approved all necessary clinical and regulatory documentation• Developed subject matter expertise with key opinion leaders in various therapeutic areas andmicrobiome research

• Lead medical team (clinical, medical affairs, pharmacovigilance and medical information)• Lead the company’s clinical strategy and provide expertise to the organization’s clinical research programs• Design and develop studies and oversee the execution of all clinical programs • Develop and maintain relationships with clinical key opinion leaders• Develop and maintain a clear vision of all programs and ensure communication of key objectives and milestones across the organization• Provide operational oversight and direction to vendors and guide cross-functional staff in support of assigned programs• Provide clinical support with regulatory communications• Support new product due diligence activities • Responsible for all clinical quality activities within the company

Lead, Project Manager (October 2014 - June 2016)Duties (amongst others):• Managed global project teams to initiate and coordinate all aspects of a clinical study.• Managed study team in the planning, implementation and successful completion of operational clinical research activities.• Collaborated with relevant departments to facilitate operational activities, including but not limited to: feasibility and risk assessment, development of study specifications/scope of work/logistics/project timelines for RFP development and bid defense, vendor selection/management and contract execution.• Ensured clinical trials were conducted in accordance with State and Federal regulations, ICH GCP and internal SOPs.• Managed and implement various company-wide process improvement initiates.• Provided leadership and training to various Project Operation members.• Successfully completed multiple FDA audits with no major findings.