Experience

Kedrion Biopharma

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Director, Global Clinical Research and Operations at Kedrion Biopharma

  • Sep 2022 - Present



Bio Products Laboratory Limited

• United Kingdom
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Senior Director, Global Medical Operations

  • Sep 2020 - Sep 2022



Bioventus

• United States
• Medical Device
• 700 & Above Employee

• Director, Global Medical Affairs Operations

  • Jan 2019 - Sep 2020



Bio Products Laboratory Limited

• United Kingdom
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Director, Global Medical

  • Apr 2016 - Dec 2018

  • Led global clinical research team and responsible to ensure all clinical trials are executed to plan and delivered on time and within budget • Managed clinical submission work to support product approvals and license variation applications including special protocol assessments (SPA), orphan drug and BLA submissions, FDA and MHRA RFIs, PIPs, USPI and SmPC updates, and post-marketing commitments • Personnel Management and Career Development for team of 7 • Created and embedded process improvements across medical department including CRO efficiencies, SOP management, vendor selection, budget forecasting, contracts and clinical processes • Ensured audit-readiness and GCP compliance across team and clinical studies • Led Pharmacovigilance’s delivery of audit responses across Quality, Regulatory, Medical and Commercial • Led Clinical Integration Workstream and implementation of quick wins • Provided clinical input into pipeline development discussions Achievements: • Initiated 2 clinical studies and completed 4 clinical studies to support ongoing registrations and commercial business • Managed clinical and submission work for 3 US FDA and EU submissions, leading to a successful product approval and extended labeling for an existing product • Recruited a clinical study 4 months earlier than planned which resulted in $1M of cost savings • Trained team and supported audit preparations for 6 FDA site inspections with no 483s Process Improvements and Efficiencies: • Implemented a new collaboration and Dashboard tool across the Medical Department, which was then adopted across the entire organization • Created a CRO RFP process and unit-based tracker which resulted in over 750k GBP of direct cost savings • Created a new clinical research career development structure and job descriptions to increase competencies and employee retention Show less



ICON plc

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director Project Management

  • Mar 2015 - Apr 2016

  • Responsible for effective management and leadership of global PMs, CTMs and CTAs to ensure overall delivery of Type 2 Diabetes Mellitus study in 12 countries, 170 sites • CRO budget totaling $27M and management of resourcing requirements • Business Development and Proposal Management • Active member of the Respiratory Center of Excellence committee to build therapeutic experience and product portfolio across the organization • Responsible for effective management and leadership of global PMs, CTMs and CTAs to ensure overall delivery of Type 2 Diabetes Mellitus study in 12 countries, 170 sites • CRO budget totaling $27M and management of resourcing requirements • Business Development and Proposal Management • Active member of the Respiratory Center of Excellence committee to build therapeutic experience and product portfolio across the organization



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Global Clinical Development Manager

  • Mar 2008 - Mar 2015

  • R&D Global Clinical Operations Lead • Delivery of 10k patient study across 38 countries, 1200 sites, 350 CRAs and 7 vendors which lead to successful launch of product (acknowledgment in NEJM 2018) • Global budget totaling $225M and management of 20+ vendor contracts • Managed a team of 8 regional study managers, vendor, country and stakeholder expectations through 3 study delays, multiple global feasibilities and vendor BID defenses • Partner with Health Outcomes team to deliver cognitive debriefing, ePRO, and translation of 51 languages • Planned and executed 12 Global Investigator Meetings within 8 months • Early Adopter of Risk Based Monitoring Pilot Additional Responsibilities: • Operations leader for 10 global and regional clinical trial programs. Responsible for long-term strategic planning, timely delivery of project plans, budgets, protocols, study reports and submission documents • Managed CROs and vendors including finalization of user requirements, user acceptance testing, and timelines • Strategic leader in regional and global settings, facilitating decision-making and encouraging contribution and collaboration • Led matrix teams through focused study designs that deliver on simplicity, productivity, and quality data for timely product registration • Managed global budgets ranging from $270k to $40M • Co-authored protocols and global informed consent forms Show less



Trio Clinical Research

• Research Triangle Park, NC

• Contract Study Manager (working at GSK)

  • Sep 2007 - Mar 2008



United Therapeutics Corporation

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Clinical Research Associate

  • Jun 2007 - Sep 2007

  • Phase III Pulmonary Hypertension Studies • Conducted Site Visits including 100% Source Document Verification, Case Report Form (CRF) review, query resolution, study drug accountability and shipment, and study file review • Phase III Pulmonary Hypertension Studies • Conducted Site Visits including 100% Source Document Verification, Case Report Form (CRF) review, query resolution, study drug accountability and shipment, and study file review



Constella Group (formerly Lineberry Research Associates)

• Research Triangle Park, NC

• Clinical Research Associate II

  • Aug 2004 - Jun 2007

  • Phase III Major Depressive Disorder, Generalized Anxiety Disorder, Bipolar Depression Studies • Conduct Site Visits including 100% Source Document Verification, Case Report Form (CRF) review, query resolution, study drug accountability and shipment, and study file review • In-house site management including primary contact for protocol inclusions and exclusions, out-of-range lab values, regulatory updates, advertising requests and rater training • Mentored and trained CRAs/CTAs • Phase III Major Depressive Disorder, Generalized Anxiety Disorder, Bipolar Depression Studies • Conduct Site Visits including 100% Source Document Verification, Case Report Form (CRF) review, query resolution, study drug accountability and shipment, and study file review • In-house site management including primary contact for protocol inclusions and exclusions, out-of-range lab values, regulatory updates, advertising requests and rater training • Mentored and trained CRAs/CTAs



American Kennel Club

• Non-profit Organization Management
• 200 - 300 Employee

• DNA Analyst

  • 2002 - 2004