Julia Love is a Business Consultant with proven success helping global organizations in the life sciences industry improve productivity and profitability levels. Julia is a Duke University graduate with decades of clinical research contracting experience, earning a career reputation as an executive for both CRO and major biopharma companies. She has successfully led contracting for Clinical, Early Development, Central Labs, Clinical Pharmacology, FSP, and Market Access business units.

Julia leverages her experience on both the sponsor and vendor side to optimize the vendor selection and partnership process, knowing first-hand the necessity of the value in seeing the other party’s point of view to make outsourcing decisions and minimize the pain of the contracting process. Prior to joining TriRadial, Julia founded and managed her own consultancies, Love Contracts and Newbould / Love Strategies, supporting clinical vendor sourcing and contracting for small biotech, biopharma, and med device companies, saving her clients millions through innovative strategies and win-win negotiations.

Julia’s gained valuable CRO experience working at Quintiles (now IQVIA), where she started the Business Account Management (BAM) group to support key account contract deliverables, and then Covance (now Labcorp Drug Development and Fortrea), where she integrated all business unit contracts departments with customized consistent processes to drive contract execution, development and implementation of a tracking and forecasting application.

Julia came into the industry in R&D Finance at Glaxo (now GSK), ran their clinical contracts group, and was part of building their clinical outsourcing group, one of the first in the industry. Julia also headed groups at Duke Clinical Research Institute (DCRI) and ran Proposal and Contracts for a Site Management Organization. Working for Millennium/Takeda, Juliaserved as the lead clinical outsourcing rep for two strategic programs, headed study transitions to new partnership CROs. To learn more, visit Julia's LinkedIn Profile.

Julia lives in Durham NC with her husband Rob, rescue dogs Guster and Sir Barkleton Mix-a-lot (Barkley), and rescue cats Harold and SueAnn Nivens. When not working, reading, or cheering on Duke sports, Julia enjoys traveling, including visiting her three sons.

John is an accomplished Commercial Operations and Operations Excellence leader who has deep experience within the Medical Device and Pharmaceutical industries. He is able to bring to clients an Executive-level decision maker and industry perspective as well as broad experiences collaborating with business and functional business partners at all levels along with consulting, software and technology solution providers to optimize commercial capabilities and drive operational excellence.

John most recently worked as Vice President, US Region Commercial Operations at BD, a global medical technology company. There he led a team of ~400 associates in 10 different locations, supporting 8 business units and 2 enterprise commercial teams with capabilities in the areas of commercial and government contracting, sales reporting and analytics, sales operations, customer master data management, commercial technology enablement, operations excellence and integrations and divestiture project management. He led the initial formation of the Commercial Operations Center of Excellence (COE) stemming from the 2015 acquisition of CareFusion as well as the subsequent acquisition and integration with CR Bard in 2017. A significant part of the COE formation was working closely with his business unit, IT, HR and other functional business and industry partners to redesign the organizational structure, establish a new culture, implement new technologies and harmonize policies and processes to deliver significant cost savings.

Prior to joining BD, John held numerous leadership roles in the areas of program management, strategic account management, contracting and supply chain over an 11-year tenure at J&J in both their pharmaceutical and medical device segments. Earlier in his career, John held numerous roles at GE and Philips where he established his credentials in project and change management and continuous improvement, earning certifications as both a Master Black Belt and Black Belt in Six Sigma methodologies.

John holds a Bachelor of Science in Biomedical Engineering from Rutgers College of Engineering in Piscataway, NJ. He also serves as the Board President for Community Hope, a non-profit organization that provides housing and support services to hundreds of veterans, veteran families, and people living with mental illness each year. John resides in New Jersey with his wife Sandy and their yellow Lab Maddie. They have two adult children, Jessica and Michael, that they enjoy visiting as often as possible and also enjoy traveling and hiking with Maddie.

A consulting leader and advisor, Ken is passionate about transforming the processes and tools used to bring new therapies to market.  Ken brings a broad perspective on current and future state processes and technologies used in drug development by sponsors, sites, CROs, and patients.  As a life sciences consulting executive, Ken has worked with the majority of top-20 pharmaceutical companies, along with numerous biotechs, CROs, and academic research centers.
 
For 30 years, Ken has led organizations focused on streamlining the clinical trials process through technology, strategy and process improvement.   Working with sponsors, sites, and CROs, Ken has overseen a wide variety of innovation and transformation initiatives.
 
Prior to joining TriRadial, Ken founded and managed his own consultancy, ClinScape, designed to bring technology strategy, innovation, and transformation to clinical trials.  For twelve years prior to that, as EVP of Corporate Strategy and Professional Services, Ken helped OmniComm Systems, a clinical technology innovator, build and grow until acquisition by a Private Equity group.  Ken has also led clinical implementation and strategy teams for BusinessEdge Solutions, First Consulting Group, and Oracle Corporation, where he oversaw the Oracle Pharmaceutical national consulting practice.  Ken has an M.S. in Computer Science from Fairleigh Dickinson University, and a B.S degree from the State University of New York at Binghamton.
 
When not leading consulting teams and initiatives, Ken loves to travel the world with his family and his wife Susan.  As a board member of the New Hope Historical Society, Ken can often be seen on Sunday afternoons giving walking tours to groups seeking to learn the rich history of New Hope.  He also enjoys digital photo journaling, pickleball, and for 30+ years has played touch-football every week, with a group of friends in his old neighborhood.

Solution Architecture and Innovation

Graham brings over three decades of experience in IT solution architecture, design and engineering to the table. His career is marked by:

• Steering advanced product development in diverse sectors.

• Creative solutioning through all phases of software development.

• Expertise in various methodologies, including agile and design thinking.

• Renowned for versatile technical proficiency and leading collaborative success.

• Fostering forward-thinking strategies and transformative digital solutions.

Special interest in the ideas and technologies to create Domain Specific Languages, Analytic Repositories, and Managed Data Lakes.

Decades of experience in the full SDLC with unique expertise using Agile practices to enable successful delivery. Typical project works spans everything from hands-on development to executive presentations.

Ramon (Ray) is a Senior Sourcing Consultant with deep expertise across a wide range of categories and processes. He has significant experience in Strategic Sourcing, both Direct and Indirect Procurement, and in use and implementation of procurement systems. His extensive line management experience and facilitation skills make him an ideal candidate to support full Sourcing Management, strategy implementation and supplier management.

Functional Expertise: Focused on Strategic Sourcing, Sourcing Transition, business process implementation, interim functional management, supplier management, and supplier relationship management. In these areas and more, Ray has consistently led teams to breakthrough results of 10% to 47% reduction in overall costs, as well as added significant value to the organization.

Sector and Category Experience: Ray’s sector experiences include the Retail, Healthcare, Hospitality, Aerospace, and Manufacturing. His category expertise lies in Facilities, Indirect, Direct, Capital, and Construction, categories. 

Professional Experience & Engagement Highlights

IT Services and SaaS: Supported negotiations for enterprise resource planning tools (Oracle/PeopleSoft, SAP, etc.), procure to pay and sourcing suites (e.g., Ariba, Zycus, etc.) working cross functionally with the IT teams; additionally provided category management oversight for Cloud, Big Data/Analytics, Customer Experience, Infrastructure Management, BPO, Digital Solutions, and social media spend categories

Complex Services: Sourced rail switching services and arranged to take over pre-departure inspection services yielding a net rebate of more than $500K per year

Process Improvement: Proper sourcing management process led to the delivery of a 47% reduction in telecommunications cost at the corporate level for one company

Sourcing Transformation: Led Strategic Sourcing implementation for MRO and Manufacturing support services at food processing client

Qualifications and Achievements

• Master’s in Business Administration – Dowling College
• BS in Economics – State University of New York at New Paltz
• Certified Purchasing Manager (C.P.M.) – Institute for Supply Management

Meryl is a Senior Consultant with TriRadial Solutions, a consulting organization supporting the biopharmaceutical industry with vendor outsourcing, optimization and oversight, CAPA optimization, audit and inspection readiness, and process and procedure development. She was formerly the Senior Director of CRO Services and Vendor Management at ProSciento, an early phase CRO specializing in metabolism studies, responsible for building the CRO division and for the development and execution of key strategies supporting growth and continued development of CRO operations. 

She has been a consultant to the biopharma industry across her career in areas of Quality Assurance, vendor management, outsourcing, and business process optimization.  Meryl was the VP of Quality Assurance and Business Excellence for Synteract global CRO where she led the global QA group, participated in integration and global harmonization activities and enhanced quality processes.  

In earlier roles, Meryl was the Director of Strategic Outsourcing for Teva Pharmaceuticals, Bristol Myers Squibb and Amgen (originating the departments for BMS and Teva) and built standardized outsourcing processes as well as a structure for vendor governance.  Meryl has worked for several central laboratories, including LabCorp, MDS Pharma, Quest Diagnostics and ACM, in functions including Project Management, Operations, Quality, client relationship management, global harmonization and Biorepository management.  During her 19 yr tenure at Bristol‑Myers Squibb, she was instrumental in the conceptualization, implementation, growth and marketing of the BMS Clinical Laboratory, in support of Phase I-IV trials.  

Meryl holds a BS in Medical Technology from Rutgers University and an MBA from Fairleigh Dickinson University.

Dr. Rick Sax earned his B.A. degree in Biology and Philosophy from Yale College (1977), summa cum laude, and completed his medical degree at Columbia University’s College of Physicians & Surgeons (1981). Dr. Sax received his board certification in Internal Medicine after completing his residency training at The New York Hospital/Memorial Sloan-Kettering Cancer Center. He then served as a Staff Fellow in the Cardiology Branch of the National Heart, Lung and Blood Institute at the National Institutes of Health and completed his cardiology fellowship at Johns Hopkins University Medical Center, becoming board-certified in Cardiovascular Diseases in 1989. Dr. Sax was an Assistant Professor of Medicine and Assistant Director of the CCU at the Cornell University Medical Center from 1988-1991.

In 1991, Dr. Sax joined Merck Research Laboratories where he led the team responsible for successful development and registration of the antiplatelet agent, AGGRASTAT®. He subsequently became the Head of Clinical Cardiovascular Research with responsibility for global cardiovascular research programs at Merck. He served on the Worldwide Business Strategy Team for Hypertension & Heart Failure, then led the Antiplatelet/Antithrombotic Worldwide Business Strategy Team. In 2001, Dr. Sax joined AstraZeneca as Vice-President for U.S. Clinical Research, overseeing the physicians and medical writers. In 2003, he created and took on the new role of Vice-President for U.S. Strategic Development, responsible for the interface between the global Development organization and the U.S. commercial business. Following the restructuring of global Clinical Development in 2005, Dr. Sax took on responsibility for global Medical Sciences. He then helped create and served as the Clinical representative to the New Opportunities group, followed by a leadership role in re-designing AstraZeneca Clinical Development, with a particular focus on building a new approach and capabilities for design and interpretation of clinical programs.

Dr. Sax left AstraZeneca in 2011 and joined Quintiles as the Senior Vice-President for Integrated Clinical Services, encompassing the Quintiles Laboratory, global Safety, Biostatistics, Medical Writing, and Regulatory services. He was responsible for building Quintiles’ planning & design unit, the Center for Integrated Drug Development, which became part of Quintiles Advisory Services in 2014. With the merger of Quintiles and IMS to become IQVIA, the business evolved into the Strategic Drug Development group, focused on integrating data and deep domain expertise to support companies with due diligence activities and creating strategic development, regulatory, and commercial plans for their assets.

Dr. Sax “retired” from IQVIA in the Spring of 2019 to form his own consultancy practice, Pharma Design Solutions, Ltd. His current work focuses primarily on supporting companies with novel, innovative technology solutions that can be used to improve pharmaceutical R&D efficiency and productivity, but also be applied more broadly as health science solutions.

Raphaële is an expert in Outsourcing Management, Vendor Relationship Management, Vendor Quality Oversight and Business Process Development and Optimization.  She consistently focuses on enhancing performance throughout Clinical Development.

At TriRadial Solutions, Raphaële advises companies on how to develop and enhance their vendor sourcing strategies, their vendor oversight capabilities, and their quality risk management activities so that clinical studies are delivered on time, on budget and with high quality. Raphaële also ensures a tailored implementation by delivering customized processes, tools, coaching and training for client teams, within a change management approach that matches the client’s unique environment.

Raphaële brings 25 years of experience, mostly with Bristol-Myers Squibb (BMS), where she held various international management positions in Global Clinical Operations, Productivity and Quality Management, Strategic Sourcing and Vendor Outsourcing Management. During her career, Raphaële developed global and local sourcing strategies and driven complex bidding/negotiations.  Raphaële focused on improving relationships with preferred strategic external partners (Contract Research Organizations (CROs), Central, Biomarker and Core Laboratories) through implementing strategic and operational governance structures/committees, quality agreements, Service Level Agreements, performance metrics, and continuous improvement initiatives.

Sharing experiences, learning from others, coaching, training and developing fit-for-purpose processes and tools to enhance Clinical Operations effectiveness for our clients is what Raphaële enjoys most with TriRadial Solutions.

Mike is an R&D transformation leader and trusted advisor with almost 30 years of life sciences qualifications in:  

• Global regulatory strategy, operations and alignment
• Process optimization and mapping
• Drug and biologic development process transformation
• Product license transfer authority
• Medical Affairs (call center, MSLs)
• Pharmacovigilance and Safety operations
• Clinical technology development and program manager

After getting her B.S. degree in Medical Technology, Vickie worked for several years in diagnostic, research and industrial QA labs. Her extensive lab experience led her into laboratory sales to both medical and corporate labs across many industries. That insight and experience served as a great foundation as she became a business solutions consultant, focusing on document centric processes and helping clients to automate those with workflows and document repositories. Vickie found she had a passion for organizational excellence – project management, knowledge management, document management.

During her early consulting years, Vickie’s successful project accounts included:

• Aventis Pasteur (now Sanofi)
• GE Aircraft
• InterGen Energy
• Lord Corporation
• PEMEX (Petroleos Mexicanos) and
• PPD (Pharmaceutical Product Development, Inc.)

The project with PPD introduced her to the CRO (Contract Research Organization) world and led her to join Quintiles in 2003.  Vickie served as the Strategic Business Partner within the newly launched Corporate Strategic Services (CSS) for several business units and functions, helping leaders to develop strategic plans and objectives, aligned to the corporate strategy and to identify initiatives to close performance gaps.  Following the launch of CSS, Quintiles realized double digit growth, year-over-year, which enabled their second IPO in the company history.  In later years Vickie led the development of Quintiles’ Change Management Office and co-created Quintiles’ Change Implementation methodology and playbook.

Areas of her passion and expertise:

• Strategy Development – defining an achievable, but stretch, long term goal and defining how to get there with actionable objectives
• Strategy Management – monitoring the progress of strategic objectives through metrics, management reviews and continuous oversight; involves identifying the owners for each strategic theme and objectives and then their accountability for the oversight – knowing how things are going through data analytics, feedback loops, etc.
• Strategic Initiative Portfolio Management – the identification of potential initiatives, review and prioritization of those potentials and then tracking progress through portfolio reviews
• Change Management – creating and deploying change implementation methodologies and tools tailored for specific client’s needs to achieve successful adoption of changes delivering expected business benefits

Jonathan has more than two decades of operational and consulting experience across the comprehensive life sciences and health care spheres, spanning pharma, biotech, providers, and services. He has helped clients address corporate growth strategy, digital capabilities, marketing, asset acquisition, and financial controls.

His foremost client engagements have included:

• Transformation of outsourcing strategy of a leading US biotech
• Implementation of an asset acquisition and due diligence strategy for large pharma entering new markets
• Established research infrastructure for leading academic medical center in Saudi Arabia
• Enhanced financial insight and control of outsourcing partners for leading EU biotech 

Prior to joining TriRadial, Jonathan led growth strategy and strategic partnership efforts for Covance and Chiltern, co-founded a Health Sciences Solutions consulting practice, and served as a Principal in the R&D Advisory Practice and Global Project Manager at IQVIA (formerly Quintiles), leading clinical development efforts across multiple therapeutic areas. 

Jon holds an MBA from the University of North Carolina at Chapel Hill’s Kenan-Flagler Business School with a concentration in strategy and leadership and a BA from the University of Delaware. In his personal time, Jon spends time with his wife, Alison and their two kids, coaches youth soccer, and trains martial arts.

Since 2003 Tomasz has worked as a GCP QA Auditor collecting vast experience in drug developing organizations such Phase 1 / BE unit, CRO, Innovative Big pharma, small biotech, in EU and outside EU countries. He specializes in clinical site GCP audits for trials of all phases (I to IV) and system, sponsor oversight, and vendor audits (systems), especially in Phase1 units' assessment.

One of his leading activities is sponsor and site preparation for regulatory inspections (EMEA, FDA) through conducting training, pre-inspections audits, acting as an inspector during mock-inspections, and sponsor's representative.

Dr. Kosieradzki has been using his expert knowledge and experience as a trainer/lecturer in various training projects and as a speaker for several industry conferences throughout Europe for the past ten years.

Tomasz is an MRQA - member of the Research Quality Association (former BARQA) and Polish GCP Society.

His strong advantage is the knowledge and experience in developing practical and fit-to-purpose Quality Management Systems (QMS) based on process mapping methodology.

Expertise in:

• Quality Management Systems in clinical trials according to ICH-GCP E6
• Sponsor Oversight - complex approach
• QMS according to ISO-15189-2012 Medical Laboratories - Requirements for Quality and Competence
• Auditing methodology, including practical knowledge of industrial and regulatory referential documents for clinical trials
• Preparation and hosting of regulatory inspections, including mock inspection
• Early Development (Phase I) auditing (trials and vendors)
• Risk-based approach to monitoring and auditing
• Risk Management
• Systems and Clinical Sites Audits
• Vendor evaluation
• SOP writing
• Gap analysis in clinical research and due diligence
• Root-cause analysis of errors
• Corrective and Preventive Actions - training

As a technology and operations leader, Antonio has a track record of accelerating business outcomes for international enterprises and Fortune 500 companies. His achievements include the turn-around of under-performing organizations to: restore profitability, increase efficiency, and develop leading-edge software applications – from concept through release.

Antonio led the team that developed DataForm Software's flagship product, Planet Life Cycle – a robust work management application that merges strategic and financial planning with execution. As a direct result, customers that are global leaders, such as Allergan Pharmaceutical, have leveraged the solution to enhance their competitiveness. Antonio is consistently striving to enable customers to achieve operational excellence. In his words, “When our customers win, we win."

CORE COMPETENCIES

• Operational Leadership
• Budget and Financial Management
• Software Design and Development
• Technology Strategy and Execution 
• Business and Technology Alignment 
• Process Refinement and Improvement
• Re-Structuring and Change Management 
• System Re-Engineering and Optimization 
• Client Acquisition and Relationship Building
• Growth Planning and Performance Measurement 

John’s experience spans more than 30 years across life sciences, pharmaceutical product development, clinical trials, and healthcare. His work focuses on clinical development process optimization, covering the entire development lifecycle from concept to approval to withdrawal. Recent work has centered on global development transformation to streamline workflows, improved efficiency, and optimize cross-functional collaboration. By focusing on a collaborative approach, teams can bring key voices together earlier in processes, through better planning and workflows – to achieve more robust work products and a ‘right the first time’ approach. This can result in greater cross-functional interactions that move work through the lifecycle faster with higher quality and in a more compliant manner. 

Prior work has included regulatory process redesign, global product asset transfer strategies, and streamlining a development organization spanning R&D, surgical and consumer products. 

John started his career in healthcare at The Cleveland Clinic Foundation. His work then expanded into clinical trial technology and EDC with work at DATATRAK, where he led clinical implementation services. From there he entered consulting with BusinessEdge Solutions/EMC, before moving to Quintiles/IQVIA in the Consulting Services organization and later Global Regulatory Affairs. In 2019 he partnered with TriRadial Solutions to further process optimization for pharma, biotech, and device companies. 

In his free time, John enjoys seeing and experiencing the world. Experiencing new places, cultures, and cuisines is very important to him to help broaden his worldview. He also is an accomplished home chef, enjoys entertaining and spending time at home with family and his three cats.

Matt is a management Consultant with significant experience working with clients at strategic and tactical levels.  Known for helping clients zero in on the most critical elements of their problems, Matt develops creative solutions and then takes a disciplined and practical approach to get the job done. 

Matt has a strong collaborative leadership style adept at working across Information Technology, R&D, marketing, and operations in the pharmaceutical, biotech, and manufacturing industries to achieve results.

Matt is part management consultant, known for getting cross-functional teams to cut out the buzzwords, get real, and tackle tough problems. He is also part entrepreneur, bringing the much needed concepts of high performing teams, business agile and psychological safety to the hospitality industry.

Full time, husband, father, and wiseacre.

With over 20 years’ experience in the global life sciences industry, Pasi is a deep subject matter expert in Procurement and Finance and how those areas help enable world class R&D organizations.  Most recently he was the Head of Procurement at Actelion Pharmaceuticals (today part of the Johnson & Johnson Family of Companies). 

Pasi has a MSc in Industrial Economy from Lappeenranta University of Technology in Finland and holds the Chartered Financial Analyst (CFA) designation. Pasi’s passion is to promote and discover new solution via digital innovation and organizational design that helps the procurement to move to the next era. 

With over 30 years’ experience in the global life sciences industry, Ulrike has extensive experience in senior strategic and operational oversight of worldwide clinical trial management teams in a global CRO setting. Currently she is focused on CRO selection from proposal stage to budget, Workorder and MSA negotiations. 

Prior to her consulting work, Ulrike spent over 23 years working for Parexel in a global leadership capacity. Ulrike holds a Ph.D. and MSc in Biology/Chemistry from Heidelberg University in Germany. Ulrike’s passion is to assist clients achieve key operational and financial targets while going through notable change.