STEPHANIE J. ZAFONTE, DNP
Clinical Development & Operations | Global Oncology, Immunology, Neurology, & Rare Diseases Programs
Derwood,MD
Summary
Accomplished clinical development and operations leader with global expertise in managing Phase I-IV programs in oncology, rare disease, immunology, and infectious disease. Led study design, feasibility assessments, and cross-functional collaboration to ensure compliance and successful program delivery in diverse markets. Excelled in balancing strategy, risk, timelines, and budgets.
Overview
1
1
Certification
18
18
years of professional experience
Work History
Associate Director, Clinical Development & Operations (Consultant)
Daichi Sankyo
Basking Ridge, New Jersey
08.2025 - 07.2026
- Provided strategic clinical development input for high-priority global programs, enhancing study design, feasibility, and execution planning
- Partner with global study leaders and cross-functional stakeholders to align clinical strategy with regulatory and business objectives
- Contributed to clinical program strategies, focusing on risk assessment, country selection, and operational models to optimize program outcomes
- Supported governance interactions by developing business cases, timelines, and program-level recommendations that informed decision-making
- Provided clinical operations and scientific expertise to the project (e.g., country selection, feasibility, operational input into design, risks, and external partner management) using new innovative design and delivery models to support governance interactions. 32Q.
Global Program Director, Clinical Development & Operations (Consultant)
AstraZeneca
Gaithersburg, MD
07.2023 - 04.2025
- Led global clinical programs across oncology and rare disease indications, including Phase I-III studies across 18-20 countries
- Developed clinical development strategy, focusing on study design, endpoint considerations, and program feasibility to enhance project outcomes
- Oversaw program delivery, ensuring alignment with governance expectations, timelines, and quality standards to drive successful project execution
- Partnered with regulatory, medical, and commercial stakeholders to align development plans with asset strategy
- Leveraged clinical operations expertise to develop business case opportunities for governance review, addressing cost, timelines, quality, feasibility, and risk.
Senior Director, Clinical Development & Operations
Medicago, Inc
, Canada
08.2021 - 04.2023
- Led clinical development and execution for multiple programs, overseeing a portfolio of 8 clinical trials and a team of 30+
- Directed development planning, including protocol strategy, clinical study design, and regulatory documentation
- Collaborated with executive leadership to align clinical programs with corporate and pipeline strategy
- Ensured successful delivery of clinical milestones through proactive risk management and strategic decision-making
- Managed study timelines, budgets, and resource allocation to ensure on-time, on-budget delivery of high-quality study results
- Oversaw regulatory submissions and study reports, streamlining cross-functional integration across clinical, regulatory, and quality teams.
- Established collaborative partnerships with investigators, regulators, and stakeholders, enhancing vendor selection and management accountability.
Clinical Operations Lead / Clinical Development Operationsr (Consultant)
Moderna, Therapeutics
Boston, MA
08.2020 - 08.2021
- Facilitated development and execution of global COVID-19 vaccine clinical programs, ensuring inclusion of special populations
- Participated in clinical strategy discussions and study design, enhancing execution planning for accelerated development timelines
- Partnered with senior leadership to ensure alignment with regulatory expectations and rapid program delivery
- Developed innovative early warning systems to identify potential obstacles to project completion, analyzing information and creating solutions for timely project delivery using MS Suite and Smartsheets.
Project Director, Global Clinical Programs
IQVIA Biotech
Morrisville, NC
05.2017 - 08.2020
- Led global development programs from initiation through closeout, managing large-scale, multi-region trials
- Collaborated with sponsors to ensure alignment of clinical execution with development strategy and regulatory expectations
- Identified project trends and managed risks with mitigation strategies and quality management systems
- Directed risk management and quality management systems to enhance project execution and continuous improvement of business processes
- Negotiated with clients and vendors to ensure that the work was scoped and completed in accordance with agreements/contracts.
- Played key role in bid defenses and strategic program positioning for new business opportunities
Senior Project Manager
PPD, Inc
Wilmington, NC
02.2016 - 05.2017
- Led full-scope global projects with budgets over $50M, providing senior leadership to remote and global teams of 50+ members in a matrix environment, and utilizing project management systems and timelines.
- Led study operations globally with financial and contractual oversight, ensuring quality deliverables and developing processes to overcome study-specific or local regulatory challenges.
- Strategically managed stakeholders and companies to secure and integrate their contributions to studies, resulting in streamlined processes and timely completion of study milestones.
- Managed proposal and start-up phases of studies, coordinating with site intelligence teams and regulatory affairs to navigate regulatory challenges.
Research Enterprise Consulting Manager
Huron Consulting Group
Chicago, IL
01.2015 - 10.2015
- Orchestrated the development, initiation, activation, and execution of a multi-organizational oncology study involving three distinct patient care settings and several institutional departments naïve to conducting clinical research.
- Coordinated with healthcare professionals, including physicians, research coordinators, and pharmacists, to facilitate smooth study operations and ensure compliance with regulations and protocols.
- Evaluated and recruited patients for clinical trials, confirming eligibility criteria and providing study information while obtaining informed consent.
- Developed and delivered orientation and training for newly hired research nurses and hospital nurses, enhancing their preparedness to care for study participants.
Nurse Consultant / Clinical Project Manager, Enteric and Hepatic Diseases Branch (EHDB), Division of Microbiology and Infectious Diseases (DMID)
NIAID, NIH
Bethesda, MD
11.2009 - 01.2015
- Developed and managed study budgets, ensuring cost-effective use of resources, and maintained study timelines to achieve milestones and project goals Successfully led global remote teams of 10 to greater than 50 members across multiple functional areas, companies, investigative networks, and vendors to develop study proposals and execute projects, resulting in high-quality and compliant delivery.
- Led relationship-building with internal stakeholders, regulatory bodies, and project partners; mentored new employees and contributed to scientific and strategic planning addressing emerging health needs and evolving therapeutic landscape.
- Reviewed and evaluated grant proposals and progress reports; planned risk management and mitigation strategies and ensured compliance with regulations and GxP across diverse funded portfolio.
- Created and finalized research protocols and related documentation to ensure compliance and clarity.
Director of Research and Communication, Medical Product Safety Network (MedSun) FDA CDRH Contract, Public Health Research Group
Social & Scientific Systems, Inc.
Silver Spring, MD
01.2009
- Led a team of 5 members to support the MedSun initiative, providing senior leadership for operations, clinical direction, and surveillance oversight to ensure effective implementation of FDA safety and risk management initiatives.
- Proactively identified signals from reported events and followed up with studies to identify the nature, extent, and impact of possibly malfunctioning devices, providing essential evidence for recalls by the FDA.
- Directed interventions in communications, research, and evaluation of safety issues identified through surveillance, ensuring prompt identification and resolution of safety concerns.
- Facilitated accurate and timely reporting of events from facilities regarding post-marketing devices, enhancing data collection processes.
Education
Doctor of Nursing Practice (DNP) - Leadership & Management
George Washington University
Washington, DC01-2015
Master of Science in Nursing (MSN) - Clinical Research Administration
George Washington University
Washington, DC01-2007
Bachelor of Science in Nursing (BSN) -
University of Maryland Baltimore
Baltimore, MD01-1988
Skills
- Clinical trial design
- Resource allocation
- Fiscal oversight
- Decision-making
- Strategic leadership
- Key relationship management
- Team leadership
- Organizational development
Certification
Registered Nurse (RN), Maryland
License No. R100432 | 1988Present, Certified Contractor Representative (COR)
U.S. Federal Government | 20072015, Certified Clinical Research Professional (CCRP)
Society of Clinical Research Associates (SoCRA) | 20032022, Certified Quality Auditor (CQA)
American Society for Quality (ASQ) | 20052009, Regulatory Affairs Certification (RAC)
Regulatory Affairs Professionals Society (RAPS) | 20062009
Accomplishments
- Led global clinical programs across oncology and vaccines, overseeing portfolios exceeding $300M, driving delivery of multiple late-phase and registration studies
- Directed development strategies across 8+ global trials (Phase I-III) spanning 20 countries and 250+ sites
- Partnered with senior leadership and governance bodies to shape clinical development pathways, feasibility strategies, and investment decisions
- Ensured sustained inspection readiness and regulatory compliance, successfully supporting FDA audits and global regulatory expectations
- Built and led high-performing global teams (50+), driving execution excellence and cross-functional alignment across complex development programs
- Served by invitation as a Board of Director for the SoCRA.
- Therapeutic expertise includes oncology, immunology, infectious diseases, cardiovascular, rare diseases, critical care, adults, pediatrics for FIH-Phase IV programs.
CORE LEADERSHIP CAPABILITIES
- Clinical Development Strategy & Execution
- Global Clinical Program Leadership (Phase IIV)
- Regulatory Strategy & Health Authority Engagement
- Oncology & Rare Disease Development
- Cross-Functional Leadership (Medical, Regulatory, Commercial)
- Portfolio & Asset Lifecycle Management
- Governance & Executive Decision-Making
- Risk Mitigation & Inspection Readiness
Timeline
Associate Director, Clinical Development & Operations (Consultant)
Daichi Sankyo
08.2025 - 07.2026
Global Program Director, Clinical Development & Operations (Consultant)
AstraZeneca
07.2023 - 04.2025
Senior Director, Clinical Development & Operations
Medicago, Inc
08.2021 - 04.2023
Clinical Operations Lead / Clinical Development Operationsr (Consultant)
Moderna, Therapeutics
08.2020 - 08.2021
Project Director, Global Clinical Programs
IQVIA Biotech
05.2017 - 08.2020
Senior Project Manager
PPD, Inc
02.2016 - 05.2017
Research Enterprise Consulting Manager
Huron Consulting Group
01.2015 - 10.2015
Nurse Consultant / Clinical Project Manager, Enteric and Hepatic Diseases Branch (EHDB), Division of Microbiology and Infectious Diseases (DMID)
NIAID, NIH
11.2009 - 01.2015
Director of Research and Communication, Medical Product Safety Network (MedSun) FDA CDRH Contract, Public Health Research Group
Social & Scientific Systems, Inc.
01.2009
Doctor of Nursing Practice (DNP) - Leadership & Management
George Washington University
Master of Science in Nursing (MSN) - Clinical Research Administration
George Washington University
Bachelor of Science in Nursing (BSN) -
University of Maryland Baltimore