CAROL LEWIS-CULLINAN
Chepachet,RI
Summary
Clinical Operations leader with over 25 years of experience in managing global pharmaceutical and biotech programs from preclinical stages to regulatory approvals. Expertise in leading cross-functional teams and external partnerships to ensure projects are completed on time and within budget. Proficient in due diligence, asset strategy, and data-driven decision-making to enhance R&D portfolio value. Committed to operational excellence and regulatory compliance while fostering high-performing teams and innovative trial designs.
Overview
13
13
years of professional experience
Work History
PRINCIPAL
CAROL LEWIS-CULLINAN CONSULTING, INC.
Glocester, USA
04.2022 - Current
- Provide strategic Clinical Operations and Program Management services across the lifecycle, aligning outsourcing, timelines, resources, and deliverables with client objectives and ICH-GCP requirements.
- Lead multi-stakeholder planning and execution for clinical development plans, balancing internal capabilities with external outsourcing to drive on-time, on-budget delivery.
- Serve as executive coach and advisor to clinical operations leadership, advancing governance, process improvements, and talent development across client teams.
- Act as primary liaison for biotech collaborators and CROs, shaping collaboration strategies, risk/benefit considerations, and study design input to ensure value creation and partner satisfaction.
VP/HEAD, GLOBAL CLINICAL OPERATIONS, GLOBAL CLINICAL DEVELOPMENT
PROLACTA BIOSCIENCE
01.2023 - 10.2024
- Led global Clinical Operations for sponsored trials, ensuring adherence to timelines, budgets, and regulatory compliance (ICH-GCP) across the portfolio.
- Shaped outsourcing strategy and alliance management, building and maintaining strong relationships with CROs, vendors, and external partners to optimize clinical workflows.
- Guided growth and change management within Clinical Operations, driving system builds, process standardization, and implementation of essential GCP processes.
- Managed financial planning for clinical operations (accruals, quarterly forecasting) and ensured operational feasibility of development plans.
- Collaborated with KOLs and cross-functional R&D teams to align study design and risk/benefit considerations with asset strategies.
- Fostered an inclusive, high-performing team culture, emphasizing health and well-being while pursuing ambitious project goals.
VICE PRESIDENT/HEAD, GLOBAL CLINICAL OPERATIONS, GLOBAL CLINICAL DEVELOPMENT
SANIONA, INC.
08.2020 - 04.2022
- Built and led global Clinical Operations to support the full scope of clinical development programs, including adaptive and high-touch trial designs with early data generation.
- Contributed to the design, planning and execution of innovative clinical trial designs and overall global clinical and regulatory strategy that resulted in the authoring and filing of three successful regulatory submissions (2 INDs and 1 CTA), two successful Orphan Drug Designations (ODD) and over 20 Competent Authorities and Ethics submission in support of global trials footprint.
- Directed operations, vendor/CRO management, and alliance activities to ensure timely, within-budget, compliant execution of sponsor trials.
- Led development and execution of Quality Management System (QMS) and GxP processes to support inspection readiness and regulatory compliance.
- Played a key role in strategic outsourcing, financial planning, and resource allocation, guiding cross-functional teams through growth and change management.
- Contributed to asset strategy development and due diligence for potential collaborations; worked with R&D and Clinical Sciences on trial designs and regulatory strategy.
- Drove collaboration with external partners (CROs, biotechs) to ensure alignment of goals and prioritization of patient-centered outcomes.
SENIOR CLINICAL CONSULTANT
BIOBRIDGES, INC.
11.2018 - 08.2020
- Provided end-to-end clinical program management: study design, protocol writing, SOP development, medical writing, and regulatory submissions.
- Executed vendor oversight, cross-functional coordination, budget management, and regulatory compliance (US/EU) including inspections.
- Built infrastructure through SOPs and process development; ensured feasibility and alignment of clinical development plans with regulatory requirements.
- Led external collaborations and alliance activities with CROs and vendors, contributing to efficient trial execution and readiness for inspections.
VICE PRESIDENT/HEAD, GLOBAL CLINICAL OPERATIONS AND DATA MANAGEMENT
SERES, INC.
09.2014 - 11.2018
- Oversaw all Seres sponsored clinical trials, ensuring on-time, on-budget delivery and adherence to regulatory and corporate quality standards.
- Led functional teams across Clinical Operations and Data Management, serving as the SME for internal operations and external collaborations.
- Collaborated with R&D and Clinical Sciences to design and execute innovative trial designs and regulatory strategies, contributing to multiple regulatory filings.
- Coordinated with external collaborators, CROs, and vendors to optimize trial execution, data integrity, and study efficiency.
- Implemented process improvements and performance metrics to drive operational excellence and improve study outcomes.
SENIOR DIRECTOR/HEAD, GLOBAL CLINICAL OPERATIONS
FORUM Pharmaceuticals
03.2012 - 09.2014
- Management of Clinical Operations staff and study oversight; 32 personnel; 4 compounds with 6 Global Phase 3 trials, 2 Global Phase2 trials and 8 Phase 1 trials in various stages of execution.
- Responsible for the financial management of the $100 MM+ trial budgets.
- Member of FORUM Development Leadership Team, providing ongoing management reports to Executive team. Drive a performance driven culture across the region while also heavily working on resource planning to maintain appropriate headcount.
- Responsible for operational decision making, problem solving and strategic implementation and execution of global clinical trials in support of the products in development at FORUM.
- Directed procurement and management of all external service providers for the conduct of all clinical trials in support of the products in development at FORUM.
- Oversaw CRO management the production of clinical project plans and study designs, will maintain study budgets, and will ensuring studies are conducted according to GCP and industry standards.
- Served at interim study lead for Phase 3 program during a 6-month medical leave of a CTM conducting Clinical Operations activities to include trial design, vendor selection, contracting, site selection, vendor management, and study conduct.
Education
Master of Science - Nursing
Nursing
University Of California, San FranciscoMaster of Strategic Studies -
US Army War College
Certified Family Nurse Practitioner -
University of Califronia, San Francisco
Project Management Certification -
Boston University
Master Gardner Certification -
University of Rhode Island
Skills
- Global Clinical Operations
- Program Management
- Cross-Functional Leadership
- ICH-GCP Compliance
- Regulatory Submissions
- SOPs
- Budgeting
- Forecasting
- Resource Allocation
- Study Design
- Protocol Development
- Data Management
- Vendor Management
- CRO Management
- Outsourcing
- External Collaboration
- Alliance Management
- Change Management
- Process Improvement
- Due Diligence
- Asset Strategy
- Portfolio Strategy
- Data-Driven Decision Making
- Risk Assessment
- Benefit Assessment
- Communication
- Stakeholder Management
- KOL Engagement
Additional Relevant Experience
- GENEXION, Inc, Senior Executive Director, North America Operations
- AVANT Immunotherapeutics, Inc, Senior Director, Clinical Operations
- SENTION, Inc, Director, Clinical Operations
- EMD Serono, Global Product Safety Specialist, Safety and Pharmacovigilance, Senior Clinical Project Manager
Military
1987-1994 United States Army Reserves
1994-2007: Rhode Island Army National Guard,
2007: Retired, Colonel; Rhode Island State Surgeon, Commander, Medical Detachment, Warwick, RI
References
References available upon request.
Timeline
VP/HEAD, GLOBAL CLINICAL OPERATIONS, GLOBAL CLINICAL DEVELOPMENT
PROLACTA BIOSCIENCE
01.2023 - 10.2024
PRINCIPAL
CAROL LEWIS-CULLINAN CONSULTING, INC.
04.2022 - Current
VICE PRESIDENT/HEAD, GLOBAL CLINICAL OPERATIONS, GLOBAL CLINICAL DEVELOPMENT
SANIONA, INC.
08.2020 - 04.2022
SENIOR CLINICAL CONSULTANT
BIOBRIDGES, INC.
11.2018 - 08.2020
VICE PRESIDENT/HEAD, GLOBAL CLINICAL OPERATIONS AND DATA MANAGEMENT
SERES, INC.
09.2014 - 11.2018
SENIOR DIRECTOR/HEAD, GLOBAL CLINICAL OPERATIONS
FORUM Pharmaceuticals
03.2012 - 09.2014
Master of Science - Nursing
Nursing
Master of Strategic Studies -
US Army War College
Certified Family Nurse Practitioner -
University of Califronia, San Francisco
Project Management Certification -
Boston University
Master Gardner Certification -
University of Rhode Island
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