PHARMACOVIGILANCE & MANAGEMENT
- 20 years of global clinical trial management in oncology, neuroscience, anti-infective, and ophthalmology.
Protocol Writing/Feasibility, Clinical Supply Chain, CTA Application, Statistical Analysis Plan, Strategic Vision and Planning, Data Management (OC-RDC), Patient Recruitment Plan, Clinical Monitoring, Consensus-building, Clinical Study Reports, Global Team Management, Contract and Vendor Negotiation, Large-Scale Budgets/Finance Plans, Compound Migrations/Transitions, Risk Analysis and Assessment, Project Management, Process Streamlining, and Team Leadership.
Director of Clinical Operations, Euthymics Bioscience, Neurovance, Inc.
Design operational protocols, clinical development plans, budgets, and operations documents. Conduct vendor and consultant selection and contract negotiations, oversight, risk assessment and mitigation, planning monitors, project management, medical writing, programming, statistics, and regulatory reporting. Manage relationships with opinion leaders, medical directors, boards of directors, and regulatory officials. Participate in leadership management team; lead clinical project team meetings. Devise processes for tracking primary endpoint, finance, timelines, training, TMF, and pharmacovigilance. Develop data and graphic reports for investors, and board and poster presentations. Oversee clinical supply manufacturing and labeling.
Consultant Clinical Program Manager – Alzheimer’s, Elan
Led EU study startup (FR, UK, SP), identifying previous startup constraints and preventing recurrences. Performed protocol and ICF review. Coordinated CA responses to ensure timely, accurate submissions. Developed processes and oversaw strategic partnership, metrics, recruitment and retention plans, and accountability, as well as sponsor process for reviewing MVR.
Consultant Study Manager – Oncology, Eisai
Provided ad hoc support to early development Phase 1-3 clinical trials, INDs, sNDAs, NDAs, and MAA. Reviewed patient profile data and correlated FDA responses, working with CROs and central readers. Global SM for compassionate use study in EU and Canada, identifying and uplifting startup constraints. Led the efficient, cost-effective close-out legacy long-term safety follow-up studies across the operation.
Global Clinical Study Manager/Associate Director (Oncology, HIV, Ophthalmology, Pain, Inflammation), Global Clinical Program Operation Manager (Pain and Neurology), and Global Clinical Database Associate (Anti-infective), Pfizer, Inc.
Managed global phase clinical trials, FIH/FIP, and non-interventional studies across therapeutic areas. Conducted protocol feasibility and country/site selection; forecasted clinical supply; and provided budget, contract negotiation, study start-up and conduct, and vendor oversight. Developed strategic recruitment plans, risk analysis, and contingency plan. Organized Scientific Steering Committee and Investigator Meetings. Accomplished EC approval goal, per ECEMA. Designed and managed nine global clinical trials across multiple products and operational phases. Performed risk analysis and implemented contingency plans. Contributed to early compound development concepts, strategy, budget development, dosing regimens, and timelines. Mentored and provided oversight for eight study managers. Built and enhanced business partnerships with EORTC and KOLs. Aligned Pfizer and EORTC strategic goals, contracts, safety, and endorsement processes. Focused leadership team for consistency at Global Training Committee. Chaired local training committee, participating in data collection, processing, analysis and publication standardization, and developed tools, training curriculum, compliance calculation, SM checklist, and mentorship program for cross-therapeutic use. Managed global Campto program transition (12 sponsored and 300 supported trials) from Sanofi-Aventis. Collaborated with key stakeholders in safety, clinical, marketing, legal, and finance. Integrated key processes, identifying constraints and resolution in safety and supply chain. Updated contracts with CROs, independent research grants, and cooperative groups. Transitioned and reconciled global and local country multi-million dollar budgets and processes without disruptions to business, manufacturing, payments, and enrollments. Managed Petacc 3 adjuvant CRC for 30 countries and 3,278 patients. Developed translational research protocol aligning KOL and medical strategies. Partnered with medical writer on Clinical Study Report and final document QC. Facilitated Investigator meetings and DSMB; participated in Advisory Board Meetings and Petacc conference (defending Celebrex). Led the Lyrica global program and the development of a pain screening tool. Transitioned program from multiple international R&D sites to post-marketing. Facilitated collaboration for clinical, statistics, operations, outcomes research, and programming for data collection, cleaning, analysis, and reporting.
Clinical Pharmacology Data Manager, Hoffman La Roche
Clinical Data Coordinator, IBS and Diabetes, SmithKline Beecham