Greater Philadelphia
I am a portfolio and project planning leader with deep experience supporting pharmaceutical R&D through disciplined scheduling, resource planning, and scenario-based decision support. In my role, I partner with asset and functional leaders to translate development strategy into executable, data-driven plans. My work sits at the intersection of strategy, execution, and governance. I excel at optimizing development timelines across complex portfolios, anticipating risks, resolving resource constraints, and enabling informed trade-off decisions that balance speed, cost, and quality. I specialize in scenario planning, critical path analysis, and portfolio-level impact assessments that support milestone delivery and enterprise prioritization. Core focus areas: Portfolio & project planning · Scenario planning & critical path analysis · Resource & capacity management · Governance & executive reporting · Cross-functional R&D collaboration
- Responsible for coordinating, monitoring, and reporting project schedule and resource management information to enable alignment of GPD and partner line schedules and FTE/dollar resources - Identifies and raises schedule conflicts, risks, and resource peaks/troughs appropriately for resolution - Directly participates in and contributes to cross-functional and functional teams to discuss, review, and optimize protocol/project/program schedules and study cost estimates and resource management plans - Monitors progress of project activities towards next project milestone, anticipates and highlights potential variances, supports line/team in critical path analyses and understanding the impact, and partners with the Asset PM, Clinical Operations, and the project team to identify/recommend solutions to schedule risk - Performs scenario planning of project timelines within and across protocols and across therapeutic area/portfolio to enable optimum use of local, global, and outsourced resources to ensure efficient delivery of project milestones - Partners with key team members (e.g., PPM, Medicinal Sciences, CS&O, DSRD, Commercial) to manage the project and achieve key milestones according to the endorsed timeline, cost, and quality parameters - Supports negotiations in the allocation of line resources to support the endorsed development plan - Contributes to risk management through the identification of operational and project/program risks for discussion with appropriate team leadership - Provides the Portfolio Management group with project schedule information to enable effective portfolio management activities - Produces what-if scenario analyses (base, optimistic and pessimistic development) based on context obtained from project team members - Provides timely reporting to the Asset PM, Portfolio Management, and project teams, alerting them to the possibility of endangered/missed or conflicting milestones and critical path activities
- Was accountable for detailed clinical trial execution plans (phase I-IV) for Global Development Operations (GDO) starting with portfolio and asset governance support and managed through CSR finalization - Provided critical path analyses to drive optimization of trial planning, country allocation & feasibility, and assessment of risks to trial delivery - Partnered within the Study Management Team to monitor delivery of clinical study milestones - Identified gaps and risks in the study plans and collaborated to proactively develop solutions which increased efficiency and minimized timelines - Monitored overall study health and ensured risks and issues were evaluated and appropriately captured in systems and tools, as needed - Captured risks, mitigations, resolutions, and escalations of issues and status - Provided regular study status reports to key GCO, Study Team, and governance stakeholders consistent with established processes and best practices - Demonstrated a strong understanding of the overall project goals, the indication studied, and the purpose of the assigned study in meeting the objectives of the project
- Was responsible for reviewing/management of the Trial Master File (TMF) for completeness and timely follow-up with the document owners and cross-functional team to drive TMF content provision - Supported running GCDO dashboards and metrics reports with the option to provide status analysis - Delivered an overview of data management metrics consisting of data entry/missing pages, source data verification progress, and query resolution - Maintained key trial specific information, such as trial contacts and distribution lists - Provided knowledge and expertise as a subject matter expert (SME) - Set-up study specific training curriculum and followed-up on training completion - Oversaw task delegation of central team members assigned to studies - Assisted in ancillary supply management, including ordering, distribution, and tracking - Ensured the current study status and tracking of trial related information was available at all times in the appropriate CTMS - Coordinated and participated in internal and external study specific meetings and documented any actions, decisions, and issues
- Coordinated distribution, retrieval, quality check and tracking of regulatory documents required for clinical trials in accordance with ICH/GCP guidelines and company mandated SOPs - Acted as a main contact for investigative sites regarding study procedures, tools, supplies, payments, etc. - Performed quarterly internal review of the eTMF for accuracy and completeness - Responsible for archiving of site and general study files - Processed patient payments grant requests, maintained payment database, generated status reports and resolved inquiries for the investigative sites pertaining to payments - Liaised with Legal Department to initiate and processed clinical trial agreement amendments - Responsible for training/mentoring new colleagues on SOPs and tasks associated with the position - Organized teleconferences between investigator sites and study team - Processed and tracked shipment requests for Investigational Product supplies - Acted as main point of contact for the central IRB being utilized for the study - Created and maintained multiple databases for appropriate study administration
- Planned, coordinated, and led site start-up activities, including initiating site training and tracking site shipments - Responded to site inquires and resolved data queries, such as missing data or incomplete paperwork - Generated, reviewed, and distributed weekly/monthly project tracking reports - Entered and maintained collected imaging data into internal software as well as online portal databases - Created meeting agendas for teleconference calls, provided study specific metrics, and recorded meeting minutes