Direct accountability and responsibility of multiple global Clinical Development Programs in various therapeutic areas (Cardiovascular/Metabolic, Neuroscience, General Medicine) across 24 countries and up to 250 sites in all geographic regions.  Direct responsibility for provision of client deliverables on-time, within budget and scope and with required quality for assigned projects or programs. Led cross-functional teams and managed up to 50 project team members, including both internal and external ancillary services and vendors. Contribute to proposal strategy, development, costing, and bid defence for assigned business development opportunities. Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects or programs. Ensured that all staff allocated to assigned projects or programs adhere to professional standards and SOPs as well as scope, quality and budget. Define and manage project or program resource needs and establish succession plans for key resources including employee recognition and mentorship. Proactively develop strategies to minimize write-off and identify out of scope activities, execute necessary change orders and support negotiations with client on project budget issues. Monitor and control the risk plan/register and provide ongoing oversight to ensure mitigation plans are in place and working. Escalate risks newly identified by the project team to stakeholders. Led inspection readiness initiatives for multiple studies in registration phase. Lead core project team and facilitate team’s ability to lead extended/complete project cross-functional team.

Led global program team and facilitate team’s ability to lead extended/complete program team in Neuroscience and Cardiovascular/Metabolic Therapeutic Areas. Ensured effective cross-functional teamwork among program team members including both internal and external ancillary services.  Served as escalation point for project issues, resolving conflicts as needed. Managed project schedule and scope to ensure both remain on track. Proactively engaged in both quality assurance and risk management activities to ensure project deliverables are met according to both internal and external requirements. Accountable for budget and invoicing across assigned project(s) including the control and minimizing write-off.  Met financial performance targets for the assigned projects and proactively managed change control processes both internally and externally, including execution of necessary change orders. Initiated improvements to enhance the efficiency and the quality of the work performed on assigned projects. Define and manage project resource needs and establish succession plans for key resources. Responsible for appropriate issue escalation to appropriate stakeholder(s).

Independently manage operational execution for Phase I to Phase IV global clinical study programs in Cardiovascular, Neuroscience and Hormone Therapeutic Areas and the Clinical Pharmacology group. Serve as key point of contact for all external contractors, including Contract Research Organizations (CROs) conducting clinical trials, including alliance partnerships.  Ensure adherence to timely study deliverables, maintenance of budgets, as well as quality and contractual compliance with clinical sites and external vendors.  Manage 4-6 clinical trials simultaneously, in different phases and consisting of differing complexity and size (some trials recruiting hundreds of participants, running several years in multiple countries).  Coordinate all aspects of study startup; meet with as many has several hundred assigned research managers including Doctors, Clinic Administrators and CRO Managers to discuss details of protocol, structure/design of study, potential issues with patients and their recruitment. Oversee processes and deliverables of CROs to review results and final report.

Worked in The Netherlands as Global head of Clinical Supplies Management Office. Functional oversight of seven direct reports in the Netherlands office and two reports in the US office. Coordinated the supervision of over 120 ongoing clinical trials, providing supplies for any drug trial in operation across the organization for all Phase studies. Ensured all customers and support departments were in constant communication. Functioned as primary contact for all external contractors used in clinical supply preparation and management.  Coordinated logistics for all trials:- determined supply strategy for predetermined number and locations of trial and participants- arranged for distribution and delivery of supplies and pharmaceuticals- oversaw development of manufacturing, packaging and sourcing of study medication and ancillary supplies- Maintained accountability for initial shipment of drugs, re-supply and destruction after each phase of trial, including import/export logistics.  Drafted and published detailed procedures for implementation of trials globally and throughout company, including procedures for randomizing and un-blinding the study when required. Developed corporate process for management of clinical supply system; participated in group to integrate corporate systems.

Management and training of direct report to assist in Clinical Supplies functions. Management and transfer of Clinical Supply functions from an acquired company to the Solvay Clinical Supplies group. Continued management of Clinical Supplies activities in correlation with Clinical Supplies Coordinator.

Management of Clinical Supplies activities for all Phase I-IV clinical studies conducted in the US, consisting of approximately 50 ongoing studies covering over 20 products. Coordination with Clinical Operations personnel and outside vendors to meet clinical supply demands for studies. Drafting and implementing standard operating procedures governing clinical supply processes and alert/alarm procedures for investigational products. Management of clinical reserve sample inventory and storage area.

Drafting standard operating procedures for department, including procedures governing warehouse management, inventory control, reserve samples inventory, sampling and weighing operations, retesting of materials. Training employees on proper procedures. Management of the R&D facilities warehouse. Inventory control and documentation of all products from receipt at the facility to destruction.

Pre-Clinical Research and Development ArchiveResponsibilities include documentation and registration of information provided by all departments of Pre-Clinical Research and Development. Pulling information for review by FDA auditors and consultants as needed. Directly report to documentation manager. Responsible for training other temporary employees in department.