Marleen Hereygers, Phd Email & Phone Number

Antwerp, Be

Ghent, Flemish Region, Belgium

2 Bridge is a Belgian based company that provides scientific support, project leadership and due diligence services for pharmaceutical and health product development and production. For more information: www.2bridge.be

Beerse, Flemish Region, Belgium

As a core member of the Compound Development Team (CDT), I provided program management and cross-functional operational leadership for the development of therapeutic products in a global, matrix organization. Established CDT strategy in partnership with the CDTL, with goals and objectives that are aligned with organizational objectives; contributed to and coordinated compound strategy updates over time and provided context and history to new team members. Mentored colleagues in team best practices. Led the team to translate CDT strategy into an integrated, executable plan. Partnered with cross functional leads at the program level to assure end to end program oversight; and to identify and mitigate risks and issues to maintain quality, timelines, resources and budget. Took a lead role in ensuring cross-functional readiness for stage gate reviews and governance reviews and decisions. I motivated colleagues through personal example, and dedication to team goals. Inspired confidence and build group trust. Provided positive and constructive feedback in the moment. Demonstrated ability to resolve conflict and influenced teams without formal authority. Contributed to the success of the PMO in achieving its goals and objectives by ensuring program work is conducted in compliance with PMO processes and Company policies. I was awarded by the J&J team for my strong organizational and leadership skills.

The role of the Senior Project Manager IVD is to lead, plan, execute and finalize IVD product development projects according to tight deadlines.• Direct and manage project lifecycle from beginning to end. • Conduct and lead product development projects and teams. • Define project scope, goals and deliverables that support business goals.• Develop project plans and associated communications documents. • Plan and track project timelines and milestones.• Estimate the resources and participants needed to achieve project goals. • Manage the project interfaces with the departments and internal teams.• Develop best practices and tools for project execution and management. • Develop and deliver progress reports, proposals and presentations. • Create budget proposals, and recommend subsequent budget changes where necessary.• Ensure quality and compliance throughout the project’s life cycle. • Manage the Design & Technology Transfer to Operations • Ensure product launch preparedness for all internal functional areas. • Coach, mentor, motivate and supervise project team members.

Supervising clinical trials and providing leadership in the delivery of service to clients. Overseeing the work done by the project management, monitoring and data management teams (> 35 staff) with direct and 2nd line management responsibility. Being responsible for establishing operating policies & procedures related to project management, worldwide.Member of the European Management Team : Metrics and Financials

Clinical Trial Leader and Global Trial Manager for compounds in development for HIV and Hep CInternational Operational Management Clinical Trials- Responsible for Phase III trials (TMC278, VX950)- Coaching for Phase III trials (TMC278, VX950)

Training Manager with experience in- line management- providing training to Project Managers and Monitors- organizing and giving ICH-GCP training- organizing all kinds of job-related training, soft skill training, languages training- developing workshops to train Monitors and Project Managers for the ACRP certification exam- developing an advanced clinical research course- developing a training database to evaluate training per person- selecting external parties- managing the training budget- the applicable guidelines regarding the conduct of a clinical trial- ICH-GCP helpdesk

As “Project Manager” experience in the following activities:- oct/2001 – 31/dec/2002: “Clinical Trial Leader” at Tibotec (phase I and II TMC125 compound)- line management- follow-up in US two internat. studies (HIV, VIRCO), in several sites spread over the US East coast- set-up and follow-up of an international study in CNS in Europe for an American Sponsor - responsible for internal/external communication- preparing study documents and reports - coaching of the study team- follow-up of study timelines- budget evaluation

Follow-up in Belgium of a national study (cardiology, phase III) in several centers Follow-up in the US of two international studies (HIV, VIRCO ), in several sites spread over the East US coast

As data reviewer, I was involved in the full scope of review activities related to Clinical Trials (o.a Loviride, Risperdal,...)

In parallel with my PhD, I provided laboratory sessions to students.