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The Clinical Pharmacology & Pharmacometrics (CPP) Therapeutic Area Project Lead role is responsible for seamless fully integrated E2E support at various levels for CPP Programs (portfolio, study, program, submission level) in alignment with compound development strategy.
If you have affinity with a pharma context and you're fluent in English. Please send me your resume.
email@example.com or call me on 03 200 28 01.
Are you interested in a Clinical Research position within the pharma industry and you like to work in Beerse? Please keep on reading because this could be your new job opportunity!
Assist CPP Therapeuthic Area (TA) Group leaders and Pharmacometrics Group Leaders with portfolio management meetings to plan and manage the portfolio from a resource, planning and budget perspective in alignment with Project Management Office (PMO) Lead and compound development strategy.
Establish timelines to support compound development plans, consistent with overall business plan and CP strategy in collaboration with Project Management Office personnel, finance, Global Clinical Development Operations Organization (GCDO), CPP Leader, Pharmacometrics Leaders and other business partners.
Represent CPP in cross-functional working groups per compound, and other non-trial-specific project-related meetings, to provide input regarding project or submission deliverables.
Management of Clinical Pharmacology (early development: Mainly Phase I) trials. Take a lead in the planning and outsourcing of Clinical Pharmacology deliverables (Synopsys, Protocol, Pharmacokinetic/Pharmacodynamic parameters, reporting) within different therapeutic areas.
Assure that timelines are met and follow up on changes in scope, timelines, budget and Quality and report to the relevant parties.
This role requires a working experience with SharePoint, Excel, and an in-depth knowledge of contracting processes and systems, as well as compliance requirements for paying of vendors engaged in clinical research activities.
Closely follow up on timely execution and finalization of contracts/work orders with External Service Provider (ESPs)/vendors, in partnership with Janssen R&D Procurement.
Provide External Service Provider (ESP) management.
Carry out functional responsibilities in accordance to applicable SOPs and Regulatory requirements.
B.S., M.S. or equivalent with 4 years of industrial experience or CRO experience in areas of Drug Development is required.
Project management experience (early development trials with PK) is required.
Working knowledge of functional planning systems, tools and OOPs algorithms is preferred.
Experience with SharePoint, Excel and ARIBA is preferred.
Understanding of scientific operations associated with clinical pharmacology, clinical drug development, and overall pharmaceutical R&D process is required.
Knowledge of clinical pharmacology/pharmacokinetics concepts is preferred.
what do we offer?
As an answer to your high performance & flexibility, AUSY offers you an interesting salary package, with some interesting extra's like:
Meal vouchers of €7
Net representation cost of €50
Car + unlimited fuel card OR home-work compensation