Therapeutic Area Project Lead

For a global pharmaceutical company in the area of Antwerp, we are looking for a Clinical Pharmacology & Pharmacometrics (CPPM) Therapeutic Area Project Lead. 

  • Do you have Project Management experience?
  • Do you have experience with managing cross-functional teams?
  • Do you know how to work with external service providers?
  • Are you ready to start a very interesting challenge in a leading company?

Then don't hesitate to apply!

Job Description 
  • You provide oversight to all outsourced CPPM deliverables and ensure that all activities (in-house/outsourced) of CPPM are in compliance with the CPPM strategy, regulatory and legal requirements and with company SOPs. 
  • You serve as a go to person for outsourcing within CPPM and contribute to the implementation and execution of the sourcing strategy. 
  • You work closely together with CPPM leaders, CPPM scientists and Pharmacometrics Leaders (PMLs) within CPPM. 
  • You leads business process improvement initiatives to contribute to the efficiency and effectiveness of the CPPM organization. 
Responsibilities 

In this role you are responsible for seamless fully integrated E2E support - at various levels - for Clinical Pharmacology & Pharmacometrics Programs (portfolio, study, program, submission level).  This in alignment with the compound development strategy. 

  • Assist CPPM 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. 
  • Maintain functional planning systems and faciliate communications within CPPM and between/across functions, related to planning, submissions, cost estimation, outsourcing, quarterly FTE/OOPs review/validation for financial planning, by compound. 
  • Coordinate and track pre- and post- CPPM submission related activities/deliverables across all TAs for one or more products in late development and established products ensuring alignment with, and delivery on, the compound submission plan. 
  • 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), CPPM Leader, Pharmacometrics Leaders and other business partners. 
  • Represent CPPM in cross-functional working groups per compound, and other non-trial-specific project-related meetings, to provide input regarding project or submission deliverables. 
  • This role requires a working knowledge of functional planning systems, tools and OOPs algorithms. Also requires experience with SharePoint, Excel, ARIBA, and an in-depth knowledge of contracting processes and systems, as well as compliance requirements for paying of vendors engaged in clinical research activities. 
  • Serve as the point person for all sourcing related activities within CPPM. 
  • Closely follow up on timely execution and finalization of contracts/work orders with External Service Provider (ESPs)/vendors, in partnership with Procurement. 
  • Lead training initiatives for external service providers/vendors. 
  • Provide leadership and direction in developing, improving and implementing processes and tools to enhance the efficient implementation of outsourcing strategy. 
  • Provide External Service Provider (ESP) management. 
  • Collaborate with Bioresearch Quality & Compliance (BRQC) department in support of proces audits related to sourcing and vendor audits. 
  • Participate in initiatives and working groups related to Outsourcing. 
  • Coordinate OOPs estimates for business planning. 
  • Drive and facilitate process development and improvement initiatives (with ESPs). Conduct lessons learned. 
  • Carry out functional responsibilities in accordance to applicable SOPs and Regulatory requirements. 
  • Participate in optimization/maintenance of planning systems and tools. 
Profile 
  • You have a bachelor, master, phd or equivalent with 4 years of industrial experience or CRO experience in areas of Drug Development. 
  • Project management experience is required. 
  • Experience with managing cross-functional teams is required. 
  • Experience working with External Service Providers is preferred. 
  • Working knowledge of functional planning systems, tools and OOPs algorithms is preferred. 
  • Experience with SharePoint, Excel and ARIBA is preferred. 
  • Ability to communicate effectively, verbally and in writing, to individuals and groups at various levels in the organization is required. 
  • 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. 
  • Experience working with off shore teams across global time zones is required.
Contact Information 

Nele Daems
(015 21 11 04)
nele.daems@valesta.com

 

Application form : Therapeutic Area Project Lead

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