Quantitative Clinical Pharmacology (QCP) Project Leader
The QCP Project Lead role is responsible for seamless fully integrated support at various levels for QCP Programs across therapeutic areas.
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The QCP Project Lead role is responsible for seamless fully integrated support at various levels for QCP Programs across therapeutic areas.
Your responsibilities and your Impact:
- Serve as a QCP departmental liaison for client meetings
- Work closely together with QCP Leaders within QCP.
- Lead business process improvement initiatives to contribute to the efficiency and effectiveness of the QCP organization.
- Help guide and deliver MIDD strategy and components across multiple clients, modalities and indications.
- Help inform and guide stakeholders in clinical pharmacology strategies.
- Be an essential part in a dynamic and motivated group by encouraging and mentoring junior modelers.
Key Job Activities:
- Proactive planning, timeline management and follow-up of specific QCP deliverables (examples: synopsis development, protocol development, pharmacokinetic/pharmacodynamic parameters analyses and reporting).
- Ensure project deliverables meet and exceed expectations, are provided timely and with high quality.
- Effectively communicate changes in scope, timelines and budget to key stakeholders.
- Active participation in cross-functional meetings and other meetings, as needed.
- Assist Pharmacometrics Leaders to manage the portfolio from a resource, planning and budget perspective in alignment with Project Management.
Education and Experience Required for Role
- Bachelor, Master, PhD or equivalent with 5 years of pharmaceutical company/CRO experience, including project management, in early development trials with PK, is required.
- Understanding of scientific operations associated with clinical pharmacology, clinical drug development, and overall pharmaceutical R&D process is required.
- Discipline and confidence to work in teams and to work independently.
- Ability to effectively manage multiple tasks and projects with accelerated timelines.
- Ability to communicate, verbally and in writing, to individuals and groups at various levels in the organization is required.
- Working with teams across global time zones is required.
- Sound knowledge of pharmacokinetic and pharmacodynamic concepts, including nonlinear mixed effects modeling and MIDD, is essential.
- Working expertise of NonMem and PopPK modeling essential. MatLab and WinNonLin proficiency a plus.
Location: Remote/Hasselt, Belgium
Position Type: Full-Time
Apply today!
