Therapeutic Area Project Lead
Il y a 5 mois
Location:
Antwerp, Belgium
- Contact:
Amandine Planche
- Job type:
Permanent
- Contact phone:
+32 10 68 53 34
- Industry:
Pharmaceutical, Life Sciences, Clinical Research
The Therapeutic Area Project Lead is responsible for seamless fully integrated E2E support at various levels for CPP (Clinical Pharmacology & Phamacometrics) Programs across therapeutic areas, in alignment with compound development strategy.
**Responsibilities**
- Provide oversight to outsourced CPP deliverables and ensure that all activities are in compliance with CPP strategy, regulatory and legal requirements and with company SOPs.
- Serve as a CPP departmental liaison for outsourcing and contribute to the implementation and execution of the sourcing strategy.
- Work closely together with CPP Leaders and Pharmacometrics Leaders (PMLs) within CPP.
- Lead business process improvement initiatives to contribute to the efficiency and effectiveness of the CPP organization.
- Proactive planning, timeline management and follow-up of specific CPP outsourced deliverables on a trial level (examples: synopsis development, protocol development, pharmacokinetic/pharmacodynamic parameters analyses and reporting, etc) and/or compound level (examples: health authority requests, submission documents, etc).
- Ensure CPP outsourced 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, regarding CPP outsourced deliverables.
- Coordinate and track pre
- and post
- CPP 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.
- Assist CPP Therapeutic Area (TA) Group leaders and Pharmacometrics Group Leaders to manage the portfolio from a resource, planning and budget perspective in alignment with Project Management Office (PMO) Lead and compound development strategy.
- Facilitate communications within CPP and between/across functions, related to planning, submissions, cost estimation, outsourcing, quarterly FTE/OOPs review/validation for financial planning, by compound.
- Closely follow up on timely execution and finalization of contracts/work orders with External Service Provider (ESPs)/vendors, in partnership with Client R&D Procurement.
**Requirements**:
- B.S., M.S., PharmD or equivalent with 3 years of pharmaceutical company/CRO experience, including project management, in early development trials with PK, is required.
- Experience in immunology/oncology
- Understanding of scientific operations associated with clinical pharmacology, clinical drug development, and overall pharmaceutical R&D process is required.
- Fluency in English
- Ability to critically analyse problems and provide creative solutions is required.
- Discipline and confidence to work in teams and to work independently is required.
- Ability to effectively manage multiple tasks and projects with accelerated timelines is required.
- Ability to communicate, verbally and in writing, to individuals and groups at various levels in the organization is required.
- Experience working with teams across global time zones is required.
- Existing right to work in Europe required
**Benefits**
- Full-time position
- Balance between remote/office work : 1-2 days on site
- Balanced salary package
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