In this role you will be providing oversight to all outsourced CPP deliverables and ensure that all activities (in-house/outsourced) of CPP are in compliance with CPP strategy, regulatory and legal requirements and with company SOPs. You work closely together with CPP leaders, CPP scientists and Pharmacometrics Leaders (PMLs) within CPP.
- Assist CPP Therapeutic 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., PharmD 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.
- Experience 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.