Job description
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.
Responsibilities
- 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.
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.