BE - Project Lead Clinical Pharmacology

The Clinical Pharmacology & Pharmacometrics (CPP) Project Lead role is responsible for seamless fully integrated E2E support at various levels for CPP Programs across therapeutic areas, in alignment with compound development strategy.

Your responsibilities and your Impact:

• 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.

Key Job Activities:

• 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 Janssen R&D Procurement.

Education and Experience Required for Role

Essential:

• Bachelor, Master, PhD or equivalent with 3 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.

• Ability to critically analyze problems and provide creative solutions.

• 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.

• Experience working with teams across global time zones is required.

• Knowledge of contracting processes and systems, as well as compliance requirements for paying of vendors engaged in clinical research activities.

• Sound knowledge of pharmacokinetic and pharmacodynamic concepts, including noncompartmental analyses, is preferred.

• Experience working with External Service Providers is preferred.

• Experience with SharePoint, Excel, Microsoft Teams and OneNote is preferred.

Things to remember before applying for this role:

• We do not accept applications via email.

If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 

Thank you very much and we look forward to receiving your application.

Questions

If you would like some additional information about the role please contact: bdardenn@its.jnj.com (please note that we do not accept applications via email).

Diversity, Equity & Inclusion:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Belgium are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.