Clinical Pharmacology Project Lead - 100% Remote

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.

Objective of Position

The Clinical Pharmacology and 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.

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.

Main Accountabilities

• Active participation in cross-functional meetings and other meetings, as needed, regarding CPP outsourced deliverables.
• Closely follow up on timely execution and finalization of contracts/work orders with External Service Provider (ESPs)/vendors, in partnership with ClientR&D Procurement.
• 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).
• Effectively communicate changes in scope, timelines and budget to key stakeholders.
• 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.
• 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.
• Ensure CPP outsourced project deliverables meet and exceed expectations, are provided timely and with high quality.

Minimum Qualifications / Experience

• Ability to communicate, verbally and in writing, to individuals and groups at various levels in the organization is required.
• Discipline and confidence to work in teams and to work independently is required.
• Experience working with teams across global time zones is required.
• 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 working with External Service Providers is preferred.
• Ability to critically analyze problems and provide creative solutions is required.
• Knowledge of contracting processes and systems, as well as compliance requirements for paying of vendors engaged in clinical research activities, is required.
• Understanding of scientific operations associated with clinical pharmacology, clinical drug development, and overall pharmaceutical RND process is required.
• Sound knowledge of pharmacokinetic and pharmacodynamic concepts, including noncompartmental analyses, is preferred.
• Ability to effectively manage multiple tasks and projects with accelerated timelines is required.
• Experience with SharePoint, Excel, Microsoft Teams and OneNote is preferred.