Preclinical Project Manager

Preclinical Project Manager

The Project Management Office (PMO) is part of the Janssen R&D organization. Their mission is to bring the right products to patients by driving R&D Programs and portfolio decisions through integrated time, scope risk, resources and people management.
Within Discovery Sciences, PD&S is responsible for the assessment of the preclinical safety profile of internally and externally generated small molecules (and vaccines) starting in the discovery phase up to post-approval support. Among the major, critical capabilities are integrated drug development support and global submissions, pharmacokinetics, dynamics and metabolism, bio-analysis, isotope synthesis, PK/PD modeling, toxicology/pathology, mechanistic and investigative safety and laboratory animal medicine support.

The Senior Manager, PD&S Project Manager provides project management support to Pre-Clinical Development (PCD) Leaders and PCD teams. This includes:

• **building project timelines
• developing and analyzing scenarios, risk assessment and mitigation planning
• developing project budgets
• developing resource needs (FTE’s = Full Time Equivalents) with PD&S functions

•** tracking and reporting actualization of project timelines, budgets and FTE’s.
The Senior Manager, PD&S Project Manager provides support for continuous forecasting, quarterly financial updates, development of Business Plan Budgets and FTE’s and preparation for Governance Meetings. He/she is a member of the PD&S team (sub team of Compound Development Team) and works with the team and with PD&S functions to facilitate successful project execution, achievement of key deliverables and of budget and FTE goals. As a member of the Project Management Team he/she supports cross-functional planning, budgeting and resourcing activities.
The primary responsibilities include:

• be an active member of assigned PD&S Teams
• build and maintain project plans
• Develop forecasts regarding project resource needs (OOP’s and FTE’s)
• Track actual expenses and FTE’s against forecasts
• Liaise with project finance, program management and customer groups from Janssen R&D organization.

Qualifications Education :

• Bachelors Degree in Scientific Discipline (A Master’s Degree is highly preferred).

Experience :

• Minimum of 6-8 years experience in the pharmaceutical industry. • Knowledge of Pharmaceutical Development and Clinical Development. • Experience in Project Management. • Capability in the Microsoft suite of business software including MS Project, Visio and Excel. • Experience in working in multinational/multicultural organizations. • Prior Pre-Clinical Development / PD&S experience (preferably minimum of 2 years) • Knowledge of project management tools and techniques. Prior experience with Planisware is desirable Critical Competencies • Communication • Customer focus • Collaboration and teaming • Be able to work in a highly matrixed organization • Results and performance driven

RESPONSIBILITIES:

• Candidates will work with fellow scientists to designing and executing experiments including small-scale studies, and pilot plant and manufacturing studies in a variety of types and scales of equipment from bench top to pilot-scale, and, as required, technology transfer and validation in commercial plants.

• Based on the analyses of these studies, these positions will be expected to develop and test new hypotheses to improve fundamental understanding of the chemical and biochemical processes, including bio-conjugation or large and small molecule combinations.

• This position will support process validation, quality by design, regulatory approaches, and quality systems

• This position requires a highly motivated individual with the ability to work closely with other members of the laboratory and the department in a matrix environment.

• This position will also collaborate with the pilot plan and manufacturing staff on experimental studies, clinical manufacturing, and process validation, including work with external contract manufacturing organizations