Clinical Research Manager - Belgium The Clinical Pharmacology & Pharmacometrics (CPPM) Therapeutic Area Project Lead role is responsible for seamless fully integrated E2E support at various levels for CPPM Programs (portfolio, study, program, submission level) in alignment with compound dev
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The Clinical Pharmacology & Pharmacometrics (CPPM) Therapeutic Area Project Lead role is responsible for seamless fully integrated E2E support at various levels for CPPM Programs (portfolio, study, program, submission level) in alignment with compound development strategy.
- Providing oversight to all outsourced CPPM deliverables and ensures that all activities (in-house/outsourced) of CPPM are in compliance with CPPM strategy, regulatory and legal requirements and with company SOPs.
- Serve as a go to person for outsourcing within CPPM and contributes to the implementing and execution of the sourcing strategy.
- Work closely together with CPPM leaders, CPPM scientists and Pharmacometrics Leaders (PMLs) within CPPM.
- Leads business process improvement initiatives to contribute to the efficiency and effectiveness of the CPPM organization.
Main Accountabilities :
• Assist CPPM Therapeuthic 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.
• Maintain functional planning systems and faciliate communications within CPPM 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- CPPM 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.
• 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), CPPM Leader, Pharmacometrics Leaders and other business partners.
• Represent CPPM in cross-functional working groups per compound, and other non-trial-specific project-related meetings, to provide input regarding project or submission deliverables.
• This role requires a working knowledge of functional planning systems, tools and OOPs algorithms. Also requires experience with SharePoint, Excel, ARIBA, and an in-depth knowledge of contracting processes and systems, as well as compliance requirements for paying of vendors engaged in clinical research activities.
• Serve as the point person for all sourcing related activties within CPPM.
• 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.
• Lead training initiatives for external service providers/vendors.
• Provide leadership and direction in developing, improving and implementing processes and tools to enhance the efficient implementation of outsourcing strategy.
• Provide External Service Provider (ESP) management.
• Collaborate with Bioresearch Quality & Compliance (BRQC) department in support of proces audits related to sourcing and vendor audits.
• Participate in initiatives and working groups related to Outsourcing.
• Coordinate OOPs estimates for business planning.
• Drive and facilitate process development and improvement initiatives (with ESPs). Conduct lessons learned.
• Carry out functional responsibilities in accordance to applicable SOPs and Regulatory requirements.
• Participate in optimization/maintenance of planning systems and tools.
Work from home: Not Allowed
International Travel: Yes
No. of Positions: 1
Skills and Expertise
Desired Skills & Experience
Minimum Qualifications / Experience
• 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 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.
Estimated travel of up to 5% travel will be required, both domestic and international.