Director, Clinical Project Management

Director, Clinical Project Management

The Director, Clinical Project Management will manage assigned project(s), including program’s strategic direction, integrated project plan, alliance management, cross-functional deliverables as required by the International Project Team. This role requires interaction with, and management of, internal cross-functional team members, business partners, and contractors.

Responsibilities

• Oversees the development of compounds from candidate selection to NDA/MAA filing for the assigned project(s) in the Neurology or Oncology Business Group, in accordance with agreed to development plans and corporate objectives.
• Advanced understanding of clinical research and the clinical drug development process
• Advanced understanding of the Neurology or Oncology therapeutic areas
• Advanced understanding of the drug development plans, preclinical toxicology, toxicology, CMC, regulatory and other development requirements as they relate to efficient execution of the development plans.
• Advanced understanding of clinical trial management, including general understanding of all specialized support functions.
• Budget management
• Ability to effectively prioritize work and engage in creative problem solving to manage global projects.
• Proactively identify, analyze and resolve project issues to ensure project milestones are met and projects are completed, with quality, on time and within budget.
• Ability to work independently, with strong organizational, communication and interpersonal skills (works well with all levels of staff in a professional manner)
• History of working in complex team environments with numerous and diverse key stakeholders in multiple regions

Qualifications

• Bachelor’s degree is required; advanced degree preferred (MS or PhD); PMP preferred
• Minimum of 12+ years’ experience in clinical project management; deploying project management methods; influencing work processes that span across departments and geographic boundaries.
• Effective leadership and participation in global initiatives.