R&D Program Management Director
Our client, a biopharma start up at a very exciting stage are currently recruiting for an R&D Program Management Director to join their team on a permanent basis. As R&D Program Management Director you will be responsible for the coordination and program management of all non-clinical, clinical, CMC, device development and regulatory activities related to the research and development program for a novel inhalation combination product for treatment of neurological conditions. In this role, you will work closely with all functions to build, maintain and deliver upon the development program through implementation and application of project management principles.

Responsibilities

• Coordinate a cross functional team in the implementation of a complex combination product development program and the associated non-clinical, clinical activities and regulatory interactions
• Prepare project objectives that support the corporate objectives and organize cross functional activities to ensure completion of the project within scope, on schedule and within budget constraints
• Develop and manage program plans and budgets in conjunction with functional leads and senior management
• Manage program risks and issues, evaluate contingency plans and risk mitigation activities, while ensuring effective communication with senior management
• Guide cross functional team in resolving conflicts and indecisions, regularly and effectively
• Implement and champion PM best practises for application across the organisation
• Through collaboration with the Finance department, define budget requirements and report quarterly actuals per financial schedule

• Master’s degree in a relevant scientific discipline required
• Experience with project management methodologies (e.g. Prince 2 / PMP)
• Strong understanding of ISO 13485 and FDA regulations preferred
• Minimum 8 years of experience in R&D preferably within a project management role
• Strong communication and stakeholder management skills, with an ability to influence the direction and strategy of a complex cross functional development program