MISSION:
- the Project Manager (PM) will lead one or more Innovation & Development projects for one or more Pharmaceutical Product candidates and will coordinate multidisciplinary teams (internal & external) with a view to obtaining worldwide registration of the product.
- He/she will work in accordance with ethical rules, applicable US/EU regulations, good laboratory (GLP), manufacturing (GMP) and clinical (GCP) practices and health & safety rules.
- He/she will be part of the Innovation and Development department (I&D) and will report to the Project Director. He/she will be called upon to work in collaboration with the regulatory and quality teams in the company or the Group in connection with the project(s).
ACTIVITIES :
- Define the project(s) scope with internal or external subject matter experts / KOL
- Elaborate the feasibility and timelines
- Prepare and validate study and test protocols with regulatory affairs
- Identify and select the Vendors / CROs / Services Providers
- Define, monitor and present budget information including comparison with actuals
- Develop and present the project(s) internally and externally
PROJECT MANAGEMENT:
- Coordination, animation and management (internal and external multidisciplinary teams);
- Planning, monitoring and control, key performance indicators,
- Follow-up of professional relations with KOLs and Experts,
- Management and challenging of CROs, Consultants or Partners,
- Assessment of risks / potential problems and proposal of risk mitigation plan
KEY SKILLS:
- Has strong experience in management of the operations linked to pre-clinical or clinical development
- Can be involved in the development plan strategy for the product
- Has in depth knowledge of the constraints of the pharmaceutical sector (regulatory, quality, intellectual property).
- Proactive, he/she can act in autonomy
- Hands-on spirit, facilitator and solution-oriented mindset
- Able to identify, select, contract and manage partners
- Able to manage cross-functional projects and teams
- Fluent in writing and speaking English (Dutch is optional)
- Efficient and smooth communication orally and in writing
- Curious, agile and happy to be involved in a start-up type organization, where clinical development organization, procedures and tools need to be set-up.
EDUCATION/ RECOMMENDED TRAINING:
- Scientific background (at least Master degree) ideally in Health care sector
- Additional experience in finance and planning would be welcome
- Fluent in Project Management tools and MS Office package
- 10 years of experience in clinical or pre-clinical Project Management (ideally in sterile or ophthalmology products)