Crucell is a global biotech company that focuses on the development, pro­duction and marketing of vaccines, recombinant proteins and antibodies to prevent and combat infectious and other diseases.

Within Crucell talented, entrepreneurial people are working in a dynamic cul­ture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Crucell.

Program Director

Job Description:
Areas of full responsibility
· Overall responsibility for development of assigned product(s).
· Design, planning, management and execution of approved product development/drug development programs.
· Operational and strategic decisions within program.
· Budget control.
· Full accountability for management of co-development programs with partners where applicable.
· Supervision and performance evaluation of project manager where applicable.

Areas of Support
· Provide input to development strategy of other PDG and I&DL programs.

Activities
Design, manage and execute PDG projects
· Define overall project strategy.
· Agree strategies for (Pre)Clinical, Manufacturing and Regulatory Affairs with line management.
· Negotiate and agree milestones & deliverables with line management in paritcular Regulatory Affairs, Clinical & Medical Affairs and Process Development
· Determine risks associated with achieving milestones and deliverables, implement and maintain risk mitigation plans.
· Design, planning, budgeting and execution of development plan.
· Trouble shooting.
· Act as the key liaison with partners in co-development programs.
· Facilitate and chair strategic project team meetings.
· Supervision of operational project team meetings.
· Supervision of generation and management of project file.
· Support Regulatory Affairs in the generation of documentation for regulatory filing.
· Program reporting to management.
· Keep up to date with knowledge relevant to the project(s), become the product specific champion within the company.

Minimum Qualifications:
· PhD or equivalent level.
· Minimally 10 years experience in relevant pharmaceutical and/or biotech company environment.
· Experience with late phase product development and GMP manufacturing.

Competences:
· Proven scientific and development skills (knowledge, accuracy, autonomy etc).
· Strong management skills.
· Development rather than research mindset.