Based in Belgium (Nivelles, Jumet or Brussels), you will join a fast-growing team full of passionate colleagues. You will help our experts find and access the information that is essential for state-of-the-art process and product development and fact-based decision-making.
Define, own, maintain and ensure implementation of the Product Development Plan for all vaccine development projects.
Lead the cross-functional vaccine development teams; accountable for project delivery in line with predefined objectives and constraints.
Attend Vaccine Management Team meetings for executive project review and strategic decision-making.
Lead the Product Development department within Univercells Vaccines.
- Define the strategic and tactical plan for all vaccine development projects within the company’s portfolio, in collaboration with the subject area team leaders and Project Management Office; includes identification of all required resources for successful project delivery (human, financial, infrastructure & equipment, external services, technologies etc.)
- Review and approve planning documents for vaccine development operations (all areas: drug substance and drug product development, analytical method development, clinical manufacturing and testing, nonclinical and clinical development, regulatory affairs etc.)
- Maintain the Product Development Plan (PDP) across the project lifecycle and ensure all related planning documents remain synchronized with the PDP
- Organize and lead regular cross-functional communication, including chairing of Vaccine Development Team and Vaccine Project Team meetings
- Provide development expertise and facilitate scientific, strategic and tactical decisions as required
- Supervise project delivery in accordance with approved planning documents and identify, escalate and solve / mitigate project issues and risks
- Ensure preparation of appropriate project status reports for discussion with the management team and other key stakeholders (internal / external); attend strategic and leadership meetings as required
- Identify and drive creation and implementation of new methodologies for improved execution of development projects (budget, time, quality…)
Product Development Leadership
Lead Product Development department within Univercells Vaccines, comprising Regulatory Affairs, Nonclinical development, Clinical Development and Medical Affairs:
- Recruitment, day-to-day supervision, coaching, development and performance review of Product Development (internal / external) staff
- Organizational planning and distribution of tasks within the remit of the department
- Creation, implementation and continual improvement of standard working practices, templates and tools
- Accountable for all deliverables produced within the Product Development department
- Accountable for department finance (budget planning and control)
- Represent department at Vaccine Management Team meetings
REQUIREMENTS / QUALIFICATIONS
- Master’s degree or PhD in life sciences
- At least 10 years of experience in the biopharmaceutical industry, including at least 5 years of experience in vaccine development; experience with global health vaccines is a plus
- Demonstrated working knowledge and deep understanding of all aspects of vaccine development, including pharmaceutical development (DS and DP, all areas), vaccine manufacturing and quality control, nonclinical and clinical development, and medical and regulatory affairs
- The ideal candidate has deep expertise in one field of vaccine development (field of excellence), preferably (non)clinical development or regulatory affairs
- Up-to-date knowledge of contemporary product development practices (e.g. QbD) and state-of-the-art vaccine manufacturing technologies
- Demonstrated strong leadership skills, both in a matrix environment (without direct managerial authority) and as a direct supervisor (line management responsibility)
- Excellent communication skills, both written and spoken
- Strong analytical and problem-solving skills
- Proven experience with management of several projects in parallel in high pressure circumstances
- Fluency in English (both written and oral) is mandatory; proficiency in French is a significant plus