Define the strategic clinical development plan in line with the global R&D strategy, the specific Franchise (commercial) strategy and the Regulatory needs.
Present, defend and get endorsement of the clinical strategic plan with the appropriate governance committees within the company.
Support the different functions within the Clinical Team with his/her expertise and leadership (monitoring, data management, biostatistics, medical writing, pharmacovigilance, regulatory affairs) as well as interact with and support Project team members, Clinical Immunology Laboratory, Budget and Planning Functions, Legal and Patent Department, Product Brand Leader and Medical Affairs.
Ensure that the operational development process is aligned with the company Standard Operation Procedures (SOPs), and help to review and improve current SOPs.
Manage the clinical development process from early stage development until licensure and provide clinical leadership for the generation of evidence from the clinical development data that will support the licensure and commercialization of the new vaccines (e.g. define evidence generation plan, lead interpretation of clinical data, provide decision-making pathways based on study outcomes, provide risk management analyses and mitigation plans etc) .
Work closely with the pharmacovigilance department to define and ensure the process of safety surveillance during clinical development and design the safety risk management plan.
Preferred: M.D. with relevant experience or specialization in line with the company’s portfolio (Infectious Diseases / Preventive Vaccines), or PhD with a minimum of 3 years’ experience in Clinical Development of Vaccines (Infectious Diseases).
A background in clinical immunology is welcome
Experience with working according to GCP/ICH guidelines
Excellent interpersonal skills, experience with leading and managing transversal teams
Ability to work in a diverse environment with different stakeholders
Considerable degree of autonomy
Ability to act for change, empower themselves and others.
Good command of oral and written English.
Take the lead for the preparation of key clinical documents to be prepared for clinical trials (protocols, reports), CTD submissions, interactions with the company governance bodies, external experts and committees.
Build and maintain a strong network of internal and external collaborators, opinion leaders, investigators and competent authorities.
Support the Global Clinical Sciences department with non-project related activities to continuously improve our way of working, and to maintain our position as center of clinical excellence of the company and with external collaborators.