We are seeking a highly motivated medical doctor to join the Global Clinical Development team of our company.
Within our company Research and Development, and more specifically the Global Clinical Development Department, and within the guidelines given by the Clinical Franchise Leader, the Global Clinical Development Expert (GCDE) is a key member of the Project Team and a leader of the Clinical Team. The R&D project team, plans, develops and manages the project strategy, in order to obtain registration of a new product or improvement of a vaccine for the prevention and / or treatment of the disease. The GCDE is responsible for the clinical development strategy and is thus a core member of the R&D Project team. The Clinical Team is responsible for the execution of the clinical development plan, specifically the clinical studies defined therein. The GCDE leads the Clinical Team, ensuring that the clinical development strategy is executed according to the adequate processes and with the highest clinical and medical scrutiny.
The candidate will report to the Clinical Franchise Leader for Meningococcal Vaccines and will be responsible for projects involving one or more meningococcal vaccines under development. However, at Global Clinical Development we work in a flexible model and the candidate’s responsibility could be extended to other vaccine areas within our company.
The candidate will have a medical degree. Pharmaceutical clinical development experience is preferred. Expertise in immunology, specifically in the clinical development of preventive vaccinology is favorable. The candidate should have excellent oral and written communication skills in English.
This exciting role will afford candidates the opportunity to be intimately involved in clinical strategy, and all stages of operational clinical development.
The candidate will be responsible to:
- 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 our 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 our company's 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.
- Take the lead for the preparation of key clinical documents in the context of clinical trials (protocols, reports), CTD submissions, interactions with our company's 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 Development department with non-project related activities to continuously improve our way of working, and to maintain our position as center of clinical excellence for our company and with external collaborators.
- M.D. (Medical Doctor degree) preferred
- Preferred: Relevant experience or specialization in line with our company's portfolio (Infectious Diseases / Preventive Vaccines)
- Preferred: Experience in pharmaceutical clinical development
- Background in clinical immunology is favorable
- 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.
- Excellent oral and written English.
Base Salary - $230,000 to $245,000
2+ to 5 years experience
Seniority Level - Director
Minimum Education - Doctorate Degree
Willingness to Travel - Occasionally
Ideal Candidate, MD with clinical trial and infectious disease experience