Head of Medical Affairs

About the role

Biovac, a leading sterile vaccine manufacturer in Africa, is seeking a dynamic and proactive Head of Medical Affairs to lead the Medical Affairs function across the group. The role will support WHO pre‑qualification, local and export legislation, and drive clinical development for new and existing vaccine products.

Key responsibilities

• Establish and manage the Medical Affairs department, aligning policies with group‑wide clinical trial requirements.
• Oversee end‑to‑end clinical development, including CRO selection, study design, initiation, monitoring, and reporting.
• Coordinate medical communication with healthcare professionals, professional bodies, patient groups, and health authorities.
• Provide scientific input for promotional materials, package inserts, market research, and advisory letters.
• Develop and monitor departmental budgets and expenditures across multiple projects.
• Ensure compliance with cGMP, regulatory standards, and quality audit requirements.

Required profile

• MBChB or equivalent (PhD minimum); postgraduate qualification in clinical medicine or business administration preferred.
• Minimum 8 years of experience in clinical affairs and trial management.
• At least 3 years in senior management with strategic engagement of Key Opinion Leaders.
• Minimum 3 years of pharmacovigilance experience.
• Proven experience in quality and regulatory compliance within a cGMP environment.

Required skills

• Clinical trial management
• Pharmacovigilance
• cGMP compliance
• Project and program management
• Budget development and monitoring
• CRO selection and vendor management
• Biostatistics and clinical study report supervision
• Medical communication with external stakeholders