Global Clinical Development Strategy Expert (Vaccines)

Location: Hybrid role in Waltham, Massachusetts, United States

Company

hirify.global is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines through immunoscience and digital research.

What you will do

• Define clinical development plans aligned with global R&D strategy, franchise priorities, and regulatory requirements.
• Lead the Clinical Team and coordinate monitoring, data management, biostatistics, medical writing, pharmacovigilance, and regulatory affairs.
• Manage clinical development from early-stage research through licensure and commercialization.
• Design safety surveillance processes and clinical safety risk management plans with pharmacovigilance.
• Prepare clinical trial protocols, reports, CTD submissions, and materials for governance and health-authority interactions.
• Build relationships with internal and external collaborators, investigators, opinion leaders, and competent authorities.

Requirements

• MD specializing in dermatology, infectious diseases, pediatrics, internal medicine, or a related field, or a life-science PhD with extensive clinical development experience.
• 5–10+ years of clinical development experience in academia, government, nonprofit, or industry, including vaccine or therapeutics development and clinical strategy.
• Experience working according to GCP and ICH guidelines.
• Experience with regulatory submissions and interactions with health authorities.
• Proven ability to lead transversal teams, work autonomously, manage diverse stakeholders, and drive change.
• Excellent written and spoken English is required.

Nice to have

• Clinical immunology background.
• Experience with therapeutic vaccines, especially vaccines for dermatological conditions such as acne.
• Later-stage clinical development experience and expertise in dermatology, infectious diseases, pediatrics, or internal medicine.

Culture & Benefits

• Work with cross-functional teams spanning science, clinical, and digital disciplines.
• Access structured career paths for scientific and leadership development, including cross-functional moves and short-term assignments.
• Receive a rewards package and employee benefits.
• Benefits include healthcare, prevention and wellness programs, and at least 14 weeks of gender-neutral parental leave.